Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114114
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
2005-06-13
Brief Title:
Dose-Response of Gonadal Steroids and Bone Turnover in Older Men
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Dose-Response of Gonadal Steroids and Bone Turnover in Older Men
Status:
COMPLETED
Status Verified Date:
2019-09
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 determine the levels of testosterone andor estradiol at which changes in bone turnover body composition strength sexual function etc begin to occur in older men This information may help determine when to intervene with hormone replacement therapy in aging men
Detailed Description:
In this protocol men age 60-75 will be randomized to one of 6 groups Groups 1-5 will receive goserelin acetate Zoladex plus 0 placebo gel 125 25 5 or 10 gday of testosterone gel Androgel Group 6 will receive placebos for both goserelin acetate and testosterone gel Note that the 10 gday dose was reduced to 75 gday part-way through the trial due to reports of possible increased risk of cardiovascular events with testosterone administration
Subjects will be blinded with respect to group assignment Dietary calcium intake will be assessed by a research dietitian and adjustments made through diet or supplements so that calcium intake is between 1000 and 1200 mgday
Subjects will be seen on the Clinical Research Center at 4 week intervals for 16 weeks 0 4 8 12 and 16 weeks At each visit compliance with Androgel will be assessed by reviewing a medication diary A standardized series of questions will be posed to each subject to assess potential side effects of the study drugs Subjects receiving Androgel will be given a new 4 week supply of medication except at week 16 A fasting blood and second voided urine sample will be collected After the blood and urine samples have been obtained subjects will be given their goserelin injection The blood and urine tests listed below as well as anthropometric measures and questionnaires will be performed at each visit Dual-energy x-ray absorptiometry DXA quantitate computed tomography QCT scans and strength assessments will be performed at 0 and 16 weeks only Subjects who discontinue participation at or after week 8 will be asked if they are willing to have an early discontinuation visit in which all procedures normally done at week 16 will be performed
The following measures will be assessed
Routine chemistries and prostate specific antigen PSA for safety assessment
Bone turnover using blood and urine tests
Hormones
Lipids
Body composition
Strength
Sexual desire and erectile function
Bone mineral density and bone microarchitecture
Subjects will be blinded with respect to group assignment Dietary calcium intake will be assessed by a research dietitian and adjustments made through diet or supplements so that calcium intake is between 1000 and 1200 mgday
Subjects will be seen on the Clinical Research Center at 4 week intervals for 16 weeks 0 4 8 12 and 16 weeks At each visit compliance with Androgel will be assessed by reviewing a medication diary A standardized series of questions will be posed to each subject to assess potential side effects of the study drugs Subjects receiving Androgel will be given a new 4 week supply of medication except at week 16 A fasting blood and second voided urine sample will be collected After the blood and urine samples have been obtained subjects will be given their goserelin injection The blood and urine tests listed below as well as anthropometric measures and questionnaires will be performed at each visit Dual-energy x-ray absorptiometry DXA quantitate computed tomography QCT scans and strength assessments will be performed at 0 and 16 weeks only Subjects who discontinue participation at or after week 8 will be asked if they are willing to have an early discontinuation visit in which all procedures normally done at week 16 will be performed
The following measures will be assessed
Routine chemistries and prostate specific antigen PSA for safety assessment
Bone turnover using blood and urine tests
Hormones
Lipids
Body composition
Strength
Sexual desire and erectile function
Bone mineral density and bone microarchitecture
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 |
|---|---|---|---|
| R01AG030545 | NIH | None | httpsreporternihgovquickSearchR01AG030545 |