PRevention of OsTEoporotiC FracTure 2 Pilot Study

Fragility Fracture Clinical Trial

— PROTECT-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06134908
• Other study ID #: PROTECT-2 Pilot
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2024
• Est. completion date: June 2027

Study information

• Verified date: May 2024
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Jian Mo, MD
• Phone: +86 (020) 85252900
• Email: mojian3[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2027
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Fragility Fracture

Intervention

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

Country	Name	City	State
China	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

Sponsors (7)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University	Dongguan Eighth People's Hospital, Longgang Orthopedics Hospital of Shenzhen, Sir Run Run Shaw Hospital, The First People's Hospital of Hefei, The Second Affiliated Hospital of Hunan University of Chinese Medicine, The Third People's Hospital of Longgang District Shenzhen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trial feasibility - Recruitment	Number or N (%) participants recruited within 3 months of trial initiation at each centre.	3 months
Primary	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.	30 days after study recruitment
Primary	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.	7 days after study recruitment
Primary	Trial feasibility - Retention	The retention rates will be assessed as the 30-day follow-up rate.	30 days after study recruitment
Secondary	Anti-osteoporosis treatment rate	The patients will be followed up and asked whether they accept any anti-osteoporosis medication.	1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up
Secondary	Shared decision-making process	Standardized questionnaires will be used to evaluated the shared decision-making process.	7 days after study recruitment
Secondary	Bone mineral density test	The patients will be followed up and asked whether they accept bone mineral density test.	3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up
Secondary	Adherence of anti-osteoporosis medication	Adherence of anti-osteoporosis medication will be assessed with medication possession ratio and self-reported question.	1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up
Secondary	Diagnosis, education, and follow-up practice of osteoporosis	The patients will be followed up with questionnaires about diagnosis, education, and follow-up of osteoporosis.	1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up
Secondary	Refracture	The patients will be followed up and asked whether they have refracture.	1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up
Secondary	Survival	The patients will be followed up about their survival status.	1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up
Secondary	Patients' knowledge and attitude about osteoporosis and fragility fracture	Patients' knowledge and attitude about osteoporosis and fragility fracture will be evaluated with standardized questionnaires.	baseline; 1 month follow-up; 6 month follow-up