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PRevention of OsTEoporotiC FracTure 2 Pilot Study

Study acronym: PROTECT-2
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 28, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Study sites: 1 to 7
    • Start date changed from estimate of Nov 2023 to Jan 13, 2024
    • Collaborators expanded, about 39 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
With the aging of the world population, osteoporosis and fragility fractures have become global public health concerns. It has been estimated the population of people ≥60 years of age will increase from 229 million (16.2%) in 2017 to 479 million (35.1%) by 2050 in China. Because age is an important predictor of osteoporosis and fragility fracture, the incidence of fragility fracture has increased dramatically in China over the past decades. Timely treatment of osteoporosis is an effective way to decrease additional fracture risk among patients with fragility fractures, but anti-osteoporosis treatment rate is relatively low in China. Effective fracture prevention intervention is urgently needed in China. As a potential way to achieve effective risk communication, shared decision-making allows patients to be active participants in the management of osteoporosis. The investigators designed a multifaceted intervention, which was named as "Precise Education + Shared Decision-Making" program for the secondary prevention of fragility fractures based on behavioral theories, and assessed the effectiveness for fracture prevention using a pilot cluster randomized controlled trial among several hospitals in China. The aim of this pilot study is to test the acceptability and feasibility as well as preliminary efficacy of this program in patients with fragility fractures.
Trial Details
NCT Number NCT06134908
Lead Sponsor Third Affiliated Hospital, Sun Yat-Sen University
Collaborators: Sir Run Run Shaw Hospital, The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Longgang Orthopedics Hospital of Shenzhen, The First People's Hospital of Hefei, Dongguan Eighth People's Hospital, The Third People's Hospital of Longgang District Shenzhen
Conditions
(from sponsor)
Fragility Fracture
Related terms Osteoporosis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov