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RECRUITING
NCT06134908
NA

PRevention of OsTEoporotiC FracTure 2 Pilot Study

Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-01-13

Completion Date

2027-06

Last Updated

2024-05-28

Healthy Volunteers

No

Interventions

BEHAVIORAL

Multifaceted Intervention

The multicomponent intervention elements include education for clinicians and patients as well as a shared decision-making program among clinicians and patients. A shared decision-making booklet and a mobile application will be used to promote osteoporosis management and fracture practice.

Locations (7)

The Second Affiliated Hospital of Hunan University of Chinese Medicine

Changsha, China

Dongguan Eighth People's Hospital

Dongguan, China

Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, China

The First People's Hospital of Hefei

Hefei, China

Longgang Orthopedics Hospital of Shenzhen

Shenzhen, China

The Third People's Hospital of Longgang District Shenzhen

Shenzhen, China