Actively Recruiting
PRevention of OsTEoporotiC FracTure 2 Pilot Study
Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2024-05-28
50
Participants Needed
7
Research Sites
176 weeks
Total Duration
On this page
Sponsors
T
Third Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor
S
Sir Run Run Shaw Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PRevention of OsTEoporotiC FracTure 2 Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Local resident living in the city of the hospital for at least 6 months
- Hospitalized with a fracture and aged 50 years or older
- First fracture with no previous history of fractures
- Never diagnosed with osteoporosis before this hospital admission
- No fracture history or bone mineral density test and no anti-osteoporosis medication in the past 4 years
- Hospitalized with hip, thoracic spine, or lumbar spine fracture
- New fragility fracture caused by minor trauma or daily activities within the last 6 weeks
- Not living in nursing or rehabilitation institution before fracture
- Able to read and understand informed consent and medical materials independently
You will not qualify if you...
- Fractures caused by tumors or infections (pathological fractures)
- Cognitive dysfunction or mental disorders
- AIDS diagnosis
- Refusal or inability to comply with follow-up
- Hearing or vision impairment that prevents communication or reading
- Participation in other clinical studies
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
The Second Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, China
Actively Recruiting
2
Dongguan Eighth People's Hospital
Dongguan, China
Actively Recruiting
3
Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Actively Recruiting
4
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
5
The First People's Hospital of Hefei
Hefei, China
Actively Recruiting
6
Longgang Orthopedics Hospital of Shenzhen
Shenzhen, China
Actively Recruiting
7
The Third People's Hospital of Longgang District Shenzhen
Shenzhen, China
Actively Recruiting
Research Team
J
Jian Mo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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