What is the Best Policy to Prevent Osteoporotic Fracture?
NCT ID: NCT00173693
Last Updated: 2012-12-10
Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2006-01-31
2010-12-31
Brief Summary
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Detailed Description
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First year (2006): mainly a preparation stage
1. To conduct a meta-analysis of the effects of various interventions of prevention of osteoporotic fracture, especially in exercise models.
2. To establish the exercise programs for the intervention in the 2nd year, including the booklets and the posters.
3. To review the other alternatives of prevention of osteoporotic fracture.
4. To establish the social network needed for the following research. Second year (2007): to start the community-based field studies in Neihu District, Taipei.
All 37 "Lis" in Neihu will be invited to join the study, but only the Lis with willingness of participation will be the units for cluster sampling, and will be randomized to the three programs (Li as a unit). People living in the sampled Lis meet the inclusion criteria (postmenopausal (minimum for 1year) women and men over 65 years old) will be recruited and they will be further randomized into intervention group or reference group within each program.
1.To collect the baseline data. Baseline data include: the BMD, physical activity, nutrition diary, muscle strength, balance, risk factors of osteoporosis, history of fractures and falls 2.To execute the interventions. Three programs will be executed in the sampled Lis. They are all designed as a randomized control trial.
1. Health education (HE trial): lectures on knowledge of osteoporosis, osteoporotic fracture, the risk factors, the nutritional demand, the exercise principles for enhancing BMD and preventing fall.
2. Intervention for enhancing BMD (BMD trial): interventions to emphasize on weight-bearing exercise and trunk stabilization exercises. The exercise program will be supervised by a professional physical therapist 3 times per week for 3 months.
3. Intervention for preventing falls (fall prevention trial): interventions to emphasize on balance and strength training exercises. The exercise program will be also supervised by a professional physical therapist 3 times per week for 3 months.
3.To apply the NHRI released health insurance data (2002-2006) for the next year study Third year (2008): follow-up, cost calculation and study on medical cost
1. To calculate the cost of three intervention programs (from the view of provider).
2. Telephone follow-up (FU) and recording the incidence of fall \& fracture every 3 months.
3. The first FU (1st FU) of the items collected at baseline.
4. To study the medical cost of osteoporotic fracture with NHRI data. Fourth year (2009): continuing follow-up and study on QOL
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1. Continuing the telephone FU and recording the incidence of fall \& fracture every 3 months
2. The second FU (2nd FU) of the items collected at baseline
3. To conduct a survey for the health-related QOL of people with osteoporotic fracture from outpatient clinics in hospital and the newly fractured subjects in the community.
Fifth year (2010): continuing follow-up and CEA
1. Continuing the telephone FU and recording the incidence of fall \& fracture every 3 months.
2. The third FU (3rd F/U) of the items collected at baseline.
3. To investigate the effects of each intervention program
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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exercise for strength, balance, health education
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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J Y Tsauo, PhD
Role: STUDY_DIRECTOR
Grad School of PT, College of Medicine, NTU
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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9461700347
Identifier Type: -
Identifier Source: org_study_id