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

Primary Purpose

Age Related Osteoporosis, Fall

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
FRAX+SARC-F questionnaire pre-screening
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Age Related Osteoporosis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • aged ≥ 65 years
  • living in the community

Exclusion Criteria:

• cannot follow the instruction

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pre-screening

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of receiving osteoporosis screening
Number of participants receiving osteoporosis screening in the arms
rate of receiving fall risk assessment
Number of participants receiving fall risk assessment in the arms
rate of receiving anti-osteoporosis intervention
Number of participants receiving anti-osteoporosis intervention in the arms
rate of receiving fall prevention intervention
Number of participants receiving fall prevention intervention in the arms
subsequent fall rate
Number of participants having subsequent fall in the arms
subsequent fracture rate
Number of participants having subsequent fracture in the arms

Full Information

First Posted
January 13, 2021
Last Updated
October 5, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04709393
Brief Title
Effects of FRAX+SARC-F Pre-screening on Preventing Fragility Fracture and Fall in Community-dwelling Older Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Osteoporosis, Fall

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2956 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-screening
Arm Type
Experimental
Arm Description
Receiving FRAX+SARC-F questionnaire pre-screening results on estimated fracture risk
Arm Title
Control
Arm Type
No Intervention
Arm Description
Not receiving FRAX+SARC-F questionnaire pre-screening preliminary results on estimated fracture risk
Intervention Type
Other
Intervention Name(s)
FRAX+SARC-F questionnaire pre-screening
Intervention Description
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.
Primary Outcome Measure Information:
Title
proportions of participants diagnosed with osteoporosis in the FRAX+SARC-F pre-screening and control groups.
Description
proportions of participants diagnosed with osteoporosis in the FRAX+SARC-F pre-screening and control groups.
Time Frame
within 1-6 months
Secondary Outcome Measure Information:
Title
Rate of receiving osteoporosis screening
Description
Number of participants receiving osteoporosis screening in the arms
Time Frame
6-12 months
Title
rate of receiving fall risk assessment
Description
Number of participants receiving fall risk assessment in the arms
Time Frame
6-12 months
Title
rate of receiving anti-osteoporosis intervention
Description
Number of participants receiving anti-osteoporosis intervention in the arms
Time Frame
6-12 months
Title
rate of receiving fall prevention intervention
Description
Number of participants receiving fall prevention intervention in the arms
Time Frame
6-12 months
Title
subsequent fall rate
Description
Number of participants having subsequent fall in the arms
Time Frame
12 months
Title
subsequent fracture rate
Description
Number of participants having subsequent fracture in the arms
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged ≥ 65 years living in the community Exclusion Criteria: • cannot follow the instruction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Postdoctoral Fellow
Phone
(852) 2252 8894
Email
c.tsang@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Kwok
Organizational Affiliation
The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Postdoctoral Fellow

12. IPD Sharing Statement

Learn more about this trial

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

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