PRevention of OsTEoporotiC FracTure 2 Pilot Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorThird Affiliated Hospital, Sun Yat-Sen University

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

Patients with pathological fractures caused by tumor or infection;

Patients with cognitive dysfunction or mental disorder;

AIDS patients;

Patients who refuse to follow-up, or have poor compliance for follow-up, or fail to understand and cooperate for follow-up;

Trial design

Treatments tested in this trial

  • Multifaceted Intervention

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Third Affiliated Hospital, Sun Yat-Sen University

Lead sponsor

Sir Run Run Shaw Hospital

Collaborator

The Second Affiliated Hospital of Hunan University of Chinese Medicine

Collaborator

Longgang Orthopedics Hospital of Shenzhen

Collaborator

The First People's Hospital of Hefei

Collaborator

Dongguan Eighth People's Hospital

Collaborator

The Third People's Hospital of Longgang District Shenzhen

Collaborator