Abstract and Introduction
Abstract
Purpose. Trends in the use of different treatments for osteoporosis among the civilian, ambulatory U.S. population are described.
Methods. Data from the Medical Expenditure Panel Survey (MEPS) were used to estimate osteoporosis prevalence and treatment rates among individuals ages 50 years and older who self-reported having osteoporosis. Specific pharmacologic treatments analyzed included oral and transdermal estrogen and estrogen and progesterone combination products in women, injectable and transdermal testosterone products in men, oral bisphosphonate medications, raloxifene, and nasal calcitonin. Predisposing characteristics included sex, age, education, income, and race. Required characteristics included the use of an oral corticosteroid medication, having a fracture in the current MEPS year, presently smoking, and self-report of fair or poor health status.
Results. Self-report of osteoporosis increased steadily from approximately 3.2 million patients in 1999 to 7.2 million patients in 2005. This was associated with an increase of the number of patients who used medication for the treatment of osteoporosis from 2.3 million in 1999 to 5.6 million in 2005. Although medication use increased over time, only 77% of people with osteoporosis reported using medication for the treatment of osteoporosis in the previous year. Only 25.4% of men, 55.6% of blacks, 64.2% of patients without a usual source of health care, and 66.8% of patients who reported their health as fair or poor used medication for the treatment of osteoporosis in the previous year.
Conclusion. Although the MEPS data are based on patient self-report, the results from our study suggest that approximately one in four patients with osteoporosis did not receive prescription management for this condition.
Introduction
Osteoporosis represents a growing public health problem for both men and women in the United States. According to the National Osteoporosis Foundation, an estimated 44 million people in the United States over age 50 were afflicted with either osteoporosis or osteopenia, its clinical precursor, in 2002. Of these, 10 million people (8 million women and 2 million men) had clinically defined osteoporosis. The defining characteristic of osteoporosis is reduced bone mass, making individuals more susceptible to fractures of the hip, spine, and wrist. It has been estimated that osteoporosis accounts for more than 1.5 million fractures in the United States each year. These fractures result in significant morbidity and mortality, with hip fractures being the most disabling. More than 50% of patients who have incurred a fracture of the hip are institutionalized and up to 20% die within one year of injury. This has substantial economic consequences, with direct costs attributable to osteoporotic fractures in 1995 estimated at $14 billion.
The foundation of osteoporosis prevention remains adequate consumption of calcium and vitamin D. However, for patients with clinically defined osteoporosis, current clinical guidelines also recommend the use of prescription medication for management of osteoporosis. Hormone therapy, either as estrogen monotherapy or estrogen in combination with progesterone, has historically been an attractive treatment option for clinicians treating osteoporosis in postmenopausal women. Hormone therapy has been shown to improve bone mineral density and reduce fracture rates in women. However, since publication of the results of the Women's Health Initiative trial in 2002, hormone therapy is no longer considered a viable treatment option for osteoporosis. The results of the Women's Health Initiative trial suggested an increased risk of cardiovascular disease, breast cancer, and stroke among postmenopausal women receiving combination therapy with estrogen and progesterone. In addition, an increased risk of stroke was observed among women who received conjugated equine estrogen monotherapy following hysterectomy.
With the confirmation of serious adverse effects related to hormone therapy, there has been an increase in the use of newer agents for treatment of osteoporosis. The most commonly used medications for the treatment of osteoporosis are the bisphosphonates. Bisphosphonate medications that are currently available in the United States include the oral medications alendronate (Fosamax, Merck, Whitehouse Station, NJ), risedronate (Actonel, Procter & Gamble, Cincinnati, OH), and ibandronate (Boniva, Roche, GlaxoSmithKline, Research Triangle Park, NC) as well as the i.v. bisphosphonate zoledronic acid (Reclast, Novartis, Basel, Switzerland). Numerous studies have shown these medications to be effective at reducing vertebral and nonvertebral fractures in patients with osteoporosis. Current clinical recommendations suggest using bisphosphonates as a primary treatment option for osteoporosis in both men and women.
Two additional medications with the Food and Drug Administration-approved labeling for the treatment of osteoporosis in both men and women are nasally administered calcitonin (Miacalcin, Novartis) and the parathyroid hormone teriparatide (Forteo, Eli Lilly, Indianapolis, IN). Although effective for patients who may not tolerate other treatment options, these medications are not considered first-line therapy for different reasons. Nasal calcitonin is generally reserved as a second-line treatment option because of questions concerning its relative clinical effectiveness in comparison with other therapeutic alternatives. Teriparatide is reserved as a lower-tier treatment option because of its expense, subcutaneous route of administration, and questions surrounding its potential to cause osteosarcoma.
Finally, two gender-specific osteoporosis treatment options include the selective estrogen-receptor modulator raloxifene (Evista, Eli Lilly) and injectable or transdermal testosterone. In the MORE (Multiple Outcomes of Raloxifene Evaluation) study, raloxifene was shown to significantly reduce vertebral fracture rates in women with osteoporosis compared with women receiving placebo. Given its clinical effectiveness, raloxifene is considered a first-line treatment option. However, because it is an estrogen-receptor modulator, raloxifene is only approved for marketing for osteoporosis treatment and prevention in postmenopausal women. Finally, testosterone therapy is indicated as a third-line treatment option for osteoporosis in men with hyogonadism.
Despite the fact that numerous treatment options are available to clinicians, osteoporosis remains a significantly underrecognized and undertreated condition. Studies have shown that even after the occurrence of a fracture, clinicians tend not to prescribe diagnostic testing or treatment for osteoporosis. Results of one study showed that only 23 of 88 patients (26%) followed for one year after admission to a university hospital for a low-impact hip fracture received any medication treatment for osteoporosis. Even after treatment is initiated, adherence with medications for osteoporosis has been shown to be suboptimal. In an examination of adherence among patients in a large U.S. managed care organization, only 26% of patients were adherent to their osteoporosis treatment when followed over time. Of particular concern, nonadherence in this study was associated with a 17% increased risk of fracture after controlling for other risk factors.
The objectives of this study were to describe trends in the use of different treatments for osteoporosis among the civilian, ambulatory U.S. population; document rates of pharmacologic treatment among patients with osteoporosis; and describe the influence of patient characteristics on the use of different types of medication for treatment of osteoporosis.