Maintaining Bone Strength in Men With Prostate Cancer
Phase 3
Terminated
- Conditions
- Prostate Cancer
- Registration Number
- NCT00391950
- Lead Sponsor
- Novartis
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in bone mineral density (BMD) at lumbar spine as assessed by dual energy x-ray absoptiometry (DEXA) scan
- Secondary Outcome Measures
Name Time Method To compare the effect of zoledronic acid 4 mg every 12 weeks versus every 24 weeks on: The percent change in BMD of the total hip following one year of therapy and the forearm following one year of therapy. This will be carried out at a limited number of centres. Quality of life following one year of therapy. Various biochemical markers of bone resorption (N-telopeptide, NTX, C-telopeptide, CTX, TRACP, PINP) and bone formation (bone alkaline phosphatase, BAP) during one year of therapy. This will be carried out at a limited number of centres. Percentage of and rate of vertebral and hip fractures. Safety and tolerability