Dose-Response of Gonadal Steroids and Bone Turnover in Older Men
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| ClinicalTrials.gov Identifier: NCT00114114 |
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Recruitment Status :
Completed
First Posted : June 14, 2005
Results First Posted : September 17, 2019
Last Update Posted : October 8, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy Volunteers | Drug: Testosterone Drug: Goserelin acetate | Not Applicable |
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 (Androgel). Group 6 will receive placebos for both goserelin acetate and testosterone gel. (*Note that the 10 g/day dose was reduced to 7.5 g/day 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 mg/day.
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 177 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Diagnostic |
| Official Title: | Dose-Response of Gonadal Steroids and Bone Turnover in Older Men |
| Study Start Date : | September 2004 |
| Actual Primary Completion Date : | November 1, 2017 |
| Actual Study Completion Date : | November 1, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group 1: 0 g/day
Zoladex plus Placebo Testosterone (T) gel
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Drug: Testosterone
Androgel placebo or 1.25, 2.5, 5. or 10* gms topically each day
Other Name: Androgel Drug: Goserelin acetate 3.6 gms sc every 4 weeks
Other Name: Zoladex |
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Experimental: Group 2: 1.25 g/day
Zoladex plus 1.25 g/day T gel
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Drug: Testosterone
Androgel placebo or 1.25, 2.5, 5. or 10* gms topically each day
Other Name: Androgel Drug: Goserelin acetate 3.6 gms sc every 4 weeks
Other Name: Zoladex |
|
Experimental: Group 3: 2.5 g/day
Zoladex plus 2.5 g/day T gel
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Drug: Testosterone
Androgel placebo or 1.25, 2.5, 5. or 10* gms topically each day
Other Name: Androgel Drug: Goserelin acetate 3.6 gms sc every 4 weeks
Other Name: Zoladex |
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Experimental: Group 4: 5 g/day
Zoladex plus 5 g/day T gel
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Drug: Testosterone
Androgel placebo or 1.25, 2.5, 5. or 10* gms topically each day
Other Name: Androgel Drug: Goserelin acetate 3.6 gms sc every 4 weeks
Other Name: Zoladex |
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Experimental: Group 5: 10* g/day
Zoladex plus 10* g/day T gel. *Note that the 10 g/day dose was reduced to 7.5 g/day part-way through the trial
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Drug: Testosterone
Androgel placebo or 1.25, 2.5, 5. or 10* gms topically each day
Other Name: Androgel Drug: Goserelin acetate 3.6 gms sc every 4 weeks
Other Name: Zoladex |
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Experimental: Group 6: Placebo/Placebo (PBO/PBO)
Placebo Zoladex plus Placebo T gel (controls)
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Drug: Testosterone
Androgel placebo or 1.25, 2.5, 5. or 10* gms topically each day
Other Name: Androgel Drug: Goserelin acetate 3.6 gms sc every 4 weeks
Other Name: Zoladex |
- Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX) [ Time Frame: Baseline and 16 weeks ]
- Percentage Change in Body Composition: Fat Mass [ Time Frame: Baseline and 16 weeks ]
- Percentage Change in Thigh Muscle Area [ Time Frame: Baseline and 16 weeks ]Assessed by quantitative computed tomography (QCT)
- Change in Erectile Function Symptoms [ Time Frame: Baseline and 16 weeks ]Based on International Index of Erectile Function (IIEF) scale, question #15, which asked subjects to rate their confidence that they could achieve and maintain an erection. Scores range from 1 to 5, with higher scores being better.
- Change in Libido / Sexual Desire [ Time Frame: 16 weeks ]Change in libido from baseline (scale ranges from -2 to +2), with -2 being much less, -1 somewhat less, 0 same, +1 somewhat more, +2 much more
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 60 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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 < 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114114
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Ben Z Leder, MD | Massachusetts General Hospital |
Documents provided by Benjamin Leder, MD, Massachusetts General Hospital:
| Responsible Party: | Benjamin Leder, MD, Principal Investigator, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00114114 |
| Other Study ID Numbers: |
2003-P-001868 R01AG030545 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 14, 2005 Key Record Dates |
| Results First Posted: | September 17, 2019 |
| Last Update Posted: | October 8, 2019 |
| Last Verified: | September 2019 |
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Testosterone Bone turnover Aging |
Body composition Hypogonadism Sexual function |
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Goserelin Testosterone Androgens Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |