Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries
|ClinicalTrials.gov Identifier: NCT00305695|
Recruitment Status : Active, not recruiting
First Posted : March 22, 2006
Last Update Posted : August 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hereditary Breast and Ovarian Cancer Syndrome Osteoporosis Ovarian Carcinoma||Other: Laboratory Biomarker Analysis Drug: Zoledronic Acid||Phase 2|
I. Compare the effect of zoledronate vs observation on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries) in patients undergoing excision of both ovaries.
I. Compare the change in bone mineral density of the bilateral hip in patients treated with these regimens.
I. Compare the effect of zoledronate vs observation on biochemical markers of bone resorption and bone formation (N-telopeptide and bone specific alkaline phosphatase) during 1 year of treatment.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
All patients undergo surgery, with removal of both ovaries, in month 1. All patients are requested to take calcium supplements twice daily and a multivitamin containing vitamin D once daily beginning in month 1 and continuing for up to 18 months.
ARM I: Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
ARM II: Patients are observed for 18 months after surgery.
In both arms, patients complete physical activity questionnaires at baseline and in months 3, 9, 15, and 18. Patients undergo bone mineral density test of lumbar spine and total hip at baseline and in months 9 and 18. Patients also undergo blood collection at baseline and periodically during the study for biomarker studies.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Actual Study Start Date :||November 28, 2005|
|Primary Completion Date :||December 22, 2011|
U.S. FDA Resources
Experimental: Arm I (zoledroic acid)
Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
Other: Laboratory Biomarker Analysis
Correlative studiesDrug: Zoledronic Acid
No Intervention: Arm II (clinical observation)
Patients are observed for 18 months after surgery.
- Bone mineral density of the lumbar spine as measured by dual-energy x-ray absorptiometry (DEXA) scan [ Time Frame: Up to 18 months ]
- Bone mineral density of the total hip as measured by DEXA scan [ Time Frame: Up to 18 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305695
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|Principal Investigator:||David Alberts||Gynecologic Oncology Group|