Osteoporosis Clinical Trial
Official title:
Randomized Controlled Testing of Osteoporosis Education
Osteoporosis is an important public health problem. Osteoporosis can cause serious health complications and death and leads to increased medical costs. The purpose of this study is to identify an effective method of educating patients and health care professionals about the diagnosis and treatment of osteoporosis.
Osteoporosis affects a large and growing proportion of the population. Multiple drugs for
the prevention and treatment of osteoporosis have been developed, tested, and proven
effective in the last decade. However, these drugs may not always be adequately prescribed.
Several effective nonpharmacological measures also exist for preventing fractures; strength
and gait training, home safety modifications, and other lifestyle modifications have all
been shown in carefully conducted trails to reduce the risk of falls that lead to
osteoporotic fractures. Yet these interventions are under-utilized. Practical public health
strategies are needed to bring these experimental findings to widespread use in typical
populations of at-risk patients. This study will evaluate innovative fracture prevention
interventions targeted to both patients and doctors. Specifically, the study will compare
the effects of the patient and physician behavior change intervention alone and in
combination on prescribing patterns for osteoporosis therapies and will examine the
interventions' effects on fracture prevention behaviors other than medication use.
The patient intervention will consist of two mailings and will be targeted using clinical
and demographic data from the State of Pennsylvania's Pharmaceutical Assistance Contract for
the Elderly (PACE) and Medicare databases. The first mailing will introduce the topic of
osteoporosis and explain why osteoporosis is an important topic for all those receiving the
mailing. The second mailing, sent the following month, will reinforce the first mailing and
contain patient-specific information based on demographic and clinical factors. This mailing
will also focus on several proven prevention strategies, including strength and gait
training, vision care, home safety improvements, calcium intake, and pharmaceutical
enhancement of bone density.
The physician intervention will be multifaceted and will include a mailed practice audit and
one-on-one education through academic detailing. The mail audit will contain information on
the physician's PACE patients and an assessment of their osteoporosis risk based on clinical
and drug data. Following the mailing, an academic detailer will meet with the physicians
receiving the intervention.
Outcome measures will include questionnaires, medication use, Dual Energy X-ray
Absorptiometry (DEXA) scans, and use of physical therapy.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind
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