Comprehensive Risk Assessment and Prevention Plan of Osteoporosis and Sarcopenia for the Elderly Participating in Community-based Long-term Care Services

NCT ID: NCT05104034

Last Updated: 2024-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-17

Study Completion Date

2025-12-31

Brief Summary

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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. 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
3. Construct a pragmatic and integrated care service model for osteoporosis and sarcopenia in the elderly people from rural areas

Detailed Description

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Detailed Description:

Investigators plan to use a stepped-wedge cluster randomized trial that allocates participants into the following three groups:

1. 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.
2. 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.
3. 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

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Osteoporosis Sarcopenia Frailty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Osteoporosis screening and treatment as needed

Intervention Type BEHAVIORAL

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.

Multi-component integrated intervention

Introduce integrated services of health education, nutrition, rehabilitation, pharmaceutical care, and other multi-specialties to assist study participants with health promotion

Group Type EXPERIMENTAL

Osteoporosis screening and treatment as needed

Intervention Type BEHAVIORAL

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.

Sarcopenia

Intervention Type BEHAVIORAL

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.

Exercise

Intervention Type BEHAVIORAL

TheraBand (resistance band) was utilized as the exercise tool within the community. T

Nutrition

Intervention Type DIETARY_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 care

Intervention Type BEHAVIORAL

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.

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.

Group Type PLACEBO_COMPARATOR

Osteoporosis screening and treatment as needed

Intervention Type BEHAVIORAL

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.

Interventions

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Osteoporosis screening and treatment as needed

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.

Intervention Type BEHAVIORAL

Sarcopenia

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.

Intervention Type BEHAVIORAL

Exercise

TheraBand (resistance band) was utilized as the exercise tool within the community. T

Intervention Type BEHAVIORAL

Nutrition

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.

Intervention Type DIETARY_SUPPLEMENT

Pharmaceutical care

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age≥ 50 old and lived in the community

Exclusion Criteria

* Life expectancy less than two years
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Health Research Institutes, Taiwan

OTHER

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital, Yunlin branch

Douliu, Yunlin County, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shau-Huai Fu, Doctor

Role: CONTACT

+886972655734

Chen-Yu Wang, Doctor

Role: CONTACT

+886952489782

Facility Contacts

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Shau-Huai Fu, Doctor

Role: primary

+886972655734

Chen-Yu Wang, Doctor

Role: backup

+886952489782

References

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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.

Reference Type DERIVED
PMID: 39875677 (View on PubMed)

Other Identifiers

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202106076RIND

Identifier Type: -

Identifier Source: org_study_id

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