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Patient- and Physician-Based Osteoporosis Education

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00073190
Recruitment Status : Completed
First Posted : November 18, 2003
Last Update Posted : December 16, 2013
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Arthritis Foundation
Information provided by (Responsible Party):
Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoporosis Osteoporosis, Postmenopausal Behavioral: Osteoporosis Education Phase 1

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Enrollment : 30000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Official Title: Randomized Controlled Testing of Osteoporosis Education
Study Start Date : September 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00073190

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United States, Massachusetts
Daniel H. Solomon MD, MPH
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Arthritis Foundation
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Principal Investigator: Daniel H. Solomon, MD, MPH Brigham and Women's Hospital
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Responsible Party: Daniel H. Solomon, M.D.,MPH, Professor of Medicine, Brigham and Women's Hospital Identifier: NCT00073190    
Other Study ID Numbers: K23AR048616 ( U.S. NIH Grant/Contract )
K23AR048616 ( U.S. NIH Grant/Contract )
First Posted: November 18, 2003    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: December 2013
Keywords provided by Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital:
Patient Education
Physician Education
Additional relevant MeSH terms:
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Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases