Hypogonadism, Osteopenia, Osteoporosis
Conditions
Brief summary
This study will investigate the hypothesis that the combination of testosterone replacement and alendronate will improve bone density and parameters of bone quality more than either medication alone in older men with low testosterone levels and low bone density.
Interventions
DRUGTestosterone
Testosterone Gel (Fortesta) 40mg daily.
DRUGAlendronate
Alendronate (Fosamax) 70mg every week.
A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.
Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.
Sponsors
Endo Pharmaceuticals
Merck Sharp & Dohme LLC
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
60 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Male sex * Age 60 or above * Testosterone \<300 ng/dL * DXA T score \< -1 OR FRAX Score of 3% or greater for hip fracture or 20% or greater for major osteoporotic fracture
Exclusion criteria
* Significant liver or kidney disease * Elevated prolactin level * Abnormal TSH * Abnormal 25-Vitamin D * PSA \> 2.5 * History of malignancy * Calcium \> 10.6 * Alkaline Phosphatase \> 150 * Fracture within the last 6 months * History of acute urinary retention * Hematocrit \< 32% or \> 50% * Fracture within the past 6 months * American Urological Association BPH symptom index \> 21 * Sleep apnea * Abnormalities of the esophagus which delay esophageal emptying * Significant cardiopulmonary disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Spine Bone Density From Baseline to 12 Months | Baseline and 12 months | Percent Change in Spine Bone Density from Baseline (month 0) to Month 12 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 10 |
| Testosterone and Alendronate Testosterone: Testosterone Gel (Fortesta) 40mg daily.
Alendronate: Alendronate (Fosamax) 70mg every week. | 15 |
| Total | 44 |
Baseline characteristics
| Characteristic | Alendronate and Placebo Testosterone | Testosterone and Alendronate | Testosterone and Placebo Alendronate | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 12 Participants | 17 Participants | 37 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Age, Continuous | 70.1 years STANDARD_DEVIATION 6.5 | 69.8 years STANDARD_DEVIATION 5.1 | 68.0 years STANDARD_DEVIATION 4.9 | 69.1 years STANDARD_DEVIATION 5.3 |
| Region of Enrollment United States | 10 participants | 15 participants | 19 participants | 44 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 10 Participants | 15 Participants | 19 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 19 | 8 / 10 | 7 / 15 |
| serious Total, serious adverse events | 2 / 19 | 1 / 10 | 0 / 15 |
Outcome results
Primary
Percent Change in Spine Bone Density From Baseline to 12 Months
Percent Change in Spine Bone Density from Baseline (month 0) to Month 12
Time frame: Baseline and 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone and Placebo Alendronate | Percent Change in Spine Bone Density From Baseline to 12 Months | 2.52 percent change of bone mineral density | Standard Deviation 0.02 |
| Alendronate and Placebo Testosterone | Percent Change in Spine Bone Density From Baseline to 12 Months | 0.61 percent change of bone mineral density | Standard Deviation 0.03 |
| Testosterone and Alendronate | Percent Change in Spine Bone Density From Baseline to 12 Months | 3.16 percent change of bone mineral density | Standard Deviation 0.04 |