Study Completed

Hypogonadism, Paraplegia, Bone Density, Osteoporosis

Bayer Identifier:

13900

ClinicalTrials.gov Identifier:

NCT00838838

EudraCT Number:

Not Available

EU CT Number:

Not Available

Efficacy of Nebido on bone mineral density (BMD) in hypogonadal paraplegic patients with confirmed osteoporosis

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).

Key Participants Requirements

Sex

Male

Age

18 Years

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

September 2005 - May 2009

Phase

N/A

Could I Receive a placebo

Products

Nebido (Testosterone Undeconate, BAY86-5037)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Germany

Primary Outcome

Bone mineral density (CT lumbar spine)
Time Frame:
12 weeks after 4th injection
Safety Issue:
No

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

N/A

Additional Information

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