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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fall; Age Related Osteoporosis
• Intervention / Treatment: Other: FRAX+SARC-F questionnaire pre-screening

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 2956
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• aged ≥ 65 years
• living in the community

Exclusion Criteria:

• cannot follow the instruction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-screening; Receiving FRAX+SARC-F questionnaire pre-screening results on estimated fracture risk	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.
No Intervention: Control; Not receiving FRAX+SARC-F questionnaire pre-screening preliminary results on estimated fracture risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of receiving osteoporosis screening	Number of participants receiving osteoporosis screening in the arms	6-12 months
rate of receiving fall risk assessment	Number of participants receiving fall risk assessment in the arms	6-12 months
rate of receiving anti-osteoporosis intervention	Number of participants receiving anti-osteoporosis intervention in the arms	6-12 months
rate of receiving fall prevention intervention	Number of participants receiving fall prevention intervention in the arms	6-12 months
subsequent fall rate	Number of participants having subsequent fall in the arms	12 months
subsequent fracture rate	Number of participants having subsequent fracture in the arms	12 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Timothy Kwok, The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2021
• Primary Completion (Actual): December 30, 2023
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: 2020.609-T

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No