CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 160 enrolled
Drug / intervention
Zoledronic Acid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00305695
NCT00305695Phase 2Completed
CompareCT.gov

A Phase II Randomized Study of the Effect of Zoledronic Acid Versus Observation on Bone Mineral Density of the Lumbar Spine in Women Who Elect to Undergo Surgery That Results in Removal of Both Ovaries

Gynecologic Oncology Group·interventional·Posted Mar 22, 2006·Updated Mar 24, 2020

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis and Zoledronic Acid for Hereditary Breast and Ovarian Cancer Syndrome and 2 related conditions. Completed, enrolled 160 participants across 95 sites.

Detailed Summary

This randomized phase II trial is studying zoledronate to see how well it works compared to observation in maintaining bone mineral density in patients who are undergoing surgery to remove both ovaries. Zoledronate may prevent bone loss in patients who are undergoing surgery to remove the ovaries.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Breast and Ovarian Cancer Syndrome, Osteoporosis, Ovarian Carcinoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 22, 2006
Enrollment StartNov 28, 2005
Primary CompletionDec 22, 2011
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 20.3 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Zoledronic Aciddrug

Given IV