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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00305695 |
RATIONALE: Zoledronate may prevent bone loss in patients who are undergoing surgery to remove the ovaries.
PURPOSE: 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.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Hereditary Breast/Ovarian Cancer (brca1, brca2) Ovarian Cancer |
Drug: zoledronic acid Procedure: observation |
Phase II |
Study Type: | Observational |
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 |
Estimated Enrollment: | 222 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Arm I
Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
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Drug: zoledronic acid
Given IV
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Arm II
Patients are observed for 18 months after surgery.
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Procedure: observation
Patients are observed for 18 months after surgery.
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OBJECTIVES:
Primary
Secondary
Tertiary
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.
PROJECTED ACCRUAL: A total of 222 patients will be accrued for this study.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients who have elected to undergo, or who have undergone (within 8 weeks) a surgical procedure that results (at minimum) in the absence of both ovaries
No prior distant metastatic malignant disease within the past 5 years
PATIENT CHARACTERISTICS:
Premenopausal*
No diseases that influence bone metabolism, including any of the following:
No other nonmalignant systemic disease, including any of the following:
Cardiovascular, renal, hepatic, or lung disease that would prevent prolonged follow-up
No current active dental problems, including any of the following:
PRIOR CONCURRENT THERAPY:
More than 12 months since prior and no concurrent endocrine therapy
More than 12 months since prior and no concurrent estrogen or hormone replacement therapy (estrogen plus progesterone or estrogen alone)
Systemic (oral) hormone replacement therapy following surgery not allowed
More than 12 months since prior and no concurrent systemic corticosteroids
Study Chair: | David S. Alberts, MD | University of Arizona |
Investigator: | Larissa Korde, MD, MPH | National Cancer Institute (NCI) |
Investigator: | Gus Rodriguez, MD | Evanston Northwestern Healthcare - Evanston Hospital |
Investigator: | Lisa M. Hess, MA, MSC | University of Arizona |
Study ID Numbers: | CDR0000462217, GOG-0215, NOVARTIS-GOG-0215, NCI-06-C-0204, NCI-P6966 |
Study First Received: | March 21, 2006 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00305695 |
Health Authority: | Unspecified |
osteoporosis hereditary breast/ovarian cancer (BRCA1, BRCA2) ovarian epithelial cancer |
Ovarian cancer Ovarian Neoplasms Zoledronic acid Gonadal Disorders Genital Neoplasms, Female Osteoporosis Endocrine System Diseases |
Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Genital Diseases, Female Endocrinopathy Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Physiological Effects of Drugs |
Bone Density Conservation Agents Pharmacologic Actions Adnexal Diseases |