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

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Brief Title

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

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

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).
    



Study Type

Observational


Primary Outcome

Bone mineral density (CT lumbar spine)


Condition

Hypogonadism

Intervention

Testosterone Undeconate (Nebido-R, BAY86-5037)

Study Arms / Comparison Groups

 Group 1
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

26

Start Date

September 2005

Completion Date

May 2009

Primary Completion Date

May 2009

Eligibility 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.
      

Gender

Male

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Bayer Study Director, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT00838838

Organization ID

13900

Secondary IDs

NE0501


Study Sponsor

Bayer


Study Sponsor

Bayer Study Director, Study Director, Bayer


Verification Date

April 2010