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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838838
• Other study ID #: 13900
• Secondary ID: NE0501
• Status: Completed
• Phase: N/A
• First received: February 4, 2009
• Last updated: April 13, 2010
• Start date: September 2005
• Est. completion date: May 2009

Study information

• Verified date: April 2010
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Density
• Hypogonadism
• Osteoporosis
• Paraplegia

Intervention

Drug:
• Testosterone Undeconate (Nebido-R, BAY86-5037)
Male patients > 18yrs in medical practices fulfilling all criteria for documentation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density (CT lumbar spine)		12 weeks after 4th injection	No

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