Trial Outcomes & Findings for Dose-Response of Gonadal Steroids and Bone Turnover in Older Men (NCT NCT00114114)

NCT ID: NCT00114114

Last Updated: 2019-10-08

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

177 participants

Primary outcome timeframe

Baseline and 16 weeks

Results posted on

2019-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1: 0 Grams/Day Zoladex plus Placebo T gel	Group 2: 1.25 g/Day Zoladex plus 1.25 g/day T gel	Group 3: 2.5 g/Day Zoladex plus 2.5 g/day T gel	Group 4: 5 g/Day Zoladex plus 5 g/day T gel	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	Group 6: PBO/PBO Placebo Zoladex plus Placebo T gel
Overall Study STARTED	26	25	31	35	29	31
Overall Study COMPLETED	21	24	30	31	27	30
Overall Study NOT COMPLETED	5	1	1	4	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: 0 g/Day n=26 Participants Zoladex plus Placebo T gel	Group 2: 1.25 g/Day n=25 Participants Zoladex plus 1.25 g/day T gel	Group 3: 2.5 g/Day n=31 Participants Zoladex plus 2.5 g/day T gel	Group 4: 5 g/Day n=35 Participants Zoladex plus 5 g/day T gel	Group 5: 10* g/Day n=29 Participants 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	Group 6: PBO/PBO n=31 Participants Placebo Zoladex plus Placebo T gel	Total n=177 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 5 • n=113 Participants	64 years STANDARD_DEVIATION 3 • n=163 Participants	64 years STANDARD_DEVIATION 4 • n=160 Participants	65 years STANDARD_DEVIATION 4 • n=483 Participants	65 years STANDARD_DEVIATION 3 • n=36 Participants	65 years STANDARD_DEVIATION 4 • n=10 Participants	65 years STANDARD_DEVIATION 3.9 • n=115 Participants
Sex: Female, Male Female	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Sex: Female, Male Male	26 Participants n=113 Participants	25 Participants n=163 Participants	31 Participants n=160 Participants	35 Participants n=483 Participants	29 Participants n=36 Participants	31 Participants n=10 Participants	177 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=113 Participants	1 Participants n=163 Participants	2 Participants n=160 Participants	35 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	39 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=113 Participants	23 Participants n=163 Participants	29 Participants n=160 Participants	0 Participants n=483 Participants	28 Participants n=36 Participants	30 Participants n=10 Participants	135 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	1 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	1 Participants n=10 Participants	3 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=113 Participants	0 Participants n=163 Participants	1 Participants n=160 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=113 Participants	3 Participants n=163 Participants	0 Participants n=160 Participants	4 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	8 Participants n=115 Participants
Race (NIH/OMB) White	26 Participants n=113 Participants	22 Participants n=163 Participants	29 Participants n=160 Participants	31 Participants n=483 Participants	28 Participants n=36 Participants	29 Participants n=10 Participants	165 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants	0 Participants n=163 Participants	1 Participants n=160 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment United States	26 participants n=113 Participants	25 participants n=163 Participants	31 participants n=160 Participants	35 participants n=483 Participants	29 participants n=36 Participants	31 participants n=10 Participants	177 participants n=115 Participants
Height	175.2 cm STANDARD_DEVIATION 5.7 • n=113 Participants	175.1 cm STANDARD_DEVIATION 8.7 • n=163 Participants	176.5 cm STANDARD_DEVIATION 7.9 • n=160 Participants	177.5 cm STANDARD_DEVIATION 7.6 • n=483 Participants	175.4 cm STANDARD_DEVIATION 5.0 • n=36 Participants	176.7 cm STANDARD_DEVIATION 6.5 • n=10 Participants	176.2 cm STANDARD_DEVIATION 7.0 • n=115 Participants
Weight	86.2 kg STANDARD_DEVIATION 14.1 • n=113 Participants	83.9 kg STANDARD_DEVIATION 15.0 • n=163 Participants	82.0 kg STANDARD_DEVIATION 14.2 • n=160 Participants	85.7 kg STANDARD_DEVIATION 15.1 • n=483 Participants	86.8 kg STANDARD_DEVIATION 12.2 • n=36 Participants	83.9 kg STANDARD_DEVIATION 13.0 • n=10 Participants	84.8 kg STANDARD_DEVIATION 13.9 • n=115 Participants
Body-mass Index	28.0 kg/m^2 STANDARD_DEVIATION 3.9 • n=113 Participants	27.3 kg/m^2 STANDARD_DEVIATION 4.3 • n=163 Participants	26.3 kg/m^2 STANDARD_DEVIATION 4.3 • n=160 Participants	27.1 kg/m^2 STANDARD_DEVIATION 4.2 • n=483 Participants	28.2 kg/m^2 STANDARD_DEVIATION 3.5 • n=36 Participants	26.9 kg/m^2 STANDARD_DEVIATION 4.2 • n=10 Participants	27.3 kg/m^2 STANDARD_DEVIATION 4.1 • n=115 Participants
Testosterone	496 ng/dL STANDARD_DEVIATION 176 • n=113 Participants	485 ng/dL STANDARD_DEVIATION 117 • n=163 Participants	491 ng/dL STANDARD_DEVIATION 142 • n=160 Participants	483 ng/dL STANDARD_DEVIATION 165 • n=483 Participants	484 ng/dL STANDARD_DEVIATION 148 • n=36 Participants	505 ng/dL STANDARD_DEVIATION 155 • n=10 Participants	490 ng/dL STANDARD_DEVIATION 150 • n=115 Participants
Estradiol	27 pg/mL STANDARD_DEVIATION 7 • n=113 Participants	26 pg/mL STANDARD_DEVIATION 11 • n=163 Participants	25 pg/mL STANDARD_DEVIATION 8 • n=160 Participants	30 pg/mL STANDARD_DEVIATION 11 • n=483 Participants	26 pg/mL STANDARD_DEVIATION 6 • n=36 Participants	28 pg/mL STANDARD_DEVIATION 7 • n=10 Participants	27 pg/mL STANDARD_DEVIATION 9 • n=115 Participants
Total-body Lean Mass	56177 g STANDARD_DEVIATION 6417 • n=113 Participants	55553 g STANDARD_DEVIATION 8218 • n=163 Participants	55428 g STANDARD_DEVIATION 8054 • n=160 Participants	55653 g STANDARD_DEVIATION 9206 • n=483 Participants	56081 g STANDARD_DEVIATION 6116 • n=36 Participants	55867 g STANDARD_DEVIATION 6637 • n=10 Participants	55784 g STANDARD_DEVIATION 7444 • n=115 Participants
Total body fat mass	22773 g STANDARD_DEVIATION 8693 • n=113 Participants	20827 g STANDARD_DEVIATION 7208 • n=163 Participants	19396 g STANDARD_DEVIATION 7567 • n=160 Participants	23062 g STANDARD_DEVIATION 11123 • n=483 Participants	22803 g STANDARD_DEVIATION 7459 • n=36 Participants	19931 g STANDARD_DEVIATION 7574 • n=10 Participants	21471 g STANDARD_DEVIATION 8564 • n=115 Participants
Thigh-muscle area	15272 mm^2 STANDARD_DEVIATION 2026 • n=113 Participants	16006 mm^2 STANDARD_DEVIATION 2515 • n=163 Participants	15281 mm^2 STANDARD_DEVIATION 2645 • n=160 Participants	15367 mm^2 STANDARD_DEVIATION 2820 • n=483 Participants	15771 mm^2 STANDARD_DEVIATION 2145 • n=36 Participants	15572 mm^2 STANDARD_DEVIATION 2157 • n=10 Participants	15531 mm^2 STANDARD_DEVIATION 2424 • n=115 Participants

PRIMARY outcome

Timeframe: Baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Group 1: 0 g/Day n=21 Participants Zoladex plus Placebo Testosterone (T) gel	Group 2: 1.25 g/Day n=24 Participants Zoladex plus 1.25 g/day T gel	Group 3: 2.5 g/Day n=30 Participants Zoladex plus 2.5 g/day T gel	Group 4: 5 g/Day n=31 Participants Zoladex plus 5 g/day T gel	Group 5: 10* g/Day n=27 Participants 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	Group 6: Placebo/Placebo (PBO/PBO) n=30 Participants Placebo Zoladex plus Placebo T gel
Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX)	103 percentage change Standard Error 12	41 percentage change Standard Error 6	29 percentage change Standard Error 6	15 percentage change Standard Error 7	4 percentage change Standard Error 5	11 percentage change Standard Error 6

SECONDARY outcome

Timeframe: Baseline and 16 weeks

Outcome measures

Outcome measures
Measure	Group 1: 0 g/Day n=21 Participants Zoladex plus Placebo Testosterone (T) gel	Group 2: 1.25 g/Day n=24 Participants Zoladex plus 1.25 g/day T gel	Group 3: 2.5 g/Day n=30 Participants Zoladex plus 2.5 g/day T gel	Group 4: 5 g/Day n=31 Participants Zoladex plus 5 g/day T gel	Group 5: 10* g/Day n=27 Participants 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	Group 6: Placebo/Placebo (PBO/PBO) n=30 Participants Placebo Zoladex plus Placebo T gel
Percentage Change in Body Composition: Fat Mass	9.8 Percentage change Standard Error 2.4	5.7 Percentage change Standard Error 1.1	1.9 Percentage change Standard Error 1.5	0.4 Percentage change Standard Error 1.3	-1.6 Percentage change Standard Error 1.6	2.3 Percentage change Standard Error 1.9

SECONDARY outcome

Timeframe: Baseline and 16 weeks

Assessed by quantitative computed tomography (QCT)

Outcome measures

Outcome measures
Measure	Group 1: 0 g/Day n=21 Participants Zoladex plus Placebo Testosterone (T) gel	Group 2: 1.25 g/Day n=24 Participants Zoladex plus 1.25 g/day T gel	Group 3: 2.5 g/Day n=30 Participants Zoladex plus 2.5 g/day T gel	Group 4: 5 g/Day n=31 Participants Zoladex plus 5 g/day T gel	Group 5: 10* g/Day n=27 Participants 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	Group 6: Placebo/Placebo (PBO/PBO) n=30 Participants Placebo Zoladex plus Placebo T gel
Percentage Change in Thigh Muscle Area	-1.5 percentage change Standard Error 1.1	-1.6 percentage change Standard Error 0.9	-0.4 percentage change Standard Error 0.5	-0.5 percentage change Standard Error 0.7	0.5 percentage change Standard Error 0.7	-0.9 percentage change Standard Error 0.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1: 0 g/Day n=21 Participants Zoladex plus Placebo Testosterone (T) gel	Group 2: 1.25 g/Day n=24 Participants Zoladex plus 1.25 g/day T gel	Group 3: 2.5 g/Day n=30 Participants Zoladex plus 2.5 g/day T gel	Group 4: 5 g/Day n=31 Participants Zoladex plus 5 g/day T gel	Group 5: 10* g/Day n=27 Participants 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	Group 6: Placebo/Placebo (PBO/PBO) n=30 Participants Placebo Zoladex plus Placebo T gel
Change in Erectile Function Symptoms	-1.4 units on a scale Standard Error 0.2	-0.5 units on a scale Standard Error 0.2	-0.2 units on a scale Standard Error 0.2	-0.1 units on a scale Standard Error 0.2	0.2 units on a scale Standard Error 0.2	-0.3 units on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: 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