Status:
COMPLETED
Dose-Response of Gonadal Steroids and Bone Turnover in Older Men
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute on Aging (NIA)
Solvay Pharmaceuticals
Conditions:
Healthy Volunteers
Eligibility:
MALE
60-75 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the levels of testosterone and/or estradiol at which changes in bone turnover, body composition, strength, sexual function etc. begin to occur in older men. T...
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), 1.25, 2.5, 5, or 10\* g/day of testosterone gel (Androg...
Eligibility Criteria
Inclusion
- Healthy men age 60 to 75
Exclusion
- History of significant cardiac, renal, pulmonary, hepatic, benign prostatic hyperplasia, or malignant disease, current alcohol or illicit drug abuse, or major psychiatric disorders.
- Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease.
- Current use of medications known to affect bone metabolism including estrogens, androgens, anti-estrogens, bisphosphonates, calcitonin, fluoride, oral or inhaled glucocorticoids, suppressive doses of thyroxine, lithium, pharmacological doses of vitamin D (greater than 2000 IU/day), or anti-convulsants.
- Cognitive or intellectual impairment that precludes complete understanding of the study protocol.
- History of deep vein thrombosis, pulmonary embolism, or clotting disorders.
- Serum 25-hydroxyvitamin D \< 15 ng/mL
- Serum parathyroid hormone (PTH) \< 10 or \> 65 pg/mL
- Serum thyroid stimulating hormone (TSH) \< 0.5 or \> 5.0 U/L
- Serum calcium \> 10.6 mg/dL
- Serum creatinine \> 2 mg/dL
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2x the upper limit of normal
- Serum bilirubin \> 2 mg/dL
- Serum alkaline phosphatase \> 150 U/L
- Plasma hemoglobin \< 11 gm/dL
- Hematocrit \> 50
- Fracture within the last 6 months.
- Serum testosterone level \< 270 or \> 1070 ng/dL
- Serum prostate specific antigen (PSA) level \> 4 ug/L.
- International Prostate Symptom Score (IPSS) \> 19
- Systolic blood pressure \> 160 or diastolic blood pressure \> 95
- Framingham risk score greater than or equal to 20
- Difficulty walking 2 blocks
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT00114114
Start Date
September 1 2004
End Date
November 1 2017
Last Update
October 8 2019
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114