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Completed

NCT Number: NCT00073190

Patient- and Physician-Based 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Daniel H. Solomon MD, MPH

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteoporosis Education

Behavioral

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Arthritis Foundation
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Randomized Controlled Testing of Osteoporosis Education

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Nov 18, 2003
Registry last updated
Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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