Dose-Response of Gonadal Steroids and Bone Turnover in Men
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Purpose
| Condition | Intervention |
|---|---|
|
Healthy Volunteers |
Drug: Testosterone Drug: Anastrazole Drug: Goserelin acetate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic |
| Official Title: | Dose-Response of Gonadal Steroids and Bone Turnover in Men |
- Bone turnover [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Body composition [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Strength [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Symptoms [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Sexual function [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 900 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | July 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1: Men age 20-50
Goserelin acetate (Zoladex) plus testosterone (or placebo) in men age 20-50. This arm is complete and no longer recruiting. Men were assigned to 1 of 6 groups: G1= Zoladex plus placebo T; G2= Zoladex plus 1.25 gm T gel/day; G3: Zoladex plus 2.5 gm T gel/day; G4: Zoladex plus 5 gm T gel/day; G5: Zoladex plus 10 gm T gel/day; G6: Placebo Zoladex plus placebo T gel. |
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: 2: Men age 20-50
Goserelin acetate (Zoladex) plus testosterone (or placebo) plus anastrazole in men age 20-50. This arm is complete and no longer recruiting. Men were assigned to 1 of 6 groups: G1= Zoladex plus placebo T; G2= Zoladex plus 1.25 gm T gel/day; G3: Zoladex plus 2.5 gm T gel/day; G4: Zoladex plus 5 gm T gel/day; G5: Zoladex plus 10 gm T gel/day; G6: Placebo Zoladex plus placebo T gel. In addition, all men received anastrozole 1 mg/day. |
Drug: Testosterone
Androgel placebo or 1.25, 2.5, 5. or 10 gms topically each day
Other Name: Androgel
Drug: Anastrazole
1 mg by mouth daily
Other Name: Arimidex
Drug: Goserelin acetate
3.6 gms sc every 4 weeks
Other Name: Zoladex
|
|
Experimental: 3: Men age 60-75
Goserelin acetate (Zoladex) plus testosterone (or placebo) in men age 60 to 75. This arm is open to recruitment. Men are assigned to 1 of 6 groups: G1= Zoladex plus placebo T; G2= Zoladex plus 1.25 gm T gel/day; G3: Zoladex plus 2.5 gm T gel/day; G4: Zoladex plus 5 gm T gel/day; G5: Zoladex plus 10 gm T gel/day; G6: Placebo Zoladex plus placebo T gel. |
Drug: Testosterone
Androgel placebo or 1.25, 2.5, 5. or 7.5 gms topically each day
Other Name: Androgel
Drug: Goserelin acetate
3.6 gms sc every 4 weeks
Other Name: Zoladex
|
Detailed Description:
There are 3 arms to this protocol, each with 5 or 6 groups.
In Arm 1, 240 men age 20-50 will receive goserelin acetate (Zoladex) plus Androgel (or placebo). (NOTE: ARM 1 IS CLOSED TO RECRUITMENT.
In Arm 2, 200 men age 20-50 will receive goserelin acetate (Zoladex) plus Androgel (or placebo) plus anastrazole (Arimidex). NOTE: ARM 2 IS CLOSED TO RECRUITMENT..
In Arm 3, 240 men age 60 to 75 will receive goserelin acetate (Zoladex) plus Androgel (or placebo). (Arm 3 is recruiting).
Subjects will be screened on the MGH General Clinical Research Center (GCRC). After obtaining informed consent for the screening procedures, subjects will undergo a complete history and physical examination. If no exclusionary findings are noted during the history and physical examination, blood will be drawn to measure hemoglobin, routine chemistries (including serum calcium, liver function tests, and creatinine), and serum levels of PTH, 25-OH vitamin D, TSH, T, and PSA.
For Arm 3, subjects who are successfully screened will be randomly assigned by a computer to one of 6 groups. All subjects will receive a GnRH agonist goserelin acetate (Zoladex; AstraZeneca, Wilmington, DE) 3.6 mg sc every 4 weeks for 16 weeks. Subjects in Group 1 will receive goserelin acetate and placebo for Androgel. Subjects in Groups 2-5 will receive varying doses of Androgel. Subjects in Group 6 will receive double placebo (e.g. placebo Zoladex and placebo Androgel). 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 GCRC 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. DXA, CT 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 PSA (for safety assessment)
- Bone turnover using blood and urine tests
- Hormones
- Lipids
- Body composition
- Strength
- Symptoms of hypogonadism
- Bone mineral density and bone microarchitecture
Eligibility| Ages Eligible for Study: | 60 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy men age 20 to 50 years or 60 to 75. NOTE: RECRUITMENT OF MEN AGE 20-50 IS COMPLETE.
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-OH vitamin D < 15 ng/mL
- Serum PTH < 10 or > 65 pg/mL
- Serum TSH < 0.5 or > 5.0 U/L
- Serum calcium > 10.6 mg/dL
- Serum creatinine > 2 mg/dL
- Serum AST or ALT > 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 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00114114
| Contact: JOEL S. FINKELSTEIN, MD | 617-726-6723 | jfinkelstein@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: JOEL S. FINKELSTEIN, MD 617-726-6723 jfinkelstein@partners.org | |
| Contact: Benjamin Z Leder, MD 617-726-6723 bzleder@partners.org | |
| Principal Investigator: JOEL S. FINKELSTEIN, MD | |
| Principal Investigator: | JOEL S. FINKELSTEIN, MD | Massachusetts General Hospital |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Joel S. Finkelstein, MD, Associate Professor ofMedicine, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00114114 History of Changes |
| Other Study ID Numbers: | 2003-P-001868 R01AG030545 |
| Study First Received: | June 13, 2005 |
| Last Updated: | September 16, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Testosterone Bone turnover Aging |
Body composition Hypogonadism Sexual function |
Additional relevant MeSH terms:
|
Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Anastrozole Goserelin Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists |
ClinicalTrials.gov processed this record on September 26, 2016