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

Bayer

Status: Completed

Conditions: Osteoporosis; Hypogonadism; Bone Density; Paraplegia

Treatments: Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)

Study type: Observational

Funder types: Industry

Identifiers

NCT00838838

13900

NE0501

Details and patient eligibility

About

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).

Enrollment: 26 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.

Trial design

26 participants in 1 patient group

Group 1

Treatment:

Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)