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Sponsors and Collaborators: |
Massachusetts General Hospital Dana-Farber Cancer Institute |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00181584 |
The primary objective of this study is to determine whether zoledronic acid (Zometa) given once annually increases bone mineral density in men receiving hormone therapy for prostate cancer.
Condition | Intervention | Phase |
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Bone Loss Prostate Cancer |
Drug: Zoledronic acid Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer |
Enrollment: | 60 |
Study Start Date: | September 2003 |
Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Active Comparator |
Drug: Zoledronic acid
Given intravenously once.
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Group 2: Placebo Comparator |
Other: Placebo
Given intravenously once.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Matthew Smith, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hosptial ( Matthew Smith, MD, PhD ) |
Study ID Numbers: | 03-194 |
Study First Received: | September 9, 2005 |
Last Updated: | December 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00181584 History of Changes |
Health Authority: | United States: Institutional Review Board |
Androgen deprivation therapy bone loss prostate cancer Zoledronic Acid Zometa |
Diphosphonates Zoledronic acid Prostatic Diseases Genital Neoplasms, Male Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
Bone Density Conservation Agents Urogenital Neoplasms Genital Diseases, Male Hormones Prostatic Neoplasms Androgens |
Zoledronic acid Genital Neoplasms, Male Prostatic Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Urogenital Neoplasms Genital Diseases, Male |
Hormones Pharmacologic Actions Neoplasms Neoplasms by Site Diphosphonates Prostatic Neoplasms Androgens |