Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation
NCT00058188 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2020-12-08
Summary
RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss.
PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
cholecalciferol
Given orally
- DRUG
-
calcium gluconate
Given orally
- DRUG
-
zoledronic acid
Given IV
Sponsors & Collaborators
- collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
Charles L. Bennett, MD, PhD · Robert H. Lurie Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-03-31
- Primary Completion
- 2008-11-30
- Completion
- 2008-11-30
Countries
- United States
Study Locations
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