Program to prevent fragility fractures in older adults

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

This study is testing a new program to help older adults in China who have had their first fragility fracture learn about and take part in their osteoporosis treatment to prevent future fractures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University (Academic / other)
• Locations: 7 sites (Changsha and 6 other locations)
• Trial ID: NCT06134908 on ClinicalTrials.gov

What this trial studies

This program aims to address the rising incidence of fragility fractures among the aging population in China by implementing a multifaceted intervention that combines precise education and shared decision-making. The approach encourages patients aged 50 and above, who have recently experienced their first fragility fracture, to actively participate in their osteoporosis management. By improving communication and understanding of treatment options, the program seeks to increase the rate of anti-osteoporosis treatment among eligible patients. The intervention is particularly focused on those who have not previously been diagnosed with osteoporosis or received treatment.

Who should consider this trial

Good fit: Ideal candidates for this program are hospitalized patients aged 50 and above who have experienced their first fragility fracture and have not been previously diagnosed with osteoporosis.

Not a fit: Patients with a history of osteoporosis diagnosis or those who have received anti-osteoporosis medication in the past four years may not benefit from this program.

Why it matters

Potential benefit: If successful, this program could significantly reduce the risk of future fractures in older adults by promoting timely and effective osteoporosis treatment.

How similar studies have performed: Other studies have shown success with similar multifaceted interventions focusing on education and shared decision-making in managing osteoporosis.

Eligibility criteria

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.

Where this trial is running

Changsha and 6 other locations

• The Second Affiliated Hospital of Hunan University of Chinese Medicine — Changsha, China (Recruiting)
• Dongguan Eighth People's Hospital — Dongguan, China (Recruiting)
• Third Affiliated Hospital, Sun Yat-sen University — Guangzhou, China (Recruiting)
• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, China (Recruiting)
• The First People's Hospital of Hefei — Hefei, China (Recruiting)
• Longgang Orthopedics Hospital of Shenzhen — Shenzhen, China (Recruiting)
• The Third People's Hospital of Longgang District Shenzhen — Shenzhen, China (Recruiting)

Study contacts

• Principal investigator: Jian Mo, MD — Third Affiliated Hospital, Sun Yat-Sen University
• Study coordinator: Jian Mo, MD

Conditions Fragility Fracture; Osteoporosis; Shared Decision-Making; Education