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Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00391950 |
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 | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: Zoledronic acid |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 300 |
Study Start Date: | October 2006 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Histologically confirmed diagnosis of carcinoma of the prostate
Exclusion criteria:
Patients with normal BMD at trial entry
Other protocol-defined inclusion/exclusion criteria may apply.
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CZOL446GGB12 |
Study First Received: | October 23, 2006 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00391950 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Prostate cancer Cancer treatment induced bone loss (CTIBL) Androgen deprivation therapy (ADT) |
Zoledronic acid Prostatic Diseases Genital Neoplasms, Male Bone Density Conservation Agents |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Androgens |
Neoplasms Zoledronic acid Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male Physiological Effects of Drugs |
Bone Density Conservation Agents Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Pharmacologic Actions |