NCT06134908Recruiting
PRevention of OsTEoporotiC FracTure 2 Pilot Study
The Application of "Precise Education + Shared Decision-Making" Program for the Secondary Prevention of Fragility Fractures Based on Behavioral Theories: A Pilot Cluster Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 28 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 11 Nov 2023
- Start date
- 13 Jan 2024
- Primary completion date
- Jun 2025
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Diseases
- Osteoporosis
- NCT number
- NCT06134908
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 13 Jan 2024 to the primary completion date, Jun 2025
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with pathological fractures caused by tumor or infection;
- Patients with cognitive dysfunction or mental disorder;
- Hearing or visual impairment, and unable to communicate or read materials;
- Other conditions that the investigator considered inappropriate to enroll.
Other
- AIDS patients;
- Patients who refuse to follow-up, or have poor compliance for follow-up, or fail to understand and cooperate for follow-up;
- Patients who have participate in other studies;
Who the study is looking for
- 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;
- Possess reading ability, and can read and understand informed consent forms or medical materials independently.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Hunan University of Chinese Medicine Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Dongguan Eighth People's Hospital Coordinator of this site? Confirm its status | Dongguan | China | Recruiting |
| Third Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First People's Hospital of Hefei Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Longgang Orthopedics Hospital of Shenzhen Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| The Third People's Hospital of Longgang District Shenzhen Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.