Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00173693
Status:
WITHDRAWN
Last Update Posted:
2012-12-10
First Post:
2005-09-12
Brief Title:
What is the Best Policy to Prevent Osteoporotic Fracture
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
1To 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 2To 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
3To 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
-- --
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 FU of the items collected at baseline
3 To investigate the effects of each intervention program
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
1To 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 2To 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
3To 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
-- --
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 FU of the items collected at baseline
3 To investigate the effects of each intervention program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None