deltatrials
Completed PHASE1 INTERVENTIONAL NCT00073190

Patient- and Physician-Based Osteoporosis Education

Randomized Controlled Testing of Osteoporosis Education

Sponsor: Arthritis Foundation

Updated 6 times since 2017 Last updated: Dec 13, 2013 Started: Sep 30, 2003 Primary completion: Jun 30, 2006 Completion: Jun 30, 2006
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00073190, this PHASE1 trial focuses on Osteoporosis and Osteoporosis, Postmenopausal and remains completed. Sponsored by Arthritis Foundation, it has been updated 6 times since 2003, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

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 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.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Present [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE1

    First recorded

Sep 2003

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Arthritis Foundation
  • Brigham and Women's Hospital
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Data source: Brigham and Women's Hospital

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations