search
Back to results

What is the Best Policy to Prevent Osteoporotic Fracture?

Primary Purpose

Osteoporosis or Osteopenia

Status
Withdrawn
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
exercise for strength, balance, health education
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis or Osteopenia focused on measuring CEA, Osteoporosis, Fracture, Prevention, Exercise

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: post menopausal women or male over 65 y/o Exclusion Criteria: -

Sites / Locations

  • National Taiwan University Hospital

Outcomes

Primary Outcome Measures

Bone mineral density, osteoporotic fracture

Secondary Outcome Measures

CEA, Osteoporosis, Fracture, Prevention, Exercise

Full Information

First Posted
September 12, 2005
Last Updated
December 6, 2012
Sponsor
National Taiwan University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00173693
Brief Title
What is the Best Policy to Prevent Osteoporotic Fracture?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Withdrawn
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis or Osteopenia
Keywords
CEA, Osteoporosis, Fracture, Prevention, Exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
exercise for strength, balance, health education
Primary Outcome Measure Information:
Title
Bone mineral density, osteoporotic fracture
Secondary Outcome Measure Information:
Title
CEA, Osteoporosis, Fracture, Prevention, Exercise

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: post menopausal women or male over 65 y/o Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Y Tsauo, PhD
Organizational Affiliation
Grad School of PT, College of Medicine, NTU
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

What is the Best Policy to Prevent Osteoporotic Fracture?

We'll reach out to this number within 24 hrs