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

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT04709393
Collaborator
(none)
2,956
1
2
90.8
32.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: FRAX+SARC-F questionnaire pre-screening
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
2956 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
May 7, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 1, 2028

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. proportions of participants diagnosed with osteoporosis in the FRAX+SARC-F pre-screening and control groups. [within 1-6 months]

    proportions of participants diagnosed with osteoporosis in the FRAX+SARC-F pre-screening and control groups.

Secondary Outcome Measures

  1. Rate of receiving osteoporosis screening [6-12 months]

    Number of participants receiving osteoporosis screening in the arms

  2. rate of receiving fall risk assessment [6-12 months]

    Number of participants receiving fall risk assessment in the arms

  3. rate of receiving anti-osteoporosis intervention [6-12 months]

    Number of participants receiving anti-osteoporosis intervention in the arms

  4. rate of receiving fall prevention intervention [6-12 months]

    Number of participants receiving fall prevention intervention in the arms

  5. subsequent fall rate [12 months]

    Number of participants having subsequent fall in the arms

  6. subsequent fracture rate [12 months]

    Number of participants having subsequent fracture in the arms

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • aged ≥ 65 years

  • living in the community

Exclusion Criteria:

• cannot follow the instruction

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control Hong Kong Hong Kong

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Timothy Kwok, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04709393
Other Study ID Numbers:
  • 2020.609-T
First Posted:
Jan 14, 2021
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2021