PRevention of OsTEoporotiC FracTure 2 Pilot Study
ConditionFragility Fracture
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Multifaceted Intervention
BehavioralThe 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Multifaceted InterventionExperimental treatment 1 intervention
Group B: Usual-care ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Trial feasibility - Recruitment
Number or N (%) participants recruited within 3 months of trial initiation at each centre.
Time frame
3 months2
Trial feasibility - Acceptability of the multicomponent program component
Participants will be asked to evaluate the program with a questionnaire with questions about frequency, length, content, delivery, and duration of the booklet and the mobile application using a 5-point Likert scale.
Time frame
30 days after study recruitment3
Trial feasibility - Acceptability of the shared decision-making process
Both clinicians and patients will be asked to evaluate the shared decision-making process once they completed it. A survey will be administered to evaluate the content and comprehension of the program using a 5-point Likert scale.
Time frame
7 days after study recruitment4
Trial feasibility - Retention
The retention rates will be assessed as the 30-day follow-up rate.
Time frame
30 days after study recruitmentSecondary outcomes
1
Anti-osteoporosis treatment rate
The patients will be followed up and asked whether they accept any anti-osteoporosis medication.
Time frame
1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up2
Shared decision-making process
Standardized questionnaires will be used to evaluated the shared decision-making process.
Time frame
7 days after study recruitment3
Bone mineral density test
The patients will be followed up and asked whether they accept bone mineral density test.
Time frame
3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up4
Adherence of anti-osteoporosis medication
Adherence of anti-osteoporosis medication will be assessed with medication possession ratio and self-reported question.
Time frame
1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov