N/A
Completed N=177
Dose-Response of Gonadal Steroids and Bone Turnover in Older Men
Healthy Volunteers
Source: ClinicalTrials.gov NCT00114114 ↗
Enrolled (actual)
177
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX) — 103; 41; 29; 15 percentage change
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. This information may help determine when to intervene with hormone replacement therapy in aging men.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX) |
103; 41; 29; 15; 4; 11 | — |
| SECONDARY Percentage Change in Body Composition: Fat Mass |
9.8; 5.7; 1.9; 0.4; -1.6; 2.3 | — |
| SECONDARY Percentage Change in Thigh Muscle Area |
-1.5; -1.6; -0.4; -0.5; 0.5; -0.9 | — |
| SECONDARY Change in Erectile Function Symptoms |
-1.4; -0.5; -0.2; -0.1; 0.2; -0.3 | — |
| SECONDARY Change in Libido / Sexual Desire |
-1.6; -0.6; -0.6; -0.2; 0; -0.3 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy men age 60 to 75
Exclusion Criteria
- 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 65 pg/mL
- Serum thyroid stimulating hormone (TSH) 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 50
- Fracture within the last 6 months.
- Serum testosterone level 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
Data sourced from ClinicalTrials.gov (NCT00114114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.