HypogonadismPhase 2NCT01460654
Testosterone and Alendronate in Hypogonadal Men
A Phase 2 study testing Testosterone and Alendronate in people with Hypogonadism and Osteopenia, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism, Osteopenia, Osteoporosis
- What is being tested?
- Testosterone and Alendronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant liver or kidney disease
- Elevated prolactin level
- Abnormal TSH
- Abnormal 25-Vitamin D
- PSA > 2.5
- History of malignancy
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Hypogonadism, Osteopenia, Osteoporosis
- Being tested
- Testosterone, Alendronate, Placebo Alendronate, Placebo Testosterone
- Medical subject headings
- Hypogonadism, Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Testosterone Gel (Fortesta) 40mg daily.
AlendronateDrug
Alendronate (Fosamax) 70mg every week.
Placebo AlendronateDrug
A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.
Placebo TestosteroneDrug
Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone and Placebo Alendronate | Placebo comparator | Not described Receives: Drug: Testosterone; Drug: Placebo Alendronate |
| Alendronate and Placebo Testosterone | Placebo comparator | Not described Receives: Drug: Alendronate; Drug: Placebo Testosterone |
| Testosterone and Alendronate | Experimental | Not described Receives: Drug: Testosterone; Drug: Alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Spine Bone Density From Baseline to 12 Months
Percent Change in Spine Bone Density from Baseline (month 0) to Month 12
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company, Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Benjamin Leder, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460654
- Sponsor's protocol ID
- MGH-988
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2011
- Last updated
- 12 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone and Alendronate in Hypogonadal Men
- ClinicalTrials.gov ID
- NCT01460654
- Acronym / sponsor ID
- MGH-988
- Conditions
- Hypogonadism, Osteopenia, Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company, Merck Sharp & Dohme LLC
- Study start
- Oct 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Oct 2011 (estimated)
- Results
- Posted 12 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Testosterone and Placebo Alendronate | Placebo comparator | Drug: Testosterone, Drug: Placebo Alendronate |
| Alendronate and Placebo Testosterone | Placebo comparator | Drug: Alendronate, Drug: Placebo Testosterone |
| Testosterone and Alendronate | Experimental | Drug: Testosterone, Drug: Alendronate |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- Significant liver or kidney disease
- Elevated prolactin level
- Abnormal TSH
- Abnormal 25-Vitamin D
- PSA > 2.5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TestosteroneTestosterone Gel (Fortesta) 40mg daily. | Drug | Testosterone and Alendronate, Testosterone and Placebo Alendronate |
| AlendronateAlendronate (Fosamax) 70mg every week. | Drug | Alendronate and Placebo Testosterone, Testosterone and Alendronate |
| Placebo AlendronateA placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group. | Drug | Testosterone and Placebo Alendronate |
| Placebo TestosteronePlacebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group. | Drug | Alendronate and Placebo Testosterone |
Primary outcome
Percent Change in Spine Bone Density From Baseline to 12 Months
Time frame: Baseline and 12 months
Percent Change in Spine Bone Density from Baseline (month 0) to Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Testosterone and Alendronate in people with Hypogonadism and Osteopenia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Spine Bone Density From Baseline to 12 Months (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.