Maintaining Bone Strength in Men With Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00391950|
Recruitment Status : Terminated
First Posted : October 25, 2006
Last Update Posted : November 23, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Zoledronic acid||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Randomized, Multicentre Study to Evaluate the Efficacy of Two Zoledronic Acid Schedules on Bone Mineral Density in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy|
|Study Start Date :||October 2006|
|Primary Completion Date :||May 2007|
- Change in bone mineral density (BMD) at lumbar spine as assessed by dual energy x-ray absoptiometry (DEXA) scan
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391950
|Derby, United Kingdom|