AzTrials
AzTrials

Osteoporosis or OsteopeniaNCT00173693

What is the Best Policy to Prevent Osteoporotic Fracture?

A study testing exercise for strength, balance, health education in people with Osteoporosis or Osteopenia, run by National Taiwan University Hospital at 1 site in Taiwan.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Osteoporosis or Osteopenia
What is being tested?
exercise for strength, balance, health education
How many people
0 participants
Where
1 siteTaiwan
Study dates
Jan 2006to Dec 2010
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • post menopausal women or male over 65 y/o

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

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
  4. To calculate the cost of three intervention programs (from the view of provider).
  5. Telephone follow-up (FU) and recording the incidence of fall \& fracture every 3 months.
  6. The first FU (1st FU) of the items collected at baseline.
  7. To study the medical cost of osteoporotic fracture with NHRI data. Fourth year (2009): continuing follow-up and study on QOL <!-- -->
  8. Continuing the telephone FU and recording the incidence of fall \& fracture every 3 months
  9. The second FU (2nd FU) of the items collected at baseline
  10. 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
  11. Continuing the telephone FU and recording the incidence of fall \& fracture every 3 months.
  12. The third FU (3rd F/U) of the items collected at baseline.
  13. To investigate the effects of each intervention program
Being tested
exercise for strength, balance, health education
Keywords
CEA, Osteoporosis, Fracture, Prevention, Exercise
Medical subject headings
Osteoporosis, Bone Diseases, Metabolic, Fractures, Bone, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exercise for strength, balance, health educationBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone mineral density, osteoporotic fracture

Secondary outcomes (1)
  1. CEA, Osteoporosis, Fracture, Prevention, Exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startJan 2006
  3. Study completionDec 2010 (estimated)

Resources

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
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00173693
Sponsor's protocol ID
9461700347
Status last verified
Nov 2012
First submitted
12 Sep 2005
Last updated
10 Dec 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing exercise for strength, balance, health education in people with Osteoporosis or Osteopenia, 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: withdrawn, as of the sponsor's last update on 10 Dec 2012. 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. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone mineral density, osteoporotic fracture. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Dec 2012.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in