Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries
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
7 other identifiers
interventional
160
1 country
95
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 28, 2005
CompletedFirst Submitted
Initial submission to the registry
March 21, 2006
CompletedFirst Posted
Study publicly available on registry
March 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2011
CompletedResults Posted
Study results publicly available
March 24, 2020
CompletedMarch 24, 2020
March 1, 2020
6.1 years
March 21, 2006
March 9, 2020
March 9, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 9 Months
To compare the effect of zoledronic acid administered every 6 months on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries), as compared with observation alone. This is to be evaluated by measuring the change from baseline to 9 months in bone mineral density (BMD) of the lumbar spine, specifically L1-L4 dual energy X-ray absorptiometry (DEXA).
9 Months
Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 18 Months
To compare the effect of zoledronic acid administered every 6 months on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries), as compared with observation alone. This is to be evaluated by measuring the change from baseline to 18 months in bone mineral density (BMD) of the lumbar spine, specifically L1-L4 dual energy X-ray absorptiometry (DEXA).
18 months
Bone Mineral Density of the Total Hip as Measured by DEXA Scan on Right Hip
To compare the effect of zoledronic acid on the change in BMD of the right hip following treatment, evaluated by measuring the change from baseline to 18 months
18 months
Bone Mineral Density of the Total Hip as Measured by DEXA Scan on Left Hip
To compare the effect of zoledronic acid on the change in BMD of the left hip following treatment, evaluated by measuring the change from baseline to 18 months
18 months
Study Arms (2)
Arm I (zoledroic acid)
EXPERIMENTALBeginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
Arm II (clinical observation)
NO INTERVENTIONPatients are observed for 18 months after surgery.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- 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
- Patients enrolled in the screening arm of GOG-0199 who decide to undergo surgery are potentially eligible for GOG-0215
- Baseline bone mass density (BMD) T-Score ? -1.5 (no more than 1.5 standard deviation below the mean value for young adults) on both the total lumbar spine (L1-L4 region, not individual bones) and bilateral hip
- Patients who had/have at least 1 intact ovary at the time of surgery are eligible
- No prior distant metastatic malignant disease within the past 5 years
- Patients treated for stage M1 (any T, any N) diagnosis in the past 5 years are ineligible
- Patients who achieved a complete response after treatment for rM0 (any T, any N) within the past 5 years are eligible
- Premenopausal\*
- Last menstrual cycle occurred \< 12 months prior to study enrollment
- GOG performance status 0-2
- Creatinine clearance \> 60 mL/min
- No clinical or radiological evidence of existing fracture of the lumbar spine or bilateral hip
- No history of hip of spine fracture with low-intensity trauma or not associated with trauma
- No uncontrolled seizure disorder associated with falls
- No diseases that influence bone metabolism, including any of the following:
- +44 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (95)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
University of California San Diego
San Diego, California, 92103, United States
Colorado Gynecologic Oncology Group
Aurora, Colorado, 80010, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Yale University
New Haven, Connecticut, 06520, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
UF Cancer Center at Orlando Health
Orlando, Florida, 32806, United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859, United States
University of Illinois
Chicago, Illinois, 60612, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, 60190, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46260, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Saint Luke's South Hospital
Overland Park, Kansas, 66213, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, 40202, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Truman Medical Center
Kansas City, Missouri, 64108, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, 64118, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64507, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, 63141, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
Center of Hope at Renown Medical Center
Reno, Nevada, 89502, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Main Line Health NCORP
Wynnewood, Pennsylvania, 19096, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, 37403, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Linda Gedeon on behalf of James Kauderer, MA, BS
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
David S Alberts
Gynecologic Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2006
First Posted
March 22, 2006
Study Start
November 28, 2005
Primary Completion
December 22, 2011
Last Updated
March 24, 2020
Results First Posted
March 24, 2020
Record last verified: 2020-03