Dose-Response of Gonadal Steroids and Bone Turnover in Older Men

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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. This information may help determine when to intervene with hormone replacement therapy in aging men.

Key facts

Study ID

NCT00114114

Run by

Massachusetts General Hospital

People needed

177

Starts

2004-09-01

Expected to finish

2017-11-01

Last updated by the study team

2019-10-08

Who can join

Age: 60 and older, up to 75. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy men age 60 to 75

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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