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

NCT00838838 | Completed

• 2 other identifiers: 13900NE0501
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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

Keywords

Testosterone replacement therapy; Hypogonadism; Osteoporosis; Immobilisation; Paraplegia; Testosterone

Outcome Measures

Primary Outcomes (1)

• Bone mineral density (CT lumbar spine)

  12 weeks after 4th injection

Study Arms (1)

Group 1

Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)

Interventions

Testosterone Undeconate (Nebido-R, BAY86-5037) DRUG

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

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Germany

Location

MeSH Terms

Conditions

Hypogonadism; Paraplegia; Osteoporosis

Interventions

Testosterone Propionate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Testosterone; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 4, 2009
• First Posted: February 6, 2009
• Study Start: September 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: April 14, 2010

Record last verified: 2010-04

Locations

DE (1)