HypogonadismNCT00838838
Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis
An observational study of Hypogonadism and Paraplegia, run by Bayer at 1 site in Germany.
Trial summary
Both conditions hypogonadism and immobilisation (paraplegia) may contribute or lead to decreased bone mineral density resp osteoporosis. In this study bone mineral density is assessed in hypogonadal paraplegic patients, who are on standard prophylactic therapy for osteoporosis and and on a standard physiotherapy… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypogonadism, Paraplegia, Bone Density
- What is being tested?
- Testosterone Undeconate (Nebido-R, BAY86-5037)
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2005to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients > 18yrs in medical practices fulfilling all criteria for documentation.
Who may be able to join
- Male patients > 18yrs
- Osteoporosis prophylaxis/therapy with
- vitamin D 800 - 1200 mg per day,
- calcium 800 - 1000 mg per day,
- Fosamax 70 once a week.
- Standardised physiotherapy exercise programme.
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- No proliferative bone disease.
- No history of calcium oxalate stones.
- No use of aromatase inhibitors.
- No use of 5-alpha reductase inhibitors.
- Nebido group:
- No contraindications to use of Nebido (known prostate or breast carcinoma or suspicion thereof, no past or present history of liver tumours);
- No known hypersensitivity to testosterone or excipients of Nebido
Who cannot join
- Androgen dependent carcinoma of the prostate or male mammary gland, past or present history of liver tumours, hypersensitivity towards the active pharmaceutical ingredient or other ingredients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nebido® Therapy in Hypogonadal Male Patients With Osteoporosis Associated With Paraplegia Compared With Conventional Osteoporosis - Prophylaxis / Therapy in Hypogonadal and Eugonadal Patients With Osteoporosis Associated With Paraplegia
Both conditions hypogonadism and immobilisation (paraplegia) may contribute or lead to decreased bone mineral density resp osteoporosis. In this study bone mineral density is assessed in hypogonadal paraplegic patients, who are on standard prophylactic therapy for osteoporosis and and on a standard physiotherapy exercise program one group receiving Nebido for testosterone replacement (TRT). The additional effect of TRT on bone mineral density / osteoporosis is assessed (CT scan lumbar spine).
- Conditions
- Hypogonadism, Paraplegia, Bone Density, Osteoporosis
- Being tested
- Testosterone Undeconate (Nebido-R, BAY86-5037)
- Keywords
- Testosterone replacement therapy, Hypogonadism, Osteoporosis, Immobilisation, Paraplegia, Testosterone
- Medical subject headings
- Hypogonadism, Paraplegia, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Undeconate (Nebido-R, BAY86-5037)Drug
Male patients > 18yrs in medical practices fulfilling all criteria for documentation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Testosterone Undeconate (Nebido-R, BAY86-5037) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density (CT lumbar spine)
Measured: 12 weeks after 4th injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startSep 2005
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838838
- Sponsor's protocol ID
- 13900
- Other IDs
- NE0501
- Status last verified
- Apr 2010
- First submitted
- 4 Feb 2009
- Last updated
- 14 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebido® Therapy in Hypogonadal Male Patients With Osteoporosis Associated With Paraplegia Compared With Conventional Osteoporosis - Prophylaxis / Therapy in Hypogonadal and Eugonadal Patients With Osteoporosis Associated With Paraplegia
- ClinicalTrials.gov ID
- NCT00838838
- Acronym / sponsor ID
- 13900
- Conditions
- Hypogonadism, Paraplegia, Bone Density, Osteoporosis
- Keywords
- Testosterone replacement therapy, Hypogonadism, Osteoporosis, Immobilisation, Paraplegia, Testosterone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Both conditions hypogonadism and immobilisation (paraplegia) may contribute or lead to decreased bone mineral density resp osteoporosis. In this study bone mineral density is assessed in hypogonadal paraplegic patients, who are on standard prophylactic therapy for osteoporosis and and on a standard physiotherapy exercise program one group receiving Nebido for testosterone replacement (TRT). The additional effect of TRT on bone mineral density / osteoporosis is assessed (CT scan lumbar spine).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Testosterone Undeconate (Nebido-R, BAY86-5037) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients > 18yrs in medical practices fulfilling all criteria for documentation.
Key inclusion criteria (13 listed)
- Male patients > 18yrs
- Osteoporosis prophylaxis/therapy with
- Standardised physiotherapy exercise programme.
- No proliferative bone disease.
- No history of calcium oxalate stones.
Key exclusion criteria (1 listed)
- Androgen dependent carcinoma of the prostate or male mammary gland, past or present history of liver tumours, hypersensitivity towards the active pharmaceutical ingredient or other ingredients.
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 |
|---|---|---|
| Testosterone Undeconate (Nebido-R, BAY86-5037)Male patients > 18yrs in medical practices fulfilling all criteria for documentation. | Drug | Group 1 |
Primary outcome
Bone mineral density (CT lumbar spine)
Time frame: 12 weeks after 4th injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2010.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypogonadism and Paraplegia, run by Bayer at 1 site in Germany.
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 13 inclusion and 1 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: finished, as of the sponsor's last update on 14 Apr 2010. 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 Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bone mineral density (CT lumbar spine) (time frame: 12 weeks after 4th injection). 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 14 Apr 2010.