Status:
COMPLETED
Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis
Lead Sponsor:
Bayer
Conditions:
Hypogonadism
Paraplegia
Eligibility:
MALE
18+ years
Brief 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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00838838
Start Date
September 1 2005
End Date
May 1 2009
Last Update
April 14 2010
Active Locations (1)
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1
Many Locations, Germany