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

NCT ID: NCT04709393

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2956 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-07
• Study Completion Date: 2028-12-31

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).

Conditions

Age Related Osteoporosis; Fall

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Pre-screening

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

Group Type: EXPERIMENTAL

FRAX+SARC-F questionnaire pre-screening

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• aged ≥ 65 years
• living in the community

Exclusion Criteria

• cannot follow the instruction

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Timothy Kwok

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy Kwok

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

2020.609-T

Identifier Type: -

Identifier Source: org_study_id