Bone Health

Motivational interviewing and adherence to osteoporosis regimens

Osteoporosis is associated with increased morbidity, mortality, and healthcare costs—billions of dollars annually. Although many types of pharmacotherapy are available to prevent or treat the disease, many patients, for various reasons, do not adhere to their prevention or treatment regimen. In this article the authors show how motivational interviewing, initially created for patients with substance abuse problems, can be used to help patients with osteoporosis overcome their ambivalence toward positive behavior change and better adhere to their prevention or treatment plan.

Key words: osteoporosis, adherence, motivational interviewing, osteoporosis management, osteoporosis drug regimen

Osteoporosis is a chronic metabolic disease of the skeletal system wherein bone resorption exceeds bone formation, leading to low bone mass, marked skeletal fragility, and an increased risk for fracture.1,2 In postmenopausal wo­men, bone loss is related to the effects of aging and the low estrogen state, but it can be exacerbated by immobilization, use of medications such as corticosteroids or gonadotropin-releasing hormones, overexposure to alcohol or tobacco, or nutritional deficiencies related to diet or caused by various malabsorption syndromes.3

In 2010, 10 million persons in the United States and 75 million persons in the Americas, Europe, and Japan were estimated to have osteoporosis.4 Worldwide, the presence of osteoporosis contributes to 9 million fractures annually.4 Osteoporosis-related fractures, particularly those of the hip, are associated with major increases in morbidity, mortality, and healthcare costs.2,5 Risk for such a fracture rises dramatically in women aged 70 years or older.5

Sequelae of hip fracture include declines in physical, mental, and functional health. In many cases, a hip fracture signals the downward spiral of an otherwise healthy and independent elder. In fact, fractures are considered life-threatening events in the elderly.5 In the U.S., osteoporosis-related fractures lead to approximately 4 million days of hospitalization and more than 3 million outpatient and emergency department visits per year.6 About one-half of women who develop a hip fracture rely on others for help with daily activities, one-fifth need long-term care, and one-fifth die within a year.1 The economic burden of osteoporosis in the U.S. is $13-$17 billion a year,1,4,6,7 a figure that is expected to rise to $25 billion by 2025.4,7

Osteoporosis management approaches

Although these statistics provide a grim outlook on the future of osteoporosis, recent scientific advances in the management of patients with osteoporosis may be able to prevent fractures. A wide array of pharmacologic and nonpharmacologic options is already available.6

Pharmacologic interventions work either by accelerating bone regeneration or decreasing bone resorption, resulting in a decreased risk for fracture.1,2 Teriparatide (parathyroid hormone) is the only agent that increases bone mineral density (BMD) anabolically by enhancing bone formation via the osteoblasts. Other osteoporosis medications decrease bone resorption; these antiresorptive agents include the bisphosphonates, the selective estrogen receptor modulators, and denosumab, a monoclonal antibody that limits activation of nuclear factor kappa B ligands, a component of osteoclasts that is important to their formation, function, and survival.4,5 Calcitonin, another antiresorptive agent, is mildly effective in improving BMD of the spine.4

In addition to drug therapy, patients with osteoporosis need to ingest adequate amounts of calcium and vitamin D. Obtaining the recommended 1200-1500 mg of elemental calcium and 1000 IU of vitamin D is difficult for persons following a typical Western diet, so calcium and vitamin D supplementation is often required.3

An important nonpharmacologic intervention for patients with osteoporosis is exercise. Exercise improves muscle efficiency, flexibility, and balance, which results in a decreased risk for falls and, ultimately a decreased risk for fall-related fractures.8 In a randomized controlled trial (RCT), researchers tested the effects of a 44-week exercise program on bone mass, bone quality, and functional capacity in subjects with low BMD.8 The exercise program included a combination of land (weight-bearing) and water (non–weight-bearing) exercises aimed at improving muscle strength, endurance, balance, and joint mobility. Pre- and post-treatment testing showed that bone quality and BMD in the intervention group remained the same and functional capacity improved. Results for the controls, who did not participate in the exercise program, showed a significant decline in bone quality and a decrease in physical function capacity. A meta-analysis of four RCTs on the effects of exercise in postmenopausal women with osteoporosis or osteopenia showed improvements in quality of life, physical function, vitality, and pain.9

Both pharmacologic and nonpharmacologic treatments for osteoporosis have been shown to be effective in reducing bone loss and fracture risk. However, efficacy can be realized only if patients adhere to their management regimen.9 Based on reports in the literature, only about 60% of patients with osteoporosis adhere to their drug regimens.1,2,7 To improve this low rate, nurse practitioners (NPs) first need to understand the reasons for lack of adherence in osteoporosis management.

Adherence in osteoporosis management

Adherence involves a combination of compliance and persistence.2 Compliance refers to the use of medications or other treatments exactly as instructed by a healthcare provider (HCP).1,2,10 With regard to medications, this process includes taking the proper dose at the prescribed frequency and time of day and following specific instructions (eg, taking the medication with food).2 Persistence is defined as following a treatment regimen for as long as it is prescribed.1,2,10 Nonadherence is the failure to comply with precise instructions and/or the premature discontinuation of treatment.

A review of the literature shows various reasons for nonadherence to osteoporosis regimens. A main reason is that osteoporosis is asymptomatic until a fracture occurs; patients are less likely to adhere to a regimen that prevents something from occurring than to a regimen that relieves acute symptoms. In addition, a belief that one’s illness is not serious or life-threatening may result in poor adherence.1,6 Other reasons cited for low adherence among patients with osteoporosis include complexity of the regimen, high frequency of dosing, high cost of medications, adverse side effects, poor understanding about osteoporosis and its chronic nature, and a poor patient–HCP relationship.1,2,6,7,11-13

Nonadherence to osteoporosis regimens results in a significant increase in fracture risk.13 By contrast, even a slight improvement in adherence may result in reduced fracture rates, hospitalization, and general costs of care and lost productivity.1,2,12 In light of the forecast on the personal and financial implications of osteoporosis-related fractures, HCPs must develop strategies that increase adherence to osteoporosis regimens.1,7

Interventions to improve adherence

A post hoc analysis of the results of an RCT was done to ascertain whether patient adherence to osteoporosis regimens would be improved with the use of educational interventions.12 Patients were randomized to an intervention group, who received physician-directed education and additional information about osteoporosis, or a control group, who received usual care without the additional education. Results showed that the additional education on osteoporosis did not improve adherence in the intervention group versus the control group.

A systematic literature review of seven studies focused on various interventions to improve adherence to osteoporosis regimens.7 In two of the studies, the intervention was to provide feedback to subjects regarding their bone turnover markers in response to treatment. Participants in the other five studies received educational material either in person or by brochures, letters, or telephone calls. In the seven studies, the intervention resulting in the greatest improvement in patient adherence was a patient-centered telephonic counseling style used in a nonrandomized investigation by Cook et al.6 This counseling style is similar to motivational interviewing (MI), a technique that facilitates patient self-motivation for treatment and equips patients with information and insight to overcome their own barriers to adherence so that they may improve their ability to manage their condition. Results of the study by Cook et al6 showed that participants who received the intervention had better adherence rates than did those who did not participate. These results suggest the need for further investigation; a blinded RCT is now testing the use of MI to improve adherence to osteoporosis regimens.13

Motivational interviewing

Background—MI was initially developed in the 1980s to help patients reduce substance abuse behaviors (click here for more information).14,15 This patient-centered method of communication aims to evoke one’s own intrinsic motivation for behavior change.16 The philosophy behind the use of MI is that behavior change is complex, and that simply advising patients or prescribing orders to make a change results in temporary change or no change at all.14 Instead, patients are recognized as having the answers they seek and as being experts about their own being.17,18 What impedes motivation, a necessary ingredient for behavior change, is unrecognized ambivalence.17,19 The role of the HCP is to facilitate identification and resolution of this ambivalence,14,16-19 which oftentimes leads to the desired behavior change.

Since its inception, MI has become increasingly used to modify behavior in healthcare domains such as intimate partner violence, smoking cessation during pregnancy, and dialysis adherence in chronic kidney disease.6,18,20,21 MI has a strong theoretical foundation.19 In a review of four meta-analyses on MI, Lundahl and Burke19 concluded that this technique builds on cognitive dissonance theory and self-perception theory to reduce ambivalence and increase motivation needed for change. The patient-centered focus of MI, evident in its therapeutic approach of reflective listening and empathy, is said to be derived from Carl Rogers’ patient-centered therapy.17 MI has been hailed as the clinical application of self-determination theory,18 which states that individuals are innately motivated to improve their own condition and that they are much more likely to adhere to a proposed behavior change if they believe that change is necessary and has personal significance.15 In addition, the self-determination theory suggests that autonomy is ingrained, and that individuals tend to succeed at change when the motivation to do so is of their own volition, as opposed to being influenced from elsewhere.18Learning the MI technique—Successful use of MI in clinical practice requires a certain level of training, but HCPs need not have a background in psychology or counseling.14,22 In a review of meta-analyses on the clinical applicability of MI, Lundahl and Burke19 concluded that the credentials and specific profession of the practitioner had no noteworthy impact on MI outcomes.

Training for MI includes practical exercises in a format wherein MI responses can be checked and modified if needed.22 In a pilot study, researchers aimed to teach a brief version of MI (brief MI) to third-year medical students.23 The researchers first developed a curriculum called CHANGE, a mnemonic that captures the essentials of brief MI: Check patients’ perspective regarding their health and health behaviors; Hear what patients say by using reflective listening skills; Avoid behaviors that are not in alignment with MI; Note patients’ priorities with regard to behavior change; Give feedback to patients only when requested or after permission has been granted; and End the interview by summarizing patients’ own plan for behavior change and healthcare follow-up. These researchers taught six instructors in two 4-hour sessions how to teach CHANGE. The instructors then taught CHANGE to the medical students during one 2-hour session. During the teaching session, students had an opportunity to practice brief MI skills and receive immediate feedback from the instructors, who had been “acting” as patients. In a posttest given right after the training, students showed an increase in their use of brief MI skills, a positive change that held true at a 4-week follow-up.23Applying MI to clinical practice—Practitioners of MI must embrace four key principles and acquire certain therapeutic skills. If properly applied, these principles and skills can help achieve the goal of MI, which is the identification and eradication of patients’ ambivalence toward the desired change.15

Key principles. The first principle of MI is to express empathy for patients’ challenges. In doing so, HCPs show respect for and a nonjudgmental attitude toward patients’ concerns, which fosters a collaborative relationship.15,24 Patients and HCPs work together as equal partners, with HCPs giving direction and support14 while patients supply expertise on their own being.17

The second principle is to develop a discrepancy between patients’ behavior and their personal goals.15,24 To develop this discrepancy, patients are encouraged to outline their own reasons for behavior change. Once this change talk develops, inconsistencies between patients’ current behavior and their stated goal can be identified. It is crucial that patients speak of the inconsistencies; HCPs merely guide them toward recognizing the difference between current action and desire.23 The greater and more obvious the discrepancy, the stronger the motivation to initiate a change.14,15

The third principle is to roll with resistance.24 Patients’ expressions of resistance, whether overt or covert, are indications of ambivalence about change.15 If their ambivalence is ignored or undermined, and HCPs push harder toward change, patients will defend themselves and resist.14 Instead, HCPs must remain nonjudgmental and gently suggest new perspectives for patients to ponder,15,24 which avoids conflict and keeps the lines of communication open.15

The final principle is to support self-efficacy. To achieve this goal, HCPs express belief in patients and their ability to plan and execute change.24 HCPs’ encouragement and positive reinforcement are ongoing. Continued support for self-efficacy empowers patients to believe that they are in control of their own behavior change.15Basic therapeutic skills. To carry out the key principles of MI, certain basic therapeutic skills are utilized.24 An important skill is avoidance of the righting reflex.15 Although HCPs may have certain goals for their patients, accompanied by a powerful drive to see these goals come to fruition,22 they must resist their natural knee-jerk reaction to right or fix things.14,15,22 Instead, they should encourage patients to search within themselves for their own ideas on how to create a change.15

Another important skill to hone is reflective listening,15 which entails summarizing patients’ statements in order to allow patients to correct any misunderstanding. This process enhances understanding between the two parties. In addition, HCPs can selectively reflect on patients’ own statements in favor of change, which encourages further discussion and elicits further change talk by patients.24

Another important therapeutic skill required in MI is asking open-ended questions.15,24 This type of questioning allows patients to do most of the talking while HCPs listen. This practice is especially important in the early stages of communication.24 Responses from open-ended questions can shed light on patients’ goals and values and guide HCPs regarding where to take the conversation next.17,24

The ask-provide-ask approach is yet another useful MI skill. Using this technique, HCPs ask patients to explain what they already know about their behavior or condition. If HCPs deem that additional information is needed, they ask patients for permission to present the information (providing unwanted information can build resistance).14,15 The information is prefaced with permission for patients to disregard it, and is provided in a neutral manner.14 Following the provision of information, patients are given an opportunity to discuss their interpretation of it.14,15

The final therapeutic skill, affirming and summarizing, is used throughout the MI process. Affirmations allow for acknowledgment and compliments for any success, recognition of difficulties, and support and encouragement for positive change. Summaries are used to reiterate statements made by patients during the interview, including those made regarding desire for change and HCPs’ support for fostering this change.14,24

Use of MI precludes HCPs from expressing their own ideas regarding desirable outcomes for patients. This approach does not equate to a lack of care on HCPs’ part, but, rather, represents a realization that within patients is the intrinsic motivation to change their lives.17 Three distinct styles of communication are evident in MI: (1) guiding rather than badgering, (2) encouraging rather than shaming, and (3) negotiating rather than dictating. According to MI’s founding fathers, “it is within the spirit of motivational interviewing that these three styles of communication come together.”22 With adequate MI training and inclusion of key principles and therapeutic skills, HCPs can help patients achieve positive behavior change.

Implications for NPs

With the aging of the U.S. population, the incidence of osteoporosis will increase rapidly in the coming years. Many of these patients will be seen by NPs in primary care and women’s health practices. Ample effective medications are available, along with well-studied exercise regimens. Use of a combination of pharmacologic and nonpharmacologic interventions can help re­duce the risk for osteoporosis-related falls and fractures. However, adherence rates among patients with osteoporosis are historically low. MI has been shown to be effective in helping patients implement favorable behavioral changes, including improved adherence to osteoporosis regimens. The versatility and nearly universal applicability of MI makes this technique fairly easy for NPs to learn and implement in practice, which may significantly alter the course of osteoporosis and osteoporotic fractures in this country.

Conclusion

The foundations of MI are deeply rooted in sound evidence-based theories such as cognitive dissonance theory, self-perception theory, and self-determination theory. This decade-old, patient-centered therapeutic style of communication has been assisting patients in overcoming their ambivalence toward behavior change. MI is not a clever set of tricks used to manipulate patients but, rather, a respectful appreciation of the fact that patients have tools within themselves to create their own change. HCPs’ only objective is to evoke change talk from patients, which then creates a discrepancy between current and desired actions. Finally, gentle guidance toward recognition of the discrepancy heightens patients’ own innate motivation for the sought-after change.

Racquel S. Maccagno is a nurse practitioner at the MinuteClinic in Tampa, Florida. Cathy R. Kessenich is a professor of nursing at the University of Tampa in Tampa, Florida. The authors state that they do not have a financial interest in or other relationship with any commercial product named in this article.

Note to readers: An older version of this article was published in the January/February 2013 issue of AJNP Online.

References

1. Papaioannou A, Kennedy CC, Dolovich L, et al. Patient adherence to osteoporosis medications: problems, consequences, and management strategies. Drugs Aging. 2007;24(1):37-55.

2. Badamgarav E, Fitzpatrick LA. A new look at osteoporosis outcomes: the influence of treatment, compliance, persistence, and adherence. Mayo Clin Proc. 2006;81(8):1009-1012.

3. Binkley N, Krueger D. Current osteoporosis prevention and management. Topics Geriatr Rehabil. 2005; 21(1):17-29.

4. McBane S. Osteoporosis: a review of current recommendations and emerging treatment options. Formulary. 2011;46:432-446.

5. Reginster JY. Antifracture efficacy of currently available therapies for postmenopausal osteoporosis. Drugs. 2011;71(1):65-78.

6. Cook PF, Emiliozzi S, McCabe MM. Telephone counseling to improve osteoporosis treatment adherence: an effectiveness study in community practice settings. Am J Med Qual. 2007;22(6):445-456.

7. Gleeson T, Iversen MD, Avorn J, et al. Interventions to improve adherence and persistence with osteoporosis medications: a systematic literature review. Osteoporosis Int. 2009;20(12):2127-2134.

8. Tolomio S, Ermolao A, Alberto L, Marco Z. The effect of a multicomponent dual-modality exercise program targeting osteoporosis on bone health status and physical function capacity of postmenopausal women. J Women Aging. 2010;22(4):241-254.

9. Wei-Chun L, Yi-Chan C, Rong-Sen Y, Jau-Yih T. Effects of exercise programmes on quality of life in osteoporotic and osteopenic postmenopausal women: a systematic review and meta-analysis. Clin Rehabil. 2009;28:888-896.

10. Hiligsmann M, Gathon HJ, Bru­yère O, et al. Cost-effectiveness of osteoporosis screening followed by treatment: the impact of medication adherence. Value Health. 2010;13(4):394-401.

11. Sanfelix-Genovés J, Gil-Guillén VF, Orozco-Beltran D, et al. Determining factors for osteoporosis patients’ reported therapeutic adherence to calcium and/or vitamin D supplements: a cross-sectional, observational study of postmenopausal women. Drugs Aging. 2009;26(10):861-869.

12. Shu AD, Stedman MR, Polinski JM, et al. Adherence to osteoporosis medications after patient and physician brief education: post hoc analysis of a randomized controlled trial. Am J Manag Care. 2009;15(7):417-424.

13. Solomon DH, Gleeson T, Iversen M, et al. A blinded randomized controlled trial of motivational interviewing to improve adherence osteoporosis medication: design of the OPTIMA trial. Osteoporosis Int. 2010;21(1):137-144.

14. Shannon R, Hillsdon M. Motivational interviewing and musculoskeletal care. Musculoskeletal Care. 2007; 5(4):206-215.

15. McCarley P. Patient empowerment and motivational interviewing: engaging patients to self-manage their own care. Nephrol Nurs J. 2009;36(4):409-413.

16. Apodaca TR, Longbaugh R. Mechanisms of change in motivational interviewing: a review and preliminary evaluation of the evidence. Addiction. 2009;104(5):705-715.

17. Croston M. Motivational interviewing: an overview. HIV Nurs. Autumn 2010;15-18.

18. Neighbors C, Walker DD, Roffman RA, et al. Self-determination theory and motivational interviewing: complementary models to elicit voluntary engagement by partner-abusive men. Am J Fam Ther. 2008;36(2):126-136.

19. Lundahl B, Burke BL. The effectiveness and applicability of motivational interviewing: a practice-friendly review of four meta-analyses. J Clin Psychol. 2009;65(11):1232-1245.

20. Karatay G, Kublay G, Emiroglu ON. Effect of motivational interviewing on smoking cessation and pregnant wo­m­en. J Adv Nurs. 2010;66(6):1328-1337.

21. Russell CL, Cronk NJ, Herron M. Motivational interviewing and dialysis adherence study (MIDAS). Nephrol Nurs J. 2011;38(3):229-236.

22. Wilson H. Implementing motivational interviewing in practice: issues and challenges. HIV Nurs. Autumn 2010;19-21.

23. Martino S, Haeseler F, Belitsky R, et al. Teaching brief motivational interviewing to year three medical students. Med Educ. 2007;41(2):160-167.

24. Levensky ER, Forcehimes A, O’Donohue WT, Beitz K. Motivational interviewing: anevidence-based approach to counseling helps patients follow treatment recommendations. Am J Nurs. 2007;107(10):50-58.

Treating women with osteoporosis: Review and NPWH survey results

The author reviews osteoporosis, including basic facts about the disease, risk factors, prevention, diagnosis, and treatment. In addition, the author presents findings of a National Association of Nurse Practitioners in Women’s Health (NPWH) survey* in which 361 nurse practitioners answered questions about different aspects of caring for their patients with osteoporosis, particularly with regard to treatment options and their benefits and risks.

*This survey was conducted with funding from Mission Pharmacal.

In the United States, 40-52 million adults have either osteoporosis or the low bone mass (LBM) that puts them at increased risk for developing osteoporosis.1,2 Among the 10 million U.S. adults with osteoporosis, about 8 million (80%) are wom­en.3 Data from the 2005-2008 National Health and Nutrition Examination Survey showed that 16% of wom­en aged 50 or older have osteoporosis, and that an additional 61% have LBM at the femur neck or lumbar spine.4 According to the National Osteoporosis Foundation (NOF), osteoporosis is responsible for 2 million broken bones and $19 billion in related costs each year.2 The NOF predicts that the number of osteoporosis-related fractures will rise to about 3 million by 2025, at an annual cost of more than $25 billion.2

Nurse practitioners who care for women are key to helping change the course of osteoporosis-related fractures in the future. By gaining up-to-date knowledge about osteoporosis and its prevention and treatment, NPs can teach patients at risk for LBM and osteoporosis how to protect their bones. And if either LBM or osteoporosis is identified in any of their patients, NPs can implement optimal treatment to prevent further bone loss and avert fractures. This article not only covers the basics about osteoporosis, but it also provides the results of NPWH’s survey of NPs who are already treating women with osteoporosis. The aims of the survey were to…
• Gain additional insight into how NPs treat osteoporosis in their practice;
• Identify NPs’ educational needs with regard to treatment of patients with osteoporosis; and
• Gather feedback that can be used to design or improve the education provided by NPWH about the care of patients with osteoporosis.

Bone and osteoporosis—the basics

Bone consists primarily of collagen, a tough, elastic protein that forms its framework, and calcium phosphate deposits, which harden and strengthen that framework. As a dynamic tissue, bone is constantly being remodeled; new bone is continuously being formed by osteoblasts and old bone is removed by osteoclasts.5 Most people attain their peak bone mass at about age 30, after which the resorption of existing bone slowly begins to exceed the formation of new bone, leading to a decrease in bone mass.1

Osteoporosis literally means porous bone, which describes the LBM and deterioration that characterize this disease.1 Risk for osteoporosis and its related fractures becomes much higher in women at about age 50, when the level of estrogen, which protects against excessive bone loss, declines and bone loss accelerates.3 Osteoporosis is frequently undetected until one or more vertebrae collapse or a fragility fracture occurs.5

Risk factors

Nonmodifiable risk factors for osteoporosis include female gender, increasing age, and having a small, thin-boned body type.1 Caucasian and Asian women are at higher risk than African American and Hispanic women, although the risk is substantial for all women. Heredity may partially account for an increased risk of LBM and a tendency for fractures.

Modifiable risk factors for osteoporosis include having a treatable condition that raises osteoporosis risk, including amenorrhea in younger women, hypoestrogenemia in older women, anorexia nervosa, and a long history of low calcium and vitamin D intake. Long-term use of glucocorticoids or certain anticonvulsants leads to a loss of bone mineral density (BMD). Other risk factors for osteoporosis that can be altered include physical inactivity, extended bed rest, smoking, and excessive alcohol intake.1

Prevention

Preventive measures against osteoporosis must be taken across a lifetime. Women need to build optimal peak bone mass by getting enough calcium and vitamin D and exercising when they are young, while avoiding cigarette smoking and excessive alcohol consumption. NPs need to be aware of medications that can decrease BMD and contribute to increased fracture risk.1 These medications include
• Glucocorticoids: used to treat arthritis, asthma, Crohn’s disease, lupus, and other diseases of the lungs, kidneys, and liver;
• Antiseizure drugs, such as phenytoin and barbiturates;
• Gonadotropin-releasing hormone agents used to treat
endometriosis;
• Excessive use of aluminum-containing antacids;
• Certain cancer treatments; and
• Excessive thyroid hormone treatment.

Following a healthful diet and performing regular exercise remain important even after LBM or osteoporosis has developed. NPs need to assess patients’ daily intake of calcium and vitamin D.6 NPs should recommend that women older than 50 receive calcium 1,200 mg/day and vitamin D 800-1,000 IU/day from food, and supplement their diet only as needed to make up for any shortfall. Every precaution must be taken to keep living and working areas safe so as to prevent falls, a major cause of fractures.1

Diagnosis

Several factors in a woman’s health history are key in terms of ultimately identifying LBM and osteoporosis. In addition to basic information such as age and menopausal status, NPs should check for a personal history of broken bones during adulthood, a family history of osteoporosis and fractures, an adequate intake of calcium and vitamin D, regular exercise and physical activity, smoking and/or drinking alcohol, a history of eating disorders or irregular periods, and any health conditions and/or medications that might affect bone mass. Regular thorough physical examinations can document any height loss and identify spinal changes.7

If osteoporosis is suspected, NPs can order a central dual-energy x-ray absorptiometry (DXA) scan to measure a patient’s BMD. Diagnosis of osteoporosis is made if a woman aged 50 or older has a T-score less than or equal to –2.5 or if a woman has a history of fragility fractures—regardless of BMD. The T-score represents a way of comparing a patient’s BMD with that of a normal reference person aged 30. Low bone mass is defined as a T-score between –1.0 and –2.5; BMD is considered normal if it is –1.0 or higher. In premenopausal wom­en and younger men, a Z-score is used to evaluate BMD; this score compares the person’s BMD to a reference matched for age. Either score is given as a standard deviation from the BMD used as the norm.6 Medicare covers the cost of a DXA scan every 2 years, or more often if deemed necessary.8

A tool to aid practitioners in developing a treatment plan is the World Health Organization fracture risk assessment, or FRAX®, which helps estimate 10-year fracture risk.9 The tool uses an established set of clinical risk factors to compute 10-year fracture risk. FRAX can be used with or without BMD scores. In the U.S., FRAX is especially helpful when determining the best treatment plan for women with LBM but not established osteoporosis. Treatment should be considered for women with low BMD and a 10-year risk of hip fracture of at least 3%, as assessed by FRAX, or a 10-year risk of a major osteoporosis-related fracture of at least 20%, as assessed by FRAX.10

Treatment

Medications prescribed for prevention and/or treatment of osteoporosis include bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin, parathyroid hormone (PTH), estrogen, other types of hormone therapy, and an osteoclast or RANK ligand (RANKL) inhibitor.1 Some bisphosphonates, the RANKL inhibitor denosumab, and teriparatide, the PTH agent, have indications for both women and men, whereas calcitonin, estrogen and other hormone therapies, SERMs, and certain bisphosphonates are approved only for use in women.11 Bisphosphonates are the most common type of anti-osteoporosis medication currently being prescribed.6

Because many of the NPWH survey questions dealt specifically with bisphosphonate therapy, the remaining discussion of medications focuses on this class. Bisphosphonates have a great affinity for bone mineral, which helps increase BMD. These agents also inhibit osteoclast activity, thereby slowing bone turnover.12 Bisphosphonates have proven efficacy in reducing the risk of fractures of the spine, hip, and other nonvertebral sites. In addition, use of these agents has been associated with a significant reduction in morbidity and an increase in survival.13

Bisphosphonate products with an FDA indication include alendronate (Fosamax®, Binosto®),14,15 risedronate (Actonel®, Atelvia®),16,17 ibandronate (Boniva®),18,19 and zoledronic acid (Reclast®).20 Alendronate, ibandronate, zoledronic acid, and risedronate as Actonel® are approved for both prevention and treatment of osteoporosis14-16,18-20; delayed-release risedronate (Atelvia®) is approved only for treatment.17 Ibandronate and delayed-release risedronate have indications for women only17-19; alendronate, risedronate in Actonel®, and zoledronic acid are approved for both women and men.14-16,20 Both formulations of alendronate are taken orally on a weekly basis.14,15 Risedronate is an oral agent that can be taken weekly, monthly, or on 2 consecutive days each month; dosing differs by product.16,17 Ibandronate is taken orally on a monthly basis or given intra­ve­nous­ly (IV) every 3 months.18,19 Zoledronic acid is given IV once a year.20

Oral bisphosphonates are poorly absorbed and, when taken with food, form complexes that cannot be absorbed. Because of this problem, oral bisphosphonates usually must be taken on an empty stomach with plain water,21 followed by a 30- to 60-minute delay before ingestion of any food or beverage.14-16,18 Because of this inconvenient routine, some patients eat and/or drink too soon, thereby negating some or all of the medication effect, or they abandon treatment altogether. Use of IV bisphosphonates can be associated with short-term flu-like symptoms, which occur more often with zoledronic acid than with ibandronate.22

Two newer bisphosphonate products were developed to avoid or minimize the original problems associated with oral dosing. For patients who do not want to wait to eat or drink, delayed-release risedronate (Atelvia),17 which also contains a calcium chelator,21 is taken immediately after breakfast. For patients who do not want to swallow a pill, an alendronate sodium effervescent tablet (Binosto) has been developed15; the tablet is dropped into a small glass of water to create a strawberry-flavored oral solution.

Rare adverse effects of the bisphosphonates

Over the past several years, a growing body of research has identified an increased risk for atypical femoral fracture (AFF) and osteonecrosis of the jaw (ONJ) in bisphosphonate users. It is important for NPs prescribing these medications—or hesitating to do so because of the headlines—to know the facts.

Atypical femoral fracture—Most fractures of the femoral shaft are caused by a major trauma. However, a 2005 report initially raised concern about unusual fractures associated with bisphosphonate use.23 A task force of the American Society for Bone and Mineral research established a list of major features that must be present to classify a femoral fracture as atypical:
• Location anywhere along the femur from just distal to the lesser trochanter to just proximal to the supracondylar flare;
• Association with no or minimal trauma (e.g., a fall from a standing height or less);
• Transverse or short oblique configuration;
• Noncomminuted (not crushed or broken into small pieces); and
• Complete fractures that extend through both cortices and that may be associated with a medial spike; incomplete fractures that involve only the lateral cortex.24

Minor features that are not required for this diagnosis but are sometimes present include bilateral fractures and symptoms, delayed healing, co-morbid conditions (e.g., vitamin D deficiency, rheumatoid arthritis, hypophosphatasia), and use of agents such as bisphosphonates, glucocorticoids, and proton-pump inhibitors, among others.24

Data from a population-based nationwide analysis in Sweden found that the age-adjusted relative risk for AFF in bisphosphonate users was 47.3 and the multivariable-adjusted odds ratio was 33.3.25 However, absolute risk was increased by only 5 cases/10,000 patient-years. A 12-year study showed that although AFF incidence was low, it increased with longer bisphosphonate use.26 A systematic review from the Research on Adverse Drug Events And Reports (RADAR) Project showed that up to 26% of the published cases of AFF in bisphosphonate users had delayed healing or did not heal.27

As a rule, bisphosphonate therapy is considered safe when used for the length of time in the original trials—less than 5 years. Risk for AFFs is increased in patients who have used bisphosphonates for more than 5 years.28 A systematic review of clinical studies of bisphosphonate use in postmenopausal women with osteoporosis found persistent anti-fracture efficacy and increases in BMD beyond 3 years of treatment.29 Some studies in the review showed continuing fracture benefits when patients who had used alendronate or zoledronic acid for 3-5 years discontinued treatment for 3-5 years.

Bisphosphonates are incorporated into bone, allowing them to exert an effect for a time after treatment is discontinued.13 Although there is no formal recommendation for patients at low risk of fracture to take a drug holiday from bisphosphonate therapy, some clinicians think that treatment suspension is appropriate after 5 years.30 However, the benefits of continuing therapy probably outweigh any risk of harm in patients at high risk for fracture—that is, in those with BMD indicating osteoporosis or in those who have sustained a previous fragility fracture.13 Once a patient has been identified as having an AFF, bisphosphonate therapy should be discontinued. Initiating teriparatide therapy may help enhance healing of the fractures.28Osteonecrosis of the jaw—Bisphosphonate-related ONJ occurs when the jaw bone is exposed and begins to die because of a lack of a blood supply.31 One proposed mechanism has to do with the antiangiogenic effect of bisphosphonates. These agents may limit the angiogenesis that is vital to the development of blood vessels in bone, which has a high turnover rate.32 Prevalence of bisphosphonate-related ONJ is between 1/1000 and 1/100,000 for each year of exposure.31 Risk may depend on the bisphosphonate dose, the length of time it has been taken, and the condition for which it has been prescribed. For example, patients with cancer who take IV bisphosphonates are at higher risk for this adverse effect than are patients with osteoporosis taking oral bisphosphonates.31

NPWH survey results

In 2013, NPWH surveyed 411 NPs about different aspects of caring for their patients with osteoporosis. These NPs were located in many different areas of the country, including Western (23.8%), Northeastern (21.9%), Great Lakes (20.0%), Southeastern (16.3%), South Central (14.6%), and North Atlantic (3.4%) regions. Among NPs surveyed, almost two-thirds (63.6%) reported working in an obstetrics/gynecology practice. The group had a great deal of experience; 31.9% had been in practice 11-20 years and 26.8% had been in practice more than 20 years. A total of 361 NPs (87.8%) who replied that they treat patients with osteoporosis completed the survey.

Of these 361 survey respondents, 75.6% first counseled their patients about osteoporosis risk as a routine part of well-woman visits, and 18.0% first addressed this risk when a woman became perimenopausal. Of the 361 NPs, more than three-fourths (75.9%) used a BMD test to make the diagnosis of osteoporosis and 23.5% treated patients who had been diagnosed by another healthcare practitioner. In addition to prescribing medication to reduce their patients’ fracture risk, the NPs recommended adequate calcium and vitamin D intake (97.2%), regular weight-bearing exercise (95.3%), cessation of tobacco use (84.2%), and avoidance of excessive alcohol intake (70.9%). The vast majority of the respondents (90.3%) stated that they wanted to receive more education about the diagnosis and treatment of this disease.

As reflected in the literature, most of these NPs (84.8%) prescribed a bisphosphonate as first-line treatment for osteoporosis. The group was almost evenly split between those who felt oral bisphosphonates were of great value as a treatment option (50.4%) and those who felt these agents were of moderate value (47.9%). Although 53.7% of the NPs have maintained their previous level of prescribing bisphosphonates in the past 2 years, 28.3% had decreased their level. Common concerns about prescribing oral bisphosphonates included patient noncompliance (33.8%), gastrointestinal (GI) problems (28.0%), rare side effects such as ONJ (14.4%), and patients’ failure to fill their prescriptions (10.5%). Only 4.7% of the NPs had no concerns about prescribing these agents. About half of the survey group (51.0%) planned to keep patients on bisphosphonate therapy for 3-5 years; 32.4% of the group were not sure.

The NPs were asked to compare different aspects of alendronate, ibandronate, and rised­ronate. Most respondents (73.1%) thought that all three agents had equal efficacy, whereas 18.6% favored alendronate, 6.1% chose risedronate, and 2.2% selected ibandronate as being more efficacious. When asked to compare the agents with respect to the incidence of GI side effects, 76.7% thought that the agents did not differ in this regard and 11.4%, 9.1%, and 2.8% of the group identified alendronate, rised­ronate, and ibandronate, respectively, as having the lowest incidence of GI side effects. Most respondents (80.6%) thought that branded and generic bisphosphonates did not differ in tolerability, whereas 19.4% favored branded products.

The NPs reported several common patient complaints about oral bisphosphonate therapy. The main problems were having to take the pill in the morning on an empty stomach (35.5%), GI side effects (26.3%), dislike of needing to stay upright after taking the tablet (13.0%), difficulty remembering to take the tablets (12.5%), and feeling that the drug was having no impact (5%).

Almost two-thirds of the respondents (63.4%) said that a monthly tablet would likely improve their patient’s adherence to an oral bisphosphonate regimen; 17.5% suggested a weekly tablet and 11.1% chose a daily tablet. Among respondents who favored weekly dosing, 40% preferred a weekly tablet and 60%, a weekly tablet that dissolves into a drinkable strawberry-flavored solution. When asked specifically about the value of this bisphosphonate solution as a treatment option, 61.5% thought that it would be of moderate value, 27.1% felt it would be of great value, and 11.4% saw it has having no value. Among the 361 NPs surveyed, 79.2% were aware of Binosto alendronate sodium effervescent tablets; however, 93.8% of the 145 NPs who replied to this question had never prescribed this product.

Conclusion

Nurse practitioners who treat women with osteoporosis need to be aware of all the treatment options available. Bisphosphonates are still the first-line choice for patients with low BMD and osteoporosis. New formulations have been developed to address concerns that affect adherence to the regimen. Although NPs need to be aware of the rare adverse effects associated with bisphosphonate use, they also need to keep the low absolute risk in mind when deciding whether or not to prescribe these medications.

Susan Rawlins is Director of Education at the National Association of Nurse Practitioners in Women’s Health and practices at the Greater Texoma Health Clinic in Denison, Texas. Ms. Rawlins is a consultant to Mission Pharmacal.

References
1. NIH Osteoporosis and Related Bone Diseases National Resource Center. Osteoporosis overview. www.niams.nih.gov/Health_Info/Bone/osteoporosis/overview.pdf

2. National Osteoporosis Foundation. What is osteoporosis? http://nof.org/articles/7

3. National Osteoporosis Foundation. What women need to know. http://nof.org/articles/235

4. Looker AC, Borrud LG, Dawson-Hughes B, et al. Osteoporosis or low bone mass at the femur neck or lumbar spine in older adults: United States, 2005-2008. NCHS Data Brief. 2012(93):1-8.

5. NIH Osteoporosis and Related Bone Diseases National Resource Center. Osteoporosis handout on health. www.niams.nih.gov/Health_Info/Bone/Osteoporosis/osteoporosis
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6. Warriner AH, Saag KG. Osteoporosis diagnosis and medical treatment. Orthop Clin North Am. 2013;44(2):125-135.

7. National Osteoporosis Foundation. Making a diagnosis. http://nof.org/
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8. Medicare & You 2014. Centers for Medicare & Medicaid Services: Baltimore, MD. www.medicare.gov/Pubs/pdf/10050.pdf

9. FRAX® WHO Fracture Risk Assessment Tool. www.shef.ac.uk/FRAX/tool.jsp

10. Unnanuntana A, Gladnick BP, Donnelly E, Lane JM. The assessment of fracture risk. J Bone Joint Surg Am. 2010;92(3):743-753.

11. National Osteoporosis Foundation. Treatment with osteoporosis medication. http://nof.org/articles/21

12. Verron E, Bouler JM. Is bisphosphonate therapy compromised by the emergence of adverse bone disorders? Drug Discov Today. August 22, 2013. Epub ahead of print.

13. McClung M, Harris ST, Miller PD, et al. Bisphosphonate therapy for osteoporosis: benefits, risks, and drug holiday. Am J Med. 2013;126(1):13-20.

14. Fosamax® alendronate sodium tablets and oral solution. Prescribing information. Merck & Co., Inc., Whitehouse Station, NJ. 2013. www.merck.com/product/usa/pi_
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15. Binosto® alendronate sodium effervescent tablets for oral solution. Prescribing information. Mission Pharmacal, San Antonio, TX. Rev 2012. http://binosto.com/sites/
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16. Actonel® risedronate sodium tablets. Prescribing information. Procter & Gamble Pharmaceuticals, Inc., Cincinnati, OH. Revised 2013. www.actonel.com/global/prescribing
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17. Atelvia® risedronate sodium delayed-release tablets. Prescribing information. Norwich Pharmaceuticals, Inc., North Norwich, NY. Revised 2013. www.wcrx.com/pdfs/pi/pi_
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18. Boniva® ibandronate sodium tablets. Prescribing information. Roche Laboratories Inc., Nutley, NJ. Revised 2013. www.gene.com/download/pdf/boniva_tablets_prescribing.pdf

19. Boniva® ibandronate injection. Prescribing information. Genentech USA. Inc., South San Francisco, CA. Revised 2013. www.gene.com/download/pdf/boniva_injection_prescribing.pdf

20. Reclast® zoledronic acid injection. Prescribing information. Novartis Pharmaceuticals Corporation, East Hanover, NJ. Revised 2013. www.pharma.us.novartis.com/product/pi/pdf/reclast.pdf

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Healthy bones for women*

 

Osteoporosis is a disease known for slow, silent loss of bone. (In this case, the word “silent” means that you won’t feel anything as the disease starts or worsens.) Bones become thinner and weaker, so they are more likely to fracture—that is, to break. Women are more likely than men to get osteoporosis. Your risk is also higher if someone in your family has had osteoporosis or if at least one of your parents has had a broken hip. More than 1.5 million fractures each year are related, at least in part, to osteoporosis.

Your healthcare professional (HCP) can help you assess your bone health at routine visits by…

Measuring your height.
A loss in height may mean that you have had silent spine fractures. Any loss in height from year to year should be checked further.
Using your height and weight measures together to compute your body mass index (BMI).
A low BMI or a weight less than 127 pounds (thinner women) is a risk factor for osteoporosis.
Reviewing all the medicines you are taking, including prescription and over-the-counter medicines and supplements.
Medicines such as prednisone, some anti depressants, some heartburn/ulcer drugs, and others may increase bone loss.
Discussing whether you should have a blood test to measure your vitamin D level.
Vitamin D is needed to absorb calcium in your bones. A normal blood level of vitamin D is 30 ng/mL or higher. Risk factors for having a low vitamin D level include being older than 60, being obese, having a disease of the kidney or bowel, getting too little sun, having very
dark skin, having had gastric bypass surgery, and using certain medicines. If your vitamin D level is too low, your HCP will prescribe vitamin D supplements and retest your vitamin D level in a few months.
Discussing whether you should have a bone density test.
A bone density test measures bone mass in places such as the lower spine, hip, and forearm. The most common bone density test done is a DXA (dual energy x-ray absorptiometry) scan. You should have this test if you are 65 or older, if you are older
than 50 and have risk factors for osteoporosis, if you broke a bone after age 50, or if you are past menopause and are stopping the use of estrogen. Depending on your test results and your risk factors, and whether you’ve had any osteoporosis treatment, you may need another DXA scan every 2 or more years.

Using a tool called FRAX to see whether you should have a bone density test (if
you are past menopause but not yet 65).
Your HCP may also use FRAX if your bone density test shows low bone mass (but not osteoporosis) to see if you need to be on an osteoporosis prevention medicine. FRAX shows your risk of having a bone fracture in the next 10 years by looking at your risk factors and, if done, your bone density test scores.

You can maintain or improve your bone health by…

Eating the right foods and taking supplements if needed.
You need calcium to make and keep your bones strong. Adult women up to age 50 need 1,000 mg/day and women older than 50 need 1,200 mg/day. Good food sources of calcium are low-fat dairy products, calcium-fortified foods (e.g., cereals, orange juice),
kale, bok choy, halibut, and sardines with bones. Know your usual dietary intake of calcium to decide how much supplement is needed to meet daily requirements. If you take a supplement, it’s best to divide your dose so you take no more than 500 mg of calcium at one time. Calcium carbonate costs the least and is taken with meals to work best. Calcium citrate need not be taken with meals.  You need vitamin D for calcium to be absorbed by your bones. Women younger than 50 need 400-800 IU/day and women older than 50 need 800-1,000 IU/day. Most women do not stay out in the sun long enough for their bodies to make vitamin D. Good food sources of vitamin D are wild salmon, halibut, trout, sardines, and vitamin Dfortified foods (e.g., milk, yogurt, cereals, orange juice). Know your usual dietaryintake of vitamin D to decide how much supplement is needed to meet daily requirements.
Limiting your intake of sodium, which reduces calcium absorption.
Look for sodium content on food labels. Avoid processed and canned foods and
salted snack foods and nuts. Eat fresh or frozen fruits and vegetables and fresh
lean meats, poultry, and fish.
Getting regular exercise, which helps make your bones strong.
Plan to get at least 30 minutes of moderate weight-bearing exercise on most
days of the week. Weight-bearing exercises include brisk walking, running/jogging, dancing, stair climbing, tennis, and use of exercise equipment such as elliptical training and stair-step machines and treadmills. Plan to do muscle strengthening exercises 2 or 3 days each week. You can lift weights, use weight machines, or use elastic exercise bands. Yoga and Pilates can improve strength, flexibility, and balance.
Not smoking.
Smoking decreases calcium absorption and speeds up bone breakdown.
Drinking alcohol in moderation.
For women, this is no more than 2 drinks each day. One drink = 10 ounces of beer, 4 ounces of wine,or 1 ounce of liquor. Drinking heavily can lead to bone loss.

Resources for more information

National Osteoporosis Foundation
4BoneHealth
FRAX calculator

*Readers are invited to photocopy Patient education pages in the journal and distribute them to their patients.