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NCT Number: NCT04709393

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hong Kong

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged ≥ 65 years
  • living in the community

Exclusion criteria

  • cannot follow the instruction

Treatment and study plan

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.

Primary outcomes

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

    Time frame: within 1-6 months

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

Secondary outcomes

  1. Rate of receiving osteoporosis screening

    Time frame: 6-12 months

    Number of participants receiving osteoporosis screening in the arms

  2. rate of receiving fall risk assessment

    Time frame: 6-12 months

    Number of participants receiving fall risk assessment in the arms

  3. rate of receiving anti-osteoporosis intervention

    Time frame: 6-12 months

    Number of participants receiving anti-osteoporosis intervention in the arms

  4. rate of receiving fall prevention intervention

    Time frame: 6-12 months

    Number of participants receiving fall prevention intervention in the arms

  5. subsequent fall rate

    Time frame: 12 months

    Number of participants having subsequent fall in the arms

  6. subsequent fracture rate

    Time frame: 12 months

    Number of participants having subsequent fracture in the arms

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2028
First posted
Jan 14, 2021
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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