Clinical trial NCT04709393: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Age Related Osteoporosis
Fall
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 2956
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria:

* aged ≥ 65 years
* living in the community

Exclusion Criteria:

• cannot follow the instruction

Primary outcomes:
measure: proportions of participants diagnosed with osteoporosis in the FRAX+SARC-F pre-screening and control groups.
timeFrame: within 1-6 months
Secondary outcomes:
measure: Rate of receiving osteoporosis screening
timeFrame: 6-12 months
measure: rate of receiving fall risk assessment
timeFrame: 6-12 months
measure: rate of receiving anti-osteoporosis intervention
timeFrame: 6-12 months
measure: rate of receiving fall prevention intervention
timeFrame: 6-12 months
measure: subsequent fall rate
timeFrame: 12 months
measure: subsequent fracture rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control
Study officials:
affiliation: The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control
name: Timothy Kwok
role: PRINCIPAL_INVESTIGATOR
References: