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

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ClinicalTrials.gov Identifier: NCT00838838
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : April 14, 2010
Sponsor:
Information provided by:

Study Description
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).

Condition or disease Intervention/treatment
Hypogonadism Paraplegia Bone Density Osteoporosis Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)

Study Design

Study Type : Observational
Actual Enrollment : 26 participants
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
Study Start Date : September 2005
Primary Completion Date : May 2009
Study Completion Date : May 2009


Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1 Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)
Male patients > 18yrs in medical practices fulfilling all criteria for documentation.


Outcome Measures

Primary Outcome Measures :
  1. Bone mineral density (CT lumbar spine) [ Time Frame: 12 weeks after 4th injection ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838838


Locations
Germany
Many Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
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
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: April 14, 2010
Last Verified: April 2010

Keywords provided by Bayer:
Testosterone replacement therapy
Hypogonadism
Osteoporosis
Immobilisation
Paraplegia
Testosterone

Additional relevant MeSH terms:
Paraplegia
Osteoporosis
Hypogonadism
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Gonadal Disorders
Endocrine System 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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents