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WithdrawnNCT00173693Updated Dec 10, 2012

What is the Best Policy to Prevent Osteoporotic Fracture?

An interventional study of exercise for strength, balance, health education in Osteoporosis or Osteopenia, sponsored by National Taiwan University Hospital. Withdrawn at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2012-12-10.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Sex
All
01

Study summary

This study aims to conduct a cost-effectiveness analysis (CEA) among the programs for preventing osteoporotic fracture. The main comparison will be made among the effects of three programs for preventing osteoporotic fractures: 1. health education; 2. exercise intervention for enhancing bone mineral density (BMD); 3. exercise intervention for preventing falls. The "cost" will be measured bases on the monetary cost of implementation of each program. The "effectiveness" will be measured includes the number of prevented osteoporotic fractures of each program, and related outcomes are the follows: 1. the medical cost of osteoporotic fracture; 2. the change of BMD in consecutive years; 3. the quality of life (QOL) of patients with osteoporotic fracture as compared to the reference population.

Read the detailed description

This study aims to conduct a cost-effectiveness analysis (CEA) among the programs for preventing osteoporotic fracture. The main comparison will be made among the effects of three programs for preventing osteoporotic fractures: 1. health education; 2. exercise intervention for enhancing bone mineral density (BMD); 3. exercise intervention for preventing falls. The "cost" will be measured bases on the monetary cost of implementation of each program. The "effectiveness" will be measured includes the number of prevented osteoporotic fractures of each program, and related outcomes are the follows: 1. the medical cost of osteoporotic fracture; 2. the change of BMD in consecutive years; 3. the quality of life (QOL) of patients with osteoporotic fracture as compared to the reference population.

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
02

Conditions studied

  • Osteoporosis or Osteopenia

Keywords

  • CEA, Osteoporosis, Fracture, Prevention, Exercise
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

Browse Osteoporosis studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • post menopausal women or male over 65 y/o

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • Behavioralexercise for strength, balance, health education
06

What researchers measure

Primary outcomes

  1. Bone mineral density, osteoporotic fracture

Secondary outcomes

  1. CEA, Osteoporosis, Fracture, Prevention, Exercise

07

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00173693
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Sep 15, 2005
Start date
Jan 2006
Completion
Dec 2010 (estimated)
Last update
Dec 10, 2012

Study contacts

J Y Tsauo, PhD
study director · Grad School of PT, College of Medicine, NTU
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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