Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182871
Status:
COMPLETED
Last Update Posted:
2009-10-30
First Post:
2005-09-12
Brief Title:
Testosterone Effects on Bone and Frailty
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Testosterone Effects on Bone and Frailty in Men With Osteoporosis
Status:
COMPLETED
Status Verified Date:
2009-10
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:
The purpose of this study is to assess the effects of testosterone replacement on bone density muscle strength physical performance quality of life and prostate symptoms in men selected for low bone mineral density or fracture and some aspect of frailty
Detailed Description:
The hypothesis being tested is that testosterone supplementation can increase bone mineral density and specific parameters of frailty in older men with osteoporosis and characteristics of frailty One hundred and eighty men age 60 years and older who have sustained a hip fracture or other fragility fracture following mild to moderate trauma such as a fall from standing height in the previous 5 years or who have low femoral neck bone mineral density plus a component of frailty weight loss perception of exhaustion physical strength physical activity level and walking time will be randomly assigned to receive either testosterone or placebo delivered by topical gel applied daily in a two year double-blind study
Bone mineral density BMD by dual x-ray absorptiometry DXA will be performed at baseline and yearly to assess changes in BMD Blood and urine samples will be collected at baseline and yearly these tests will be correlated to changes in BMD
To determine the effects of testosterone on frailty strength of the upper and lower extremities will be measured every 6 months using the hand-held dynamometer and sitting leg press respectively Changes in lean body mass and percent body fat will be measured by total body DXA at baseline 6 months and then annually In addition physical performance emotional and sexual function and disability will be assessed also
The safety of testosterone supplementation on prostate and cardiovascular parameters will also be monitored participants will be screened for prostate cancer at baseline 6 months then yearly for 2 years Fasting lipoprotein levels will be measured yearly while on testosterone replacement and cardiovascular specific adverse effects such as angina myocardial infarction stroke and sudden death will be tracked
Bone mineral density BMD by dual x-ray absorptiometry DXA will be performed at baseline and yearly to assess changes in BMD Blood and urine samples will be collected at baseline and yearly these tests will be correlated to changes in BMD
To determine the effects of testosterone on frailty strength of the upper and lower extremities will be measured every 6 months using the hand-held dynamometer and sitting leg press respectively Changes in lean body mass and percent body fat will be measured by total body DXA at baseline 6 months and then annually In addition physical performance emotional and sexual function and disability will be assessed also
The safety of testosterone supplementation on prostate and cardiovascular parameters will also be monitored participants will be screened for prostate cancer at baseline 6 months then yearly for 2 years Fasting lipoprotein levels will be measured yearly while on testosterone replacement and cardiovascular specific adverse effects such as angina myocardial infarction stroke and sudden death will be tracked
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 |
|---|---|---|---|
| R01AG018887 | NIH | None | httpsreporternihgovquickSearchR01AG018887 |