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

Completed

• Conditions: Hypogonadism; Paraplegia; Bone Density; Osteoporosis
• Interventions: Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)

• Registration Number: NCT00838838
• Lead Sponsor: Bayer

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).

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2009-02-04
• Study First Submitted QC: 2009-02-05
• Study First Posted: 2009-02-06
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-13
• Last Update Posted: 2010-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

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

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Testosterone Undeconate (Nebido-R, BAY86-5037)	-

Primary Outcome Measures

Name	Time	Method
Bone mineral density (CT lumbar spine)	12 weeks after 4th injection