PRevention of OsTEoporotiC FracTure 2 Pilot Study

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.

Conditions

• Fragility Fracture

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.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Hunan University of Chinese Medicine

  collaborator UNKNOWN

• Longgang Orthopedics Hospital of Shenzhen

  collaborator UNKNOWN

• The First People's Hospital of Hefei

  collaborator OTHER

• Dongguan Eighth People's Hospital

  collaborator UNKNOWN

• The Third People's Hospital of Longgang District Shenzhen

  collaborator UNKNOWN

• Third Affiliated Hospital, Sun Yat-Sen University

  lead OTHER

Principal Investigators

• Jian Mo, MD · Third Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-13

Primary Completion

2025-06-30

Completion

2027-06-30

Countries

• China

Study Locations