Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080483
Status:
COMPLETED
Last Update Posted:
2014-06-13
First Post:
2004-04-05
Brief Title:
Testosterone and Growth Hormone for Bone Loss in Men
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Will Testosterone and Growth Hormone Improve Bone Structure
Status:
COMPLETED
Status Verified Date:
2013-12
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:
Deficiency of testosterone growth hormone or both hormones can result in osteoporosis If either hormone is replaced the condition of the bones improves The purpose of this study is to determine if dual hormone treatment for men deficient in testosterone and growth hormone improves bone structure more than testosterone treatment alone
Detailed Description:
Replacement of testosterone or growth hormone in patients who are deficient improves osteoporosis associated with these deficiencies In some tissues such as muscle the effects of testosterone and growth hormone are additive but it is not known if the effects are additive in bone as well This study will compare the effects of testosterone alone with testosterone plus growth hormone in improving bone structure in men with total pituitary hormone deficiency
Participants in this study will be men who have pituitary or hypothalamic disease and have deficiencies of all pituitary hormones but who have not been treated with either testosterone or growth hormone The men will be randomly assigned to receive either testosterone alone or testosterone plus growth hormone for two years Testosterone in a gel form will be applied daily to the skin Growth hormone will be self-administered by daily subcutaneous injection Blood concentrations of both hormones will be monitored with blood tests every 3 months during the 2-year study Doses of the hormones will be adjusted to keep blood concentrations of the hormones within the normal range Changes in bone structure will be assessed noninvasively before treatment and after one year and two years of treatment by magnetic resonance microimaging µMRI and dual energy X-ray absorptiometry DEXA
Participants in this study will be men who have pituitary or hypothalamic disease and have deficiencies of all pituitary hormones but who have not been treated with either testosterone or growth hormone The men will be randomly assigned to receive either testosterone alone or testosterone plus growth hormone for two years Testosterone in a gel form will be applied daily to the skin Growth hormone will be self-administered by daily subcutaneous injection Blood concentrations of both hormones will be monitored with blood tests every 3 months during the 2-year study Doses of the hormones will be adjusted to keep blood concentrations of the hormones within the normal range Changes in bone structure will be assessed noninvasively before treatment and after one year and two years of treatment by magnetic resonance microimaging µMRI and dual energy X-ray absorptiometry DEXA
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-118 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR050618 |
| R01AR050618 | NIH | None | None |