Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000399
Status:
COMPLETED
Last Update Posted:
2013-05-20
First Post:
1999-11-03
Brief Title:
Bone Estrogen Strength Training
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Bone Estrogen Strength Training BEST
Status:
COMPLETED
Status Verified Date:
2013-05
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:
We started the Bone Estrogen Strength Training BEST study in the fall of 1995 at the University of Arizona Tucson Arizona The BEST study is the largest of its kind It looks at the effects of hormone replacement therapy and strength training exercise on bone mineral density Bone mineral density affects bone strength and the risk of osteoporosis Six groups of about 300 women each participated in this osteoporosis prevention study In 1998 the BEST study received additional funding to examine for another 2 years the long-term effects of strength training on bone mineral density By 2001 we will have finished analyzing the results for all study groups on the 1-year effects of exercise on bone as well as additional analyses on the effects of 2 3 and 4 years of strength training and weight-bearing exercise on bone
Detailed Description:
Osteoporotic fractures associated with low bone mineral density BMD are a significant public health problem for women resulting in over 1 million fractures per year The increasing incidence of fractures will make an already major health problem an even greater one in the future Estimates of medical costs for the treatment of osteoporotic fractures are expected to increase from 148 billion in 1995 to 60 billion by 2020 Although the Womens Health Initiative is investigating dietary and hormonal factors in relation to bone density it is not investigating the effects of exercise on reducing bone mineral loss in postmenopausal women
This study includes completion of a large partially randomized clinical trial evaluating the effect of a 1-year exercise intervention on total body and regional BMD in two populations hormone replacement therapy HRT versus no HRT of postmenopausal women with a previous history of physical inactivity A major hypothesis is that compared to the no-exercise group the exercise intervention will be an effective alternative to reduce the risk of osteoporosis and the exercise effects will be larger in the cohort of women on HRT than those not on HRT
The exercise program includes progressive resistance exercises using free weights and weight resistance machines and weight-bearing aerobic exercises We carefully supervise and monitor the exercise compliance by keeping records of the amount of exercise completed at each of three weekly exercise sessions and by measuring strength gains of selected muscle groups We will measure biochemical markers of bone formation and resorption and hormonal correlates of bone mineral density changes including sex steroids at baseline 6 months and 1 year
We have obtained duplicate blood collections made one week apart for all cohorts at each of the three measurement periods We have also collected duplicate dual energy x-ray absorptiometry DXA scans at each time period to follow changes in axial and appendicular BMD and total and regional soft tissue body composition as a result of the intervention We collected extensive dietary intake records during the first year of intervention we will monitor dietary intake in a 2-year followup using food frequency questionnaires We will also measure followup BMD soft tissue and lean and fat body composition for 2 years in all women who complete the first-year intervention program
Two-hundred sixty-six women have completed the first year of the intervention The study has a retention rate of 92 percent in the first year for the first four cohorts
Because of the paucity of information regarding long-term effects of exercise and because of the increased emphasis in the scientific community on evaluating the long-term efficacy of exercise interventions for osteoporosis prevention this comprehensive 1-year clinical trial and 2-year followup will make an important contribution to determining the future role of combining progressive resistance and weight bearing aerobic exercise in the prevention of osteoporosis in two populations HRT vs no HRT of postmenopausal women
This study includes completion of a large partially randomized clinical trial evaluating the effect of a 1-year exercise intervention on total body and regional BMD in two populations hormone replacement therapy HRT versus no HRT of postmenopausal women with a previous history of physical inactivity A major hypothesis is that compared to the no-exercise group the exercise intervention will be an effective alternative to reduce the risk of osteoporosis and the exercise effects will be larger in the cohort of women on HRT than those not on HRT
The exercise program includes progressive resistance exercises using free weights and weight resistance machines and weight-bearing aerobic exercises We carefully supervise and monitor the exercise compliance by keeping records of the amount of exercise completed at each of three weekly exercise sessions and by measuring strength gains of selected muscle groups We will measure biochemical markers of bone formation and resorption and hormonal correlates of bone mineral density changes including sex steroids at baseline 6 months and 1 year
We have obtained duplicate blood collections made one week apart for all cohorts at each of the three measurement periods We have also collected duplicate dual energy x-ray absorptiometry DXA scans at each time period to follow changes in axial and appendicular BMD and total and regional soft tissue body composition as a result of the intervention We collected extensive dietary intake records during the first year of intervention we will monitor dietary intake in a 2-year followup using food frequency questionnaires We will also measure followup BMD soft tissue and lean and fat body composition for 2 years in all women who complete the first-year intervention program
Two-hundred sixty-six women have completed the first year of the intervention The study has a retention rate of 92 percent in the first year for the first four cohorts
Because of the paucity of information regarding long-term effects of exercise and because of the increased emphasis in the scientific community on evaluating the long-term efficacy of exercise interventions for osteoporosis prevention this comprehensive 1-year clinical trial and 2-year followup will make an important contribution to determining the future role of combining progressive resistance and weight bearing aerobic exercise in the prevention of osteoporosis in two populations HRT vs no HRT of postmenopausal women
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-006 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR039559 |
| R01AR039559 | NIH | None | None |