Maintaining Bone Strength in Men With Prostate Cancer

Novartis

Status and phase

Terminated

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: Zoledronic acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT00391950

CZOL446GGB12

Details and patient eligibility

About

The purpose of this study is to see if giving zoledronic acid three times a year is as effective as five times a year, in increasing bone strength in men with prostate cancer. All participants will receive the active drug but half will receive drug every 6 months and the other half will receive drug every 3 months. Both patient and doctor will know which treatment a patient is receiving.

After 1 year of treatment bone strength will be measured with scans and compared to the strength at the start of the study. All participants will stop receiving the drug after 1 year and will be seen back in the clinic, annually for another 2 years for follow-up.

Enrollment

300 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed diagnosis of carcinoma of the prostate

No distant metastases
Patients must be candidates for androgen deprivation therapy (ADT)
Patient with a baseline BMD T-score at or below -1 standard deviations in the lumbar spine (L2-L4) are eligible

Exclusion criteria

Patients with normal BMD at trial entry

Patients who received any prior bisphosphonate therapy in the past 12 months
Treatment with anti-androgen mono- or combination therapy
Patients who are currently receiving diethylstilbesterol (DES) or who have previously received PC-SPES
Patients who have received prior treatment with systemic corticosteroids within the past 12 months
Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months
Patients with any prior treatment for osteoporosis

Other protocol-defined inclusion/exclusion criteria may apply.