Trial Outcomes & Findings for Testosterone and Alendronate in Hypogonadal Men (NCT NCT01460654)
NCT ID: NCT01460654
Last Updated: 2023-10-12
Results Overview
Percent Change in Spine Bone Density from Baseline (month 0) to Month 12
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2023-10-12
Participant Flow
Participant milestones
| Measure |
Testosterone and Placebo Alendronate
Testosterone: Testosterone Gel (Fortesta) 40mg daily.
Placebo Alendronate: A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.
|
Alendronate and Placebo Testosterone
Alendronate: Alendronate (Fosamax) 70mg every week.
Placebo Testosterone: Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.
|
Testosterone and Alendronate
Testosterone: Testosterone Gel (Fortesta) 40mg daily.
Alendronate: Alendronate (Fosamax) 70mg every week.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
10
|
15
|
|
Overall Study
COMPLETED
|
14
|
9
|
13
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testosterone and Alendronate in Hypogonadal Men
Baseline characteristics by cohort
| Measure |
Testosterone and Placebo Alendronate
n=19 Participants
Testosterone: Testosterone Gel (Fortesta) 40mg daily.
Placebo Alendronate: A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.
|
Alendronate and Placebo Testosterone
n=10 Participants
Alendronate: Alendronate (Fosamax) 70mg every week.
Placebo Testosterone: Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.
|
Testosterone and Alendronate
n=15 Participants
Testosterone: Testosterone Gel (Fortesta) 40mg daily.
Alendronate: Alendronate (Fosamax) 70mg every week.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
|
Age, Continuous
|
68.0 years
STANDARD_DEVIATION 4.9 • n=99 Participants
|
70.1 years
STANDARD_DEVIATION 6.5 • n=107 Participants
|
69.8 years
STANDARD_DEVIATION 5.1 • n=206 Participants
|
69.1 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
10 participants
n=107 Participants
|
15 participants
n=206 Participants
|
44 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPercent Change in Spine Bone Density from Baseline (month 0) to Month 12
Outcome measures
| Measure |
Testosterone and Placebo Alendronate
n=14 Participants
Testosterone: Testosterone Gel (Fortesta) 40mg daily.
Placebo Alendronate: A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.
|
Alendronate and Placebo Testosterone
n=9 Participants
Alendronate: Alendronate (Fosamax) 70mg every week.
Placebo Testosterone: Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.
|
Testosterone and Alendronate
n=13 Participants
Testosterone: Testosterone Gel (Fortesta) 40mg daily.
Alendronate: Alendronate (Fosamax) 70mg every week.
|
|---|---|---|---|
|
Percent Change in Spine Bone Density From Baseline to 12 Months
|
2.52 percent change of bone mineral density
Standard Deviation 0.02
|
0.61 percent change of bone mineral density
Standard Deviation 0.03
|
3.16 percent change of bone mineral density
Standard Deviation 0.04
|
Adverse Events
Testosterone and Placebo Alendronate
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Alendronate and Placebo Testosterone
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Testosterone and Alendronate
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Testosterone and Placebo Alendronate
n=19 participants at risk
Testosterone: Testosterone Gel (Fortesta) 40mg daily.
Placebo Alendronate: A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.
|
Alendronate and Placebo Testosterone
n=10 participants at risk
Alendronate: Alendronate (Fosamax) 70mg every week.
Placebo Testosterone: Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.
|
Testosterone and Alendronate
n=15 participants at risk
Testosterone: Testosterone Gel (Fortesta) 40mg daily.
Alendronate: Alendronate (Fosamax) 70mg every week.
|
|---|---|---|---|
|
Renal and urinary disorders
nephrolithiasis
|
5.3%
1/19
|
0.00%
0/10
|
0.00%
0/15
|
|
Renal and urinary disorders
bladder cancer
|
5.3%
1/19
|
0.00%
0/10
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
spinal stenosis
|
0.00%
0/19
|
10.0%
1/10
|
0.00%
0/15
|
Other adverse events
| Measure |
Testosterone and Placebo Alendronate
n=19 participants at risk
Testosterone: Testosterone Gel (Fortesta) 40mg daily.
Placebo Alendronate: A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.
|
Alendronate and Placebo Testosterone
n=10 participants at risk
Alendronate: Alendronate (Fosamax) 70mg every week.
Placebo Testosterone: Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.
|
Testosterone and Alendronate
n=15 participants at risk
Testosterone: Testosterone Gel (Fortesta) 40mg daily.
Alendronate: Alendronate (Fosamax) 70mg every week.
|
|---|---|---|---|
|
Cardiac disorders
chest discomfort
|
15.8%
3/19
|
0.00%
0/10
|
0.00%
0/15
|
|
Gastrointestinal disorders
diarrhea
|
5.3%
1/19
|
0.00%
0/10
|
0.00%
0/15
|
|
Nervous system disorders
dizziness
|
5.3%
1/19
|
0.00%
0/10
|
6.7%
1/15
|
|
Cardiac disorders
hypertension
|
5.3%
1/19
|
10.0%
1/10
|
0.00%
0/15
|
|
Eye disorders
glaucoma
|
5.3%
1/19
|
0.00%
0/10
|
0.00%
0/15
|
|
Infections and infestations
Shingles
|
5.3%
1/19
|
0.00%
0/10
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Sinus surgery
|
5.3%
1/19
|
0.00%
0/10
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.8%
3/19
|
20.0%
2/10
|
33.3%
5/15
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
5.3%
1/19
|
10.0%
1/10
|
13.3%
2/15
|
|
Endocrine disorders
hypoglycemia
|
0.00%
0/19
|
10.0%
1/10
|
6.7%
1/15
|
|
Blood and lymphatic system disorders
Elevated hematocrit
|
0.00%
0/19
|
20.0%
2/10
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Sciatic nerve pain
|
0.00%
0/19
|
10.0%
1/10
|
0.00%
0/15
|
|
Renal and urinary disorders
prostate nodule
|
0.00%
0/19
|
10.0%
1/10
|
0.00%
0/15
|
|
Renal and urinary disorders
hematuria
|
0.00%
0/19
|
0.00%
0/10
|
6.7%
1/15
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/19
|
0.00%
0/10
|
6.7%
1/15
|
|
Renal and urinary disorders
Elevated creatinine
|
0.00%
0/19
|
0.00%
0/10
|
6.7%
1/15
|
|
Renal and urinary disorders
Elevated prostrate screen antigen
|
0.00%
0/19
|
0.00%
0/10
|
6.7%
1/15
|
|
Gastrointestinal disorders
Crohns disease
|
0.00%
0/19
|
0.00%
0/10
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
plantar fascitis
|
0.00%
0/19
|
0.00%
0/10
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
muscle ache
|
0.00%
0/19
|
0.00%
0/10
|
13.3%
2/15
|
|
Musculoskeletal and connective tissue disorders
achilles tendon tear
|
0.00%
0/19
|
0.00%
0/10
|
6.7%
1/15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place