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Completed

NCT Number: NCT00838838

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

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).

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Key information

Conditions

Hypogonadism Bone Density Bone Diseases Bone Diseases, Metabolic Endocrine System Diseases Gonadal Disorders Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Osteoporosis Paralysis Paraplegia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testosterone Undeconate (Nebido-R, BAY86-5037)

Drug

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

Primary outcomes

  1. Bone mineral density (CT lumbar spine)

    Time frame: 12 weeks after 4th injection

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Feb 6, 2009
Registry last updated
Apr 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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