Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis

NCT ID: NCT00838838

Last Updated: 2010-04-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2009-05-31

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 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Testosterone Undeconate (Nebido-R, BAY86-5037)

Intervention Type: DRUG

Male patients \> 18yrs in medical practices fulfilling all criteria for documentation.

Interventions

Testosterone Undeconate (Nebido-R, BAY86-5037)

Male patients \> 18yrs in medical practices fulfilling all criteria for documentation.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer Schering Pharma AG

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Many Locations, , Germany

Countries

Germany

Other Identifiers

NE0501

Identifier Type: -

Identifier Source: secondary_id

13900

Identifier Type: -

Identifier Source: org_study_id