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.

Condition	Treatment or Intervention	Phase
Osteoporosis Osteoporosis, Postmenopausal	Behavior: Osteoporosis Education	Phase I

Further Study Details: 

Expected Total Enrollment:  30000

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.

Ages Eligible for Study:  65 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria For Patients:

• PACE beneficiaries who filled at least one prescription for a drug of any type in the year prior to the study
• At high risk for osteoporosis: women and men 75 years or older, patients taking glucocorticoids or psychoactive medications, patients diagnosed with rheumatoid arthritis, and patients with a past fracture
• Have had an outpatient visit with a participating doctor based on Medicare outpatient claims

Inclusion Criteria For Physicians:

• Primary prescribing physicians for PACE beneficiaries

Massachusetts
      Daniel H. Solomon MD, MPH, Boston,  Massachusetts,  02115,  United States

Study chairs or principal investigators

Daniel H. Solomon, MD, MPH,  Principal Investigator,  Brigham and Women's Hospital   

Study ID Numbers:  NIAMS-074; K23 AR48616
Record last reviewed:  November 2004
Last Updated:  November 12, 2004
Record first received:  November 17, 2003
ClinicalTrials.gov Identifier:  NCT00073190
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08