OsteoporosisNCT05104034
Comprehensive Risk Assessment and Prevention Plan of Osteoporosis and Sarcopenia for the Elderly Participating in Community-based Long-term Care Services
A study testing Osteoporosis screening and treatment as needed, Sarcopenia and Exercise in people with Osteoporosis and Sarcopenia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this project is: 1. Provide the epidemiological data of the prevalence, incidence, and risk factors of osteoporosis and sarcopenia among the elderly in rural areas. 2. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Sarcopenia, Frailty
- What is being tested?
- Osteoporosis screening and treatment as needed, Sarcopenia and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Sep 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age≥ 50 old and lived in the community
Who cannot join
- Life expectancy less than two years
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital, Yunlin branch
Douliu, Yunlin County
Shau-Huai Fu, Doctor, +886972655734, b90401045@gmail.com
Chen-Yu Wang, Doctor, +886952489782, valinawang0220@gmail.com
About this study
The purpose of this project is:
- Provide the epidemiological data of the prevalence, incidence, and risk factors of osteoporosis and sarcopenia among the elderly in rural areas.
- Screen osteoporosis and sarcopenia among the elderly and provide with assistance for following care in order to improve the diagnosis and treatment rates of osteoporosis and sarcopenia
- Construct a pragmatic and integrated care service model for osteoporosis and sarcopenia in the elderly people from rural areas
Read the detailed description
Detailed Description:
Investigators plan to use a stepped-wedge cluster randomized trial that allocates participants into the following three groups:
- Screening group: Inform the elderly about the results of the screening and recommend those with moderate to high risk of fracture to receive active examination and treatment.
- Multi-disciplinary team intervention group: Introduce integrated services of health education, nutrition, rehabilitation, medication evaluation and other multi-specialties to assist study participants with health promotion.
- Control group (Delayed intervention): receive general care after collecting basic information, and provide health education related information such as osteoporosis sarcopenia. After two year's follow-up, multi-disciplinary team intervention service will be implemented.
- Conditions
- Osteoporosis, Sarcopenia, Frailty
- Being tested
- Osteoporosis screening and treatment as needed, Sarcopenia, Exercise, Nutrition, Pharmaceutical care
- Keywords
- Osteoporosis, Sarcopenia, Quality of life, Intrinsic capacity, Frailty
- Medical subject headings
- Osteoporosis, Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteoporosis screening and treatment as neededBehavioural
All residents underwent screening using the Fracture Risk Assessment Tool (FRAX) and Mobile dual-energy X-ray absorptiometry (DXA) (Horizon Wi, Hologic Inc., Bedford, MA). Our study nurses actively assisted osteoporosis treatment if indicated.
SarcopeniaBehavioural
Sarcopenia assessment adhered to the 2019 Consensus Update on Sarcopenia Diagnosis and Treatment by the Asian Working Group for Sarcopenia guideline. Following screening, individuals identified with sarcopenia underwent tailored interventions involving exercise and nutrition as deemed necessary.
ExerciseBehavioural
TheraBand (resistance band) was utilized as the exercise tool within the community. T
NutritionDietary supplement
Nutrition Nutritional education programs aim to increase protein food serving and the choice of those with insufficient dietary intake. Protein supplement was added if indicated.
Pharmaceutical careBehavioural
We collected drug information of the elderly. Detailed and real-time prescription drug information was retrieved from the National Health Insurance PharmaCloud System. A pharmaceutical care team performed patient-centered drug review and discussion every three to six months.
| Study group | Role | What they receive |
|---|---|---|
| Screening group | Experimental | Inform the elderly about the results of the screening and recommend those with moderate to high risk of fracture to receive active examination and treatment. Receives: Behavioral: Osteoporosis screening and treatment as needed |
| Multi-component integrated intervention | Experimental | Introduce integrated services of health education, nutrition, rehabilitation, pharmaceutical care, and other multi-specialties to assist study participants with health promotion Receives: Behavioral: Osteoporosis screening and treatment as needed; Behavioral: Sarcopenia; Behavioral: Exercise; Dietary Supplement: Nutrition; Behavioral: Pharmaceutical care |
| Delayed intervention | Placebo comparator | receive general care after collecting basic information, and provide health education related information such as osteoporosis sarcopenia. After two year's follow-up, multi-disciplinary team intervention service will be implemented. Receives: Behavioral: Osteoporosis screening and treatment as needed |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of Quality of life and quality adjusted life year
Using EQ5D / WHOQOL Brief questionnaires to measure quality of life and evaluate the changes after intervention. In addition, to calculate quality adjusted life year by using utility index derived from qualify of life measurement.
Measured: one year, two year, 3 year, four year
Intrinsic capacity
To define if the Intrinsic capacity would be changed after intervention
Measured: one year, two year, 3 year, four year
Institutionalilzation rate
To define if the Institutionalilzation rate would be changed after intervention
Measured: one year, two year, 3 year, four year
Secondary outcomes (3)
Incidence of fall
To define if the fall frequency would be changed after intervention
Measured: one year, two year, 3 year, four year
Incidence of fracture
To define if the incidence of fracture would be changed after intervention
Measured: one year, two year, 3 year, four year
Incidence of unexpected hospitalization
To define if the unexpected hospitalization would be changed after intervention
Measured: one year, two year, 3 year, four year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start17 Sep 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104034
- Sponsor's protocol ID
- 202106076RIND
- Status last verified
- Sep 2023
- First submitted
- 11 Oct 2021
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fu SH, Lai WJ, Yen HK, Kukreti S, Li CY, Hung CC, Wang CY. Addressing healthcare disparities and improving osteoporosis management in rural communities: a cluster randomized control trial. Arch Osteoporos. 2025 Jan 28;20(1):15. doi: 10.1007/s11657-025-01498-4.
PubMed 39875677
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Risk Assessment and Prevention Plan of Osteoporosis and Sarcopenia for the Elderly Participating in Community-based Long-term Care Services
- ClinicalTrials.gov ID
- NCT05104034
- Acronym / sponsor ID
- 202106076RIND
- Conditions
- Osteoporosis, Sarcopenia, Frailty
- Keywords
- Osteoporosis, Sarcopenia, Quality of life, Intrinsic capacity, Frailty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Nov 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.
The purpose of this project is:
- Provide the epidemiological data of the prevalence, incidence, and risk factors of osteoporosis and sarcopenia among the elderly in rural areas.
- Screen osteoporosis and sarcopenia among the elderly and provide with assistance for following care in order to improve the diagnosis and treatment rates of osteoporosis and sarcopenia
- Construct a pragmatic and integrated care service model for osteoporosis and sarcopenia in the elderly people from rural areas
Detailed description
Detailed Description:
Investigators plan to use a stepped-wedge cluster randomized trial that allocates participants into the following three groups:
- Screening group: Inform the elderly about the results of the screening and recommend those with moderate to high risk of fracture to receive active examination and treatment.
- Multi-disciplinary team intervention group: Introduce integrated services of health education, nutrition, rehabilitation, medication evaluation and other multi-specialties to assist study participants with health promotion.
- Control group (Delayed intervention): receive general care after collecting basic information, and provide health education related information such as osteoporosis sarcopenia. After two year's follow-up, multi-disciplinary team intervention service will be implemented.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Screening group | Experimental | Behavioral: Osteoporosis screening and treatment as neededInform the elderly about the results of the screening and recommend those with moderate to high risk of fracture to receive active examination and treatment. |
| Multi-component integrated intervention | Experimental | Behavioral: Osteoporosis screening and treatment as needed, Behavioral: Sarcopenia, Behavioral: Exercise, Dietary Supplement: Nutrition, Behavioral: Pharmaceutical careIntroduce integrated services of health education, nutrition, rehabilitation, pharmaceutical care, and other multi-specialties to assist study participants with health promotion |
| Delayed intervention | Placebo comparator | Behavioral: Osteoporosis screening and treatment as neededreceive general care after collecting basic information, and provide health education related information such as osteoporosis sarcopenia. After two year's follow-up, multi-disciplinary team intervention service will be implemented. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age≥ 50 old and lived in the community
Key exclusion criteria (1 listed)
- Life expectancy less than two years
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 |
|---|---|---|
| Osteoporosis screening and treatment as neededAll residents underwent screening using the Fracture Risk Assessment Tool (FRAX) and Mobile dual-energy X-ray absorptiometry (DXA) (Horizon Wi, Hologic Inc., Bedford, MA). Our study nurses actively assisted osteoporosis treatment if indicated. | Behavioural | Delayed intervention, Multi-component integrated intervention, Screening group |
| SarcopeniaSarcopenia assessment adhered to the 2019 Consensus Update on Sarcopenia Diagnosis and Treatment by the Asian Working Group for Sarcopenia guideline. Following screening, individuals identified with sarcopenia underwent tailored interventions involving exercise and nutrition as deemed necessary. | Behavioural | Multi-component integrated intervention |
| ExerciseTheraBand (resistance band) was utilized as the exercise tool within the community. T | Behavioural | Multi-component integrated intervention |
| NutritionNutrition Nutritional education programs aim to increase protein food serving and the choice of those with insufficient dietary intake. Protein supplement was added if indicated. | Dietary supplement | Multi-component integrated intervention |
| Pharmaceutical careWe collected drug information of the elderly. Detailed and real-time prescription drug information was retrieved from the National Health Insurance PharmaCloud System. A pharmaceutical care team performed patient-centered drug review and discussion every three to six months. | Behavioural | Multi-component integrated intervention |
Primary outcome
The changes of Quality of life and quality adjusted life year
Time frame: one year, two year, 3 year, four year
Using EQ5D / WHOQOL Brief questionnaires to measure quality of life and evaluate the changes after intervention. In addition, to calculate quality adjusted life year by using utility index derived from qualify of life measurement.
Intrinsic capacity
Time frame: one year, two year, 3 year, four year
To define if the Intrinsic capacity would be changed after intervention
Institutionalilzation rate
Time frame: one year, two year, 3 year, four year
To define if the Institutionalilzation rate would be changed after intervention
3 secondary outcomes
Incidence of fall
Time frame: one year, two year, 3 year, four year
Incidence of fracture
Time frame: one year, two year, 3 year, four year
Incidence of unexpected hospitalization
Time frame: one year, two year, 3 year, four year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Derived from this study: PubMed 39875677Fu SH, Lai WJ, Yen HK, Kukreti S, Li CY, Hung CC, Wang CY. Addressing healthcare disparities and improving osteoporosis management in rural communities: a cluster randomized control trial. Arch Osteoporos. 2025 Jan 28;20(1):15. doi: 10.1007/s11657-025-01498-4.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteoporosis screening and treatment as needed, Sarcopenia and Exercise in people with Osteoporosis and Sarcopenia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 15 Apr 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shau-Huai Fu, Doctor (+886972655734, b90401045@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of Quality of life and quality adjusted life year (time frame: one year, two year, 3 year, four year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05104034, which also lists 1 linked publication.
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 15 Apr 2024.