PRevention of OsTEoporotiC FracTure 2 Pilot Study

Not Applicable

Recruiting

• Conditions: Fragility Fracture
• Interventions: Behavioral: Multifaceted Intervention

• Registration Number: NCT06134908
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-11
• Study First Submitted QC: 2023-11-11
• Study First Posted: 2023-11-18
• Study Start: 2024-01-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-28
• Primary Completion: 2025-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Local residents (live in the city where the hospital is located for half a year or more);
2. Hospitalized patients with fractures aged 50 years and above;
3. First fracture, without history of fracture;
4. Never diagnosed as "osteoporosis" before admission;
5. No fracture history, and never receive any bone mineral density test, and never take anti-osteoporosis medication in the 4 years before admission;
6. Hospitalized patients with the following fractures: hip fracture, thoracic spine fracture, and lumbar spine fracture;
7. 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;
8. Not living in a nursing or rehabilitation institution before fracture;
9. Possess reading ability, and can read and understand informed consent forms or medical materials independently.

Exclusion Criteria

1. Patients with pathological fractures caused by tumor or infection;
2. Patients with cognitive dysfunction or mental disorder;
3. AIDS patients;
4. Patients who refuse to follow-up, or have poor compliance for follow-up, or fail to understand and cooperate for follow-up;
5. Hearing or visual impairment, and unable to communicate or read materials;
6. Patients who have participate in other studies;
7. Other conditions that the investigator considered inappropriate to enroll.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multifaceted Intervention	Multifaceted Intervention	Group in the intervention arm will receive a multicomponent intervention at the clinician- and patient-level, with a shared decision-making booklet as well as a mobile application to promote osteoporosis management and fracture practice.

Primary Outcome Measures

Name	Time	Method
Trial feasibility - Retention	30 days after study recruitment	The retention rates will be assessed as the 30-day follow-up rate.
Trial feasibility - Recruitment	3 months	Number or N (%) participants recruited within 3 months of trial initiation at each centre.
Trial feasibility - Acceptability of the multicomponent program component	30 days after study recruitment	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.
Trial feasibility - Acceptability of the shared decision-making process	7 days after study recruitment	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.

Secondary Outcome Measures

Name	Time	Method
Shared decision-making process	7 days after study recruitment	Standardized questionnaires will be used to evaluated the shared decision-making process.
Survival	1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up	The patients will be followed up about their survival status.
Patients' knowledge and attitude about osteoporosis and fragility fracture	baseline; 1 month follow-up; 6 month follow-up	Patients' knowledge and attitude about osteoporosis and fragility fracture will be evaluated with standardized questionnaires.
Refracture	1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up	The patients will be followed up and asked whether they have refracture.
Adherence of anti-osteoporosis medication	1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up	Adherence of anti-osteoporosis medication will be assessed with medication possession ratio and self-reported question.
Anti-osteoporosis treatment rate	1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up	The patients will be followed up and asked whether they accept any anti-osteoporosis medication.
Bone mineral density test	3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up	The patients will be followed up and asked whether they accept bone mineral density test.
Diagnosis, education, and follow-up practice of osteoporosis	1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up	The patients will be followed up with questionnaires about diagnosis, education, and follow-up of osteoporosis.

Trial Locations

Locations (7)

Dongguan Eighth People's Hospital; 🇨🇳 Dongguan, China

The First People's Hospital of Hefei; 🇨🇳 Hefei, China

Third Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, China

The Third People's Hospital of Longgang District Shenzhen; 🇨🇳 Shenzhen, China

Longgang Orthopedics Hospital of Shenzhen; 🇨🇳 Shenzhen, China

The Second Affiliated Hospital of Hunan University of Chinese Medicine; 🇨🇳 Changsha, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, China