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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05104034
• Collaborator: National Health Research Institutes, Taiwan (Other)
• Enrollment: 600
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 49.3
• Patients Per Site Per Month: 12.2

Study Details

Study Description

Brief 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. 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

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis; Sarcopenia	Behavioral: Osteoporosis and sarcopenia screening	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Comprehensive Risk Assessment and Prevention Plan of Osteoporosis and Sarcopenia for the Elderly Participating in Community-based Long-term Care Services
• Anticipated Study Start Date: Nov 20, 2021
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Osteoporosis and sarcopenia screening; Use DXA, BIA, and questionnaire to screen the community elderly
Experimental: Multi-discipline intervention Introduce integrated services of health education, nutrition, rehabilitation, medication evaluation and other multi-specialties to assist study participants with health promotion	Behavioral: Osteoporosis and sarcopenia screening; Use DXA, BIA, and questionnaire to screen the community elderly
Placebo Comparator: 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.	Behavioral: Osteoporosis and sarcopenia screening; Use DXA, BIA, and questionnaire to screen the community elderly

Outcome Measures

Primary Outcome Measures

1. Osteoporosis diagnosis rate [one year]

   To define if the osteoporosis diagnosis rate would be changed

Secondary Outcome Measures

1. Osteoporosis treatment rate [one year]

   To define if the osteoporosis treatment rate would be changed

2. Sarcopenia diagnosis rate [one year]

   To define if the Sarcopenia diagnosis rate would be changed

3. Incidence of fall [two year]

   To define if the fall frequency would be changed

Other Outcome Measures

1. Incidence of fracture [four year]

   To define if the Incidence of fracture would be changed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age≥ 50 old and lived in the community

Exclusion Criteria:

• Life expectancy less than two years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital, Yunlin branch	Douliu	Yunlin County	Taiwan

Sponsors and Collaborators

• National Taiwan University Hospital
• National Health Research Institutes, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT05104034
• Other Study ID Numbers: 202106076RIND
• First Posted: Nov 2, 2021
• Last Update Posted: Nov 2, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Taiwan University Hospital: Osteoporosis; Sarcopenia
• Additional relevant MeSH terms: Osteoporosis; Sarcopenia

Study Results

No Results Posted as of Nov 2, 2021