Status:
TERMINATED
Maintaining Bone Strength in Men With Prostate Cancer
Lead Sponsor:
Novartis
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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 re...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00391950
Start Date
October 1 2006
Last Update
November 23 2009
Active Locations (1)
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1
Derby, United Kingdom