Menopause Live (12 December, 2011) from IMS

Li and associates have recently reported a study aimed at estimating persistence with osteoporosis therapies and assessing persistence by different users (stable and switching), type of osteoporosis drug, and calendar year of initiation among postmenopausal women, 50 or more years old included in UK General Practice Research Database (GPRD) between January 1995 and March 2008 [1]. Persistence with osteoporosis medications was estimated as the proportion of women who continued therapy at 6 months and at 1, 3, and 5 years. During the study period, there were 66,116 women who had a first-ever prescription for an oral bisphosphonate, oral raloxifene, or oral strontium ranelate. Diagnosis of osteoporosis was not an inclusion criterion and the most frequent female co-morbidities were heart disease, chronic pulmonary disease, rheumatoid arthritis, diabetes mellitus, hyperthyroidism, inflammatory bowel disease and chronic liver disease. Overall, women were continuing with osteoporosis therapy at 6 months after the index date in the full study population in 44% of episodes and in 32%, 16%, and 9% of episodes at 1, 3, and 5 years later, respectively. At 6 months from initiation, monthly ibandronate treatment and weekly alendronate and risedronate treatment had the highest persistence rates, 56.8%, 52.8, and 53.1%, respectively. Daily alendronate and strontium ranelate had the lowest persistence rates (27.0% and 30.0%, respectively). The authors concluded that persistence with osteoporosis therapies had improved over the study period, but persistence in the first 6 months remained below 50%, leaving a large unmet need to improve the management of postmenopausal women through novel adherence programs and therapies.

Comment
During the last 20 years, diagnosis of osteopenia and osteoporosis has improved remarkably, allowing the early detection of women at risk of suffering low-intensity or fragility fractures. As a result of increased life expectancy, currently women spend more than one-third of their lives in a state of estrogen deprivation, which in turn leads to a number of significant long-term changes. Hence, osteoporosis is highly prevalent among postmenopausal women.

Treatment of osteoporosis involves lifestyle changes (i.e. diet and exercising) and also pharmacological therapy, both aimed at increasing bone mass and resilience. In order to prevent fractures, osteoporosis medications are prescribed for prolonged periods of time. Many fragility microfractures are not recognized or are devoid of clinical symptoms, and thus patients may not perceive treatment benefits. This situation may, in fact, decrease long-term compliance. Advanced osteoporosis (very low bone mineral density) may lead to multiple fractures, stooped posture, loss of height, chronic pain and reduced mobility. In addition, there are some diseases and treatments that increase osteoporosis risk, such as those described in the studied GPRD population. Therefore, after providing a detailed pathophysiological explanation for the spontaneous clinical course of the disease and the risk of fractures, osteoporosis treatment (healthy lifestyle and pharmacological agents) requires a high degree of adherence and persistence. 

Reports indicate that osteoporosis treatment with any of compounds analyzed in the study by Li and colleagues [1] reduces the incidence of low-intensity fractures in a wide variety of populations at risk [2-5]. Data supporting treatment efficacy have been drawn from controlled clinical trials. Despite this, in ‘day-to-day clinical practice’ (outside clinical trials), patient adherence and persistence to therapy are, in fact, not as high as those found in controlled trials.

Primary non-adherence among patients may vary in relation to disease or health conditions, personality and type of therapy [6]. In the US, reports indicate that only 50% of patients adhere to treatments for chronic illnesses or improvement of lifestyle habits [7,8]. One-third of patients do not take properly or appropriately adhere to their medication, exposing themselves to additional risks and increasing mortality rate twofold [9,10].

Factors involved in treatment adherence may vary among patients. Moreover, each patient has an individual perception regarding whether she or he is being persistent or not to one medication or another [11,12]. Thus, higher perception of treatment need, disease severity, satisfaction with physician consultation, fewer side-effect concerns, and knowledge about disease and medication may increase adherence [13]. Interventions aimed at increasing adherence should be tailored according to the patient’s beliefs and medication characteristics. Communication has a relevant role in health literacy regardless of the patient’s level of education. Clinicians should provide comprehensive educational materials that may strengthen compliance with osteoporosis medication. On the other hand, new educational programs directed at patients should be developed to increase awareness of osteoporosis and fractures, treatment benefits and cautions and lifestyle changes. Internet-based information may also be an easy way to develop and obtain comprehensive, good-quality educational material without commercial bias [14]. Pharmacists may also have an important role in improving medication adherence, although their role in long-term treatments is not well known. Physicians and other health-care professionals for women should improve their knowledge of the importance of compliance with osteoporosis medication. In the American population, low satisfaction with osteoporosis treatment is associated with 22–67% increased risk of stopping or changing medication during the first year of prescription [15]. In Europe, poor persistence with osteoporosis treatment has resulted in a failure to significantly reduce fracture risk [16].

A better approach to the woman with bone loss and risk of fractures would contribute to increasing the therapeutic effects of osteoporosis medications, reducing morbidity and mortality, and lower health-care costs linked to the management of osteoporosis and its complications. New treatments are available with longer administration intervals: given monthly, quarterly, every semester or even annually. It remains, however, to be determined whether these therapeutic options will succeed in increasing adherence and decreasing adverse events. There is a need for future amelioration management in women with bone mass loss who are at risk for fractures.