Trial Condition(s):
Hypogonadism, Paraplegia, Bone Density, Osteoporosis
Efficacy of Nebido on bone mineral density (BMD) in hypogonadal paraplegic patients with confirmed osteoporosis
Bayer Identifier:
13900
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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).
Inclusion Criteria
- 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. - 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
Exclusion Criteria
- 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 Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Germany | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Bone mineral density (CT lumbar spine)Timeframe: 12 weeks after 4th injection
Additional Information
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