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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
- To conduct a meta-analysis of the effects of various interventions of prevention of osteoporotic fracture, especially in exercise models.
- To establish the exercise programs for the intervention in the 2nd year, including the booklets and the posters.
- To review the other alternatives of prevention of osteoporotic fracture.
- 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.
- 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.
- 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.
- 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
- To calculate the cost of three intervention programs (from the view of provider).
- Telephone follow-up (FU) and recording the incidence of fall \& fracture every 3 months.
- The first FU (1st FU) of the items collected at baseline.
- To study the medical cost of osteoporotic fracture with NHRI data. Fourth year (2009): continuing follow-up and study on QOL <!-- -->
- Continuing the telephone FU and recording the incidence of fall \& fracture every 3 months
- The second FU (2nd FU) of the items collected at baseline
- 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
- Continuing the telephone FU and recording the incidence of fall \& fracture every 3 months.
- The third FU (3rd F/U) of the items collected at baseline.
- To investigate the effects of each intervention program
- Conditions
- Osteoporosis or Osteopenia
- 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.
Bone mineral density, osteoporotic fracture
Secondary outcomes (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.
- First posted15 Sep 2005 (estimated)
- Study startJan 2006
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis or OsteopeniaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J Y Tsauo, PhD, Study director, Grad School of PT, College of Medicine, NTU
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Best Policy to Prevent Osteoporotic Fracture?
- ClinicalTrials.gov ID
- NCT00173693
- Acronym / sponsor ID
- 9461700347
- Conditions
- Osteoporosis or Osteopenia
- Keywords
- CEA, Osteoporosis, Fracture, Prevention, Exercise
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Dec 2010 (estimated)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- To conduct a meta-analysis of the effects of various interventions of prevention of osteoporotic fracture, especially in exercise models.
- To establish the exercise programs for the intervention in the 2nd year, including the booklets and the posters.
- To review the other alternatives of prevention of osteoporotic fracture.
- 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.
- 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.
- 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.
- 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
- To calculate the cost of three intervention programs (from the view of provider).
- Telephone follow-up (FU) and recording the incidence of fall \& fracture every 3 months.
- The first FU (1st FU) of the items collected at baseline.
- To study the medical cost of osteoporotic fracture with NHRI data. Fourth year (2009): continuing follow-up and study on QOL <!-- -->
- Continuing the telephone FU and recording the incidence of fall \& fracture every 3 months
- The second FU (2nd FU) of the items collected at baseline
- 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
- Continuing the telephone FU and recording the incidence of fall \& fracture every 3 months.
- The third FU (3rd F/U) of the items collected at baseline.
- To investigate the effects of each intervention program
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- post menopausal women or male over 65 y/o
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise for strength, balance, health education | Behavioural | – |
Primary outcome
Bone mineral density, osteoporotic fracture
1 secondary outcome
CEA, Osteoporosis, Fracture, Prevention, Exercise
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J Y Tsauo, PhD study director
Grad School of PT, College of Medicine, NTU
1 site in 1 country: see every site and its status.
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.