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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00838838

Enrollment

Registered

2009-02-06

Start date

2005-09-30

Completion date

2009-05-31

Last updated

2010-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Density, Hypogonadism, Osteoporosis, Paraplegia

Keywords

Testosterone replacement therapy, Hypogonadism, Osteoporosis, Immobilisation, Paraplegia, Testosterone

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).

Interventions

DRUGTestosterone Undeconate (Nebido-R, BAY86-5037)

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Bone mineral density (CT lumbar spine)	12 weeks after 4th injection

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026