Age Related OsteoporosisNCT04709393
Effects of FRAX+SARC-F Pre-screening on Preventing Fragility Fracture and Fall in Community-dwelling Older Adults
A study testing FRAX+SARC-F questionnaire pre-screening in people with Age Related Osteoporosis and Fall, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age Related Osteoporosis, Fall
- What is being tested?
- FRAX+SARC-F questionnaire pre-screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,956 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 May 2021to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged ≥ 65 years
- living in the community
Who cannot join
- cannot follow the instruction
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control
Hong Kong
About this study
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
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.
Read the 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
- Being tested
- FRAX+SARC-F questionnaire pre-screening
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRAX+SARC-F questionnaire pre-screeningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-screening | Experimental | Receiving FRAX+SARC-F questionnaire pre-screening results on estimated fracture risk Receives: Other: FRAX+SARC-F questionnaire pre-screening |
| Control | No intervention | Not receiving FRAX+SARC-F questionnaire pre-screening preliminary results on estimated fracture risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 1-6 months
Secondary outcomes (6)
Rate of receiving osteoporosis screening
Number of participants receiving osteoporosis screening in the arms
Measured: 6-12 months
rate of receiving fall risk assessment
Number of participants receiving fall risk assessment in the arms
Measured: 6-12 months
rate of receiving anti-osteoporosis intervention
Number of participants receiving anti-osteoporosis intervention in the arms
Measured: 6-12 months
rate of receiving fall prevention intervention
Number of participants receiving fall prevention intervention in the arms
Measured: 6-12 months
subsequent fall rate
Number of participants having subsequent fall in the arms
Measured: 12 months
subsequent fracture rate
Number of participants having subsequent fracture in the arms
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start7 May 2021
- Primary completion30 Dec 2023
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related OsteoporosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,956 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Kwok, Chinese University of Hong Kong
- Investigators
- Timothy Kwok, Principal investigator, The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709393
- Sponsor's protocol ID
- 2020.609-T
- Status last verified
- Aug 2024
- First submitted
- 13 Jan 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04709393
- Acronym / sponsor ID
- 2020.609-T
- Conditions
- Age Related Osteoporosis, Fall
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,956 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-screening | Experimental | Other: FRAX+SARC-F questionnaire pre-screeningReceiving FRAX+SARC-F questionnaire pre-screening results on estimated fracture risk |
| Control | No intervention | –Not receiving FRAX+SARC-F questionnaire pre-screening preliminary results on estimated fracture risk |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- aged ≥ 65 years
- living in the community
Key exclusion criteria (1 listed)
- cannot follow the instruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FRAX+SARC-F questionnaire pre-screeningPre-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. | Other | Pre-screening |
Primary outcome
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.
6 secondary outcomes
Rate of receiving osteoporosis screening
Time frame: 6-12 months
rate of receiving fall risk assessment
Time frame: 6-12 months
rate of receiving anti-osteoporosis intervention
Time frame: 6-12 months
rate of receiving fall prevention intervention
Time frame: 6-12 months
subsequent fall rate
Time frame: 12 months
subsequent fracture rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Kwok principal investigator
The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRAX+SARC-F questionnaire pre-screening in people with Age Related Osteoporosis and Fall, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportions of participants diagnosed with osteoporosis in the FRAX+SARC-F pre-screening and control groups. (time frame: within 1-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.