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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: February 4, 2009
Last updated: April 13, 2010
Last verified: April 2010
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).

Condition Intervention
Bone Density
Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Bone mineral density (CT lumbar spine) [ Time Frame: 12 weeks after 4th injection ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: September 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)
Male patients > 18yrs in medical practices fulfilling all criteria for documentation.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male patients > 18yrs in medical practices fulfilling all criteria for documentation.

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00838838

Many Locations, Germany
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Medical Director, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00838838     History of Changes
Other Study ID Numbers: 13900  NE0501 
Study First Received: February 4, 2009
Last Updated: April 13, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Testosterone replacement therapy

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Metabolic
Endocrine System Diseases
Gonadal Disorders
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 02, 2016