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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00838838
First received: February 4, 2009
Last updated: April 13, 2010
Last verified: April 2010
History of Changes
  Purpose

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
Hypogonadism
Paraplegia
Bone Density
Osteoporosis
 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:

U.S. FDA Resources

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.

  Eligibility

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.

Criteria

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

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

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

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
Hypogonadism
Osteoporosis
 Immobilisation
Paraplegia
Testosterone

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

ClinicalTrials.gov processed this record on June 18, 2013