Effects of FRAX+SARC-F Pre-screening on Preventing Fragility Fracture and Fall in Community-dwelling Older Adults

Fall Clinical Trial

Official title:

The Effects of FRAX+SARC-F Questionnaire Pre-screening on Promoting Public Awareness of Fragility Fracture and Fall Prevention Among Community-dwelling Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04709393
• Other study ID #: 2020.609-T
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2021
• Est. completion date: December 2028

Study information

• Verified date: October 2022
• Source: Chinese University of Hong Kong
• Contact: Postdoctoral Fellow
• Phone: (852) 2252 8894
• Email: c.tsang[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hip fragility fractures are a major threat to functional independence in older adults locally and globally. In Hong Kong, the prevalence of osteoporosis and osteopenia in people aged >50 years were reported to be as high as 37% and 52%, respectively. The major challenge in fragility fracture prevention is that fragility fracture is caused by the combination of osteoporosis and propensity to fall, and both of these conditions are multifactorial. Ample evidence shows that fall risks can be reduced by well-designed exercises, and osteoporosis can be effectively diagnosed by Dual-energy X-ray Absorptiometry imaging (DXA) and treated with anti-osteoporosis medication. Lifestyle modifications e.g. diet, optimal physical activity, environmental safety can also help to prevent falls or improve bone health. The brief Fracture Risk Assessment Tool (FRAX) and SARC-F provide a low cost of prescreening for fracture risk and sarcopenia, respectively. Using SARC-F in conjunction with FRAX has increased sensitivity for hip fracture risk prediction. FRAX+SARC-F may help increase the public awareness of osteoporosis and get the at-risk group to receive diagnostic tests and be treated. This model should fit in well with the coming District Health Centres across Hong Kong.

Description:

Participants will be randomly assigned to either the pre-screening or control group in a 1:1 ratio. Independent personnel not involved in data collection or intervention will perform and conceal the randomization using an online data server. Research assistants who are blinded to the group allocation will conduct all the baseline assessments and subsequent event surveillance. All data will also be entered and checked by the blinded research assistants. All procedures concur with the Declaration of Helsinki (2013).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2956
• Est. completion date: December 2028
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• aged = 65 years
• living in the community

Exclusion Criteria:

• cannot follow the instruction

Related Conditions & MeSH terms

• Age Related Osteoporosis
• Fall
• Osteoporosis

Intervention

Other:
• FRAX+SARC-F questionnaire pre-screening
Pre-screening group participants will receive the FRAX+SARC-F questionnaire pre-screening and be notified of the preliminary estimation of their future hip fracture risk before being invited to our DXA screening and fall-risk assessment.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportions of participants diagnosed with osteoporosis in the FRAX+SARC-F pre-screening and control groups.	proportions of participants diagnosed with osteoporosis in the FRAX+SARC-F pre-screening and control groups.	within 1-6 months
Secondary	Rate of receiving osteoporosis screening	Number of participants receiving osteoporosis screening in the arms	6-12 months
Secondary	rate of receiving fall risk assessment	Number of participants receiving fall risk assessment in the arms	6-12 months
Secondary	rate of receiving anti-osteoporosis intervention	Number of participants receiving anti-osteoporosis intervention in the arms	6-12 months
Secondary	rate of receiving fall prevention intervention	Number of participants receiving fall prevention intervention in the arms	6-12 months
Secondary	subsequent fall rate	Number of participants having subsequent fall in the arms	12 months
Secondary	subsequent fracture rate	Number of participants having subsequent fracture in the arms	12 months