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Trial · Interventional

CompletedNot applicableResults postedRegistry data

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

NCTNCT00114114 (opens ClinicalTrials.gov in a new tab)Other id2003-P-001868Other idR01AG030545
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
177 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Single masking
Countries
1 country

United States

Start
Sept 2004
Primary completion
1 Nov 2017
Completion
1 Nov 2017
First posted
14 Jun 2005 (estimated)
Last update posted
8 Oct 2019
Conditions
Healthy Volunteers

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200520102015
  1. N/A

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

    NCT00114114

    Sept 2004 to 1 Nov 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TestosteroneDrug
  • Goserelin acetateDrug

Arms6

  • Experimental

    Group 1: 0 g/day

    Zoladex plus Placebo Testosterone (T) gel

  • Experimental

    Group 2: 1.25 g/day

    Zoladex plus 1.25 g/day T gel

  • Experimental

    Group 3: 2.5 g/day

    Zoladex plus 2.5 g/day T gel

  • Experimental

    Group 4: 5 g/day

    Zoladex plus 5 g/day T gel

  • 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

  • Experimental

    Group 6: Placebo/Placebo (PBO/PBO)

    Placebo Zoladex plus Placebo T gel (controls)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX)

    Time frame · Baseline and 16 weeks

Secondary outcomes(4)

  1. Percentage Change in Body Composition: Fat Mass

    Time frame · Baseline and 16 weeks

  2. Percentage Change in Thigh Muscle Area

    Time frame · Baseline and 16 weeks

    Registry description

    Assessed by quantitative computed tomography (QCT)

  3. Change in Erectile Function Symptoms

    Time frame · Baseline and 16 weeks

    Registry description

    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.

  4. Change in Libido / Sexual Desire

    Time frame · 16 weeks

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and 16 weeks

Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX)

GroupValue (percentage change)Spread
Group 1: 0 g/Day10312
Group 2: 1.25 g/Day416
Group 3: 2.5 g/Day296
Group 4: 5 g/Day157
Group 5: 10* g/Day45
Group 6: Placebo/Placebo (PBO/PBO)116
Secondary and other outcome results(4)
Secondary outcomeMean· Baseline and 16 weeks

Percentage Change in Body Composition: Fat Mass

GroupValue (Percentage change)Spread
Group 1: 0 g/Day9.82.4
Group 2: 1.25 g/Day5.71.1
Group 3: 2.5 g/Day1.91.5
Group 4: 5 g/Day0.41.3
Group 5: 10* g/Day-1.61.6
Group 6: PBO/PBO2.31.9
Secondary outcomeMean· Baseline and 16 weeks

Percentage Change in Thigh Muscle Area

GroupValue (percentage change)Spread
Group 1: 0 g/Day-1.51.1
Group 2: 1.25 g/Day-1.60.9
Group 3: 2.5 g/Day-0.40.5
Group 4: 5 g/Day-0.50.7
Group 5: 10* g/Day0.50.7
Group 6: PBO/PBO-0.90.6
Secondary outcomeMean· Baseline and 16 weeks

Change in Erectile Function Symptoms

GroupValue (units on a scale)Spread
Group 1: 0 g/Day-1.40.2
Group 2: 1.25 g/Day-0.50.2
Group 3: 2.5 g/Day-0.20.2
Group 4: 5 g/Day-0.10.2
Group 5: 10* g/Day0.20.2
Group 6: PBO/PBO-0.30.2
Secondary outcomeMean· 16 weeks

Change in Libido / Sexual Desire

GroupValue (units on a scale)Spread
Group 1: 0 g/Day-1.60.2
Group 2: 1.25 g/Day-0.60.2
Group 3: 2.5 g/Day-0.60.2
Group 4: 5 g/Day-0.20.2
Group 5: 10* g/Day00.1
Group 6: PBO/PBO-0.30.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Group 1: 0 g/DayZoladex plus Placebo T gel0 / 260 / 263 / 26
Group 2: 1.25 g/DayZoladex plus 1.25 g/day T gel0 / 250 / 250 / 25
Group 3: 2.5 g/DayZoladex plus 2.5 g/day T gel0 / 310 / 310 / 31
Group 4: 5 g/DayZoladex plus 5 g/day T gel0 / 350 / 351 / 35
Group 5: 10* g/DayZoladex plus 10 g/day T gel; \*Note that the 10 g/day dose was reduced to 7.5 g/day part-way through the trial0 / 290 / 292 / 29
Group 6: PBO/PBOPlacebo Zoladex plus Placebo T gel0 / 310 / 310 / 31

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

0 studies on this page

Indexing hint: Randomized controlled trial · 2016

Gonadal steroid-dependent effects on bone turnover and bone mineral density in men.

Finkelstein et al. 2016The Journal of clinical investigationcited by 127

PMID 26901812PMC4767351DOI 10.1172/jci84137PUB-26901812

Rights unknown
Source link

More studies

3 studies on this page

Indexing hint: Randomized controlled trial · 2020

Dose-Response Relationships Between Gonadal Steroids and Bone, Body Composition, and Sexual Function in Aging Men.

Finkelstein et al. 2020The Journal of clinical endocrinology and metabolismcited by 12

PMID 32480409PMC7337183DOI 10.1210/clinem/dgaa318PUB-32480409

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2019

Effect of Testosterone on Natriuretic Peptide Levels.

Bachmann et al. 2019Journal of the American College of Cardiologycited by 38

PMID 30898204PMC6588352DOI 10.1016/j.jacc.2018.12.062PUB-30898204

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2013

Gonadal steroids and body composition, strength, and sexual function in men.

Finkelstein et al. 2013The New England journal of medicinecited by 505

PMID 24024838PMC4142768DOI 10.1056/nejmoa1206168PUB-24024838

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
Male
Age
from 60 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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