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

NCT04709393 | Active Not Recruiting DMC

• 1 other identifier: 2020.609-T
• Study Type: interventional
• Target: 2,956
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Age Related Osteoporosis; Fall

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Rate of receiving osteoporosis screening

  6-12 months

• rate of receiving fall risk assessment

  6-12 months

• rate of receiving anti-osteoporosis intervention

  6-12 months

• rate of receiving fall prevention intervention

  6-12 months

• subsequent fall rate

  12 months

Study Arms (2)

Pre-screening

EXPERIMENTAL

Receiving FRAX+SARC-F questionnaire pre-screening results on estimated fracture risk

Other: FRAX+SARC-F questionnaire pre-screening

Control

NO INTERVENTION

Not receiving FRAX+SARC-F questionnaire pre-screening preliminary results on estimated fracture risk

Interventions

FRAX+SARC-F questionnaire pre-screening OTHER

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.

Pre-screening

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• aged ≥ 65 years
• living in the community

You may not qualify if:

• cannot follow the instruction

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Timothy Kwok

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 14, 2021
• Study Start: May 7, 2021
• Primary Completion: December 30, 2023
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

HK (1)