PRevention of OsTEoporotiC FracTure 2 Pilot Study (NCT06134908) | Clinical Trial Compass
RecruitingNot Applicable
PRevention of OsTEoporotiC FracTure 2 Pilot Study
China50 participantsStarted 2024-01-13
Plain-language summary
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.
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
✓. Local residents (live in the city where the hospital is located for half a year or more);
✓. Hospitalized patients with fractures aged 50 years and above;
✓. First fracture, without history of fracture;
✓. Never diagnosed as "osteoporosis" before admission;
✓. No fracture history, and never receive any bone mineral density test, and never take anti-osteoporosis medication in the 4 years before admission;
✓. Hospitalized patients with the following fractures: hip fracture, thoracic spine fracture, and lumbar spine fracture;
✓. New fragility fracture: fracture that occurs after minor trauma or daily activities, such as a fracture caused by a fall from standing height or less; fracture happened within 6 weeks;
✓. Not living in a nursing or rehabilitation institution before fracture;
Exclusion criteria
✕. Patients with pathological fractures caused by tumor or infection;
What they're measuring
1
Trial feasibility - Recruitment
Timeframe: 3 months
2
Trial feasibility - Acceptability of the multicomponent program component
Timeframe: 30 days after study recruitment
3
Trial feasibility - Acceptability of the shared decision-making process
Timeframe: 7 days after study recruitment
4
Trial feasibility - Retention
Timeframe: 30 days after study recruitment
Trial details
NCT IDNCT06134908
SponsorThird Affiliated Hospital, Sun Yat-Sen University