Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Natural history/Epidemiology, Prevention	Active	Not specified	NCI, Pharmaceutical / Industry	GOG-0215 0215, NOVARTIS-GOG-0215, NCI-06-C-0204, NCI-P6966, NCT00305695

Special Category: NCI Web site featured trial

Objectives

Primary

1. 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.

Secondary

1. Compare the change in bone mineral density of the bilateral hip in patients treated with these regimens.

Tertiary

1. 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.

Entry Criteria

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
  • 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

Prior/Concurrent Therapy:

• No recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction or implants)
• No prior treatment for osteoporosis
• No adjuvant radiotherapy within the past 31 days
• No chemotherapy within the past 30 days
• No prior surgery to the hip or spine
• No prior systemic sodium fluoride for > 3 months during the past 2 years
• No more than 30 days use in the past 12 months and no concurrent tamoxifen, raloxifene, or any other selective estrogen-receptor modulator (SERM)
• More than 12 months since prior and no concurrent endocrine therapy
  • Insulin and/or oral antidiabetic medications allowed
  • Thyroid hormone replacement allowed
• More than 12 months since prior and no concurrent estrogen or hormone replacement therapy (estrogen plus progesterone or estrogen alone)
  • Prior or concurrent oral contraceptives allowed
  • Systemic (oral) hormone replacement therapy following surgery not allowed
    • Vaginal (non-systemic) estrogen allowed
• More than 12 months since prior and no concurrent oral or IV bisphosphonate
• More than 12 months since prior and no concurrent anabolic steroids or growth hormone
• More than 12 months since prior and no concurrent systemic corticosteroids
  • Concurrent short term corticosteroid therapy (to prevent/treat chemotherapy-induced nausea/vomiting) allowed
• More than 6 months since prior and no concurrent Tibolone
• More than 2 weeks since prior and no concurrent drugs known to affect the skeleton (e.g., calcitonin, mithramycin, or gallium nitrate)
• No concurrent chemotherapy or radiotherapy
• No concurrent aromatase inhibitors
• Concurrent enrollment on protocol GOG-0199 allowed

Patient Characteristics:

• Premenopausal*
  • Last menstrual cycle occurred < 12 months prior to study enrollment

   [Note: *In unclear cases premenopausal status may be determined by follicle stimulating hormone level AND must be ≤ 20 U/L]

• 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:
  • Paget’s disease
  • Osteogenesis imperfecta
  • Uncontrolled thyroid or parathyroid dysfunction within 12 months prior to study entry
• No other nonmalignant systemic disease, including any of the following:
  • Uncontrolled infection
  • Uncontrolled type 2 diabetes mellitus
  • Cardiovascular, renal, hepatic, or lung disease that would prevent prolonged follow-up
    • History of thrombosis or thromboembolism allowed
• No known HIV positivity
• No known hypersensitivity to zoledronate or other bisphosphonates
• No psychiatric, psychological, or other conditions that prevent fully informed consent
• No other active malignancy except nonmelanoma skin cancer
• No history of any medical condition that places the patient at risk for donating blood for research purposes (e.g., chronic infectious diseases, sever anemia, or hemophilia)
• Not pregnant
• Negative pregnancy test
• No current active dental problems, including any of the following:
  • Infection of the teeth or jawbone (maxilla or mandible)
  • Dental or fixture trauma
  • Current or prior diagnosis of osteonecrosis of the jaw
  • Exposed bone in the mouth
  • Slow healing after dental procedures

Expected Enrollment

A total of 222 patients will be accrued for this study.

Outcomes

Bone mineral density of the lumbar spine as measured by dual-energy x-ray absorptiometry (DEXA) scan at baseline (may be before surgery) and 9 and 18 months after surgery

Bone mineral density of the total hip as measured by DEXA scan at baseline (may be before surgery) and 9 and 18 months after surgery

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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

David Alberts, MD, Protocol chair		Ph: 520-626-7685; 800-622-2673
Larissa Korde, MD, MPH, Protocol co-chair		Ph: 301-402-2183
Gus Rodriguez, MD, Protocol co-chair		Ph: 847-570-2639; 888-909-5222 Email: grodriguez@enh.org
Lisa Hess, MA, MSC, Protocol co-chair		Ph: 520-626-1387; 800-622-2673

U.S.A.
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Tucson
	Arizona Cancer Center at University of Arizona Health Sciences Center
		Clinical Trials Office - Arizona Cancer Center at University of Arizona Health Sciences Center	Ph:  520-626-9008
California
	Burbank
	Providence Saint Joseph Medical Center - Burbank
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - City of Hope Comprehensive Cancer Center	Ph:  800-826-4673
			Email: becomingapatient@coh.org
	La Jolla
	Rebecca and John Moores UCSD Cancer Center
		Clinical Trials Office - Rebecca and John Moores UCSD Cancer Center	Ph:  858-822-5354
			Email: cancercto@ucsd.edu
	Los Angeles
	Kaiser Permanente Medical Center - Los Angeles
		Scott Lentz, MD	Ph:  323-783-4018
	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
		Ilana Cass	Ph:  310-423-3277
	Stanford
	Stanford Cancer Center
		Clinical Trials Office - Stanford Cancer Center	Ph:  650-498-7061
			Email: cctoffice@stanford.edu
Colorado
	Aurora
	Colorado Gynecologic Oncology Group, PC
		Susan Davidson, MD	Ph:  303-315-7897
	Boulder
	Boulder Community Hospital
		Clinical Trials Office - Boulder Community Hospital	Ph:  303-938-5253
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Clinical Trials Office - Penrose Cancer Center	Ph:  719-776-5275
	Denver
	CCOP - Colorado Cancer Research Program
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Rose Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	St. Joseph Hospital
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Greeley
	North Colorado Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Loveland
	McKee Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Thornton
	North Suburban Medical Center
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Wheat Ridge
	Exempla Lutheran Medical Center
		Clinical Trials Office - Exempla Lutheran Medical Center	Ph:  303-403-3605
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Clinical Trials Office - Tunnell Cancer Center	Ph:  302-645-3171
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-733-6227
District of Columbia
	Washington
	Washington Cancer Institute at Washington Hospital Center
		Clinical Trials Office - Washington Cancer Institute	Ph:  202-877-8839
Florida
	Fort Lauderdale
	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
		Clinical Trials Office - Michael and Dianne Bienes Comprehensive Cancer Center	Ph:  954-776-3239
	Orlando
	M.D. Anderson Cancer Center at Orlando
		Alan Gordon	Ph:  407-648-3800 800-648-3818
Hawaii
	Honolulu
	Tripler Army Medical Center
		Bradford Whitcomb	Ph:  808-433-4089
Illinois
	Evanston
	Evanston Hospital
		Clinical Trials Office - Evanston Hospital	Ph:  847-570-1381
	Winfield
	Central Dupage Cancer Center
		Laura Horvath	Ph:  630-933-1600
Indiana
	Indianapolis
	Indiana University Melvin and Bren Simon Cancer Center
		Clinical Trials Office - Indiana University Cancer Center	Ph:  317-274-2552
	St. Vincent Indianapolis Hospital
		Clinical Trials Office - St. Vincent Indianapolis Hospital	Ph:  317-338-2194
Kentucky
	Lexington
	Central Baptist Hospital
		Clinical Trials Office - Central Baptist Hospital	Ph:  859-260-6425
	Louisville
	Louisville Oncology at Norton Cancer Institute - Louisville
		Clinical Trials Office - Louisville Oncology	Ph:  502-629-2500
Maryland
	Baltimore
	Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
		Clinical Trials Office - Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center	Ph:  443-777-7364
	Elkton MD
	Union Hospital Cancer Program at Union Hospital
		Mark Borowsky	Ph:  410-398-4000
Michigan
	Kalamazoo
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
Minnesota
	Minneapolis
	Masonic Cancer Center at University of Minnesota
		Clinical Trials Office - Masonic Cancer Center at University of Minnesota	Ph:  612-624-2620
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Missouri
	Kansas City
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Louis
	CCOP - St. Louis-Cape Girardeau
		Bethany Sleckman, MD	Ph:  314-251-7057
	David C. Pratt Cancer Center at St. John's Mercy
		Clinical Trials Office - David C. Pratt Cancer Center at St. John's Mercy	Ph:  314-251-6770
	Springfield
	St. John's Regional Health Center
		Robert Carolla	Ph:  417-820-2000
Nevada
	Las Vegas
	Women's Cancer Center - Lake Mead
		Nick Spirtos, MD	Ph:  408-866-3843
	Reno
	Renown Institute for Cancer at Renown Regional Medical Center
		Peter Lim	Ph:  775-982-5050 866-559-0558
New Jersey
	Marlton
	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
		Clinical Trials Office - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Ph:  888-847-8823
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees	Ph:  856-325-6757
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Center	Ph:  505-272-6972
New York
	Manhasset
	Don Monti Comprehensive Cancer Center at North Shore University Hospital
		Clinical Trials Office - Don Monti Comprehensive Cancer Center at North Shore University Hospital	Ph:  516-734-8900
	New York
	Mount Sinai Medical Center
		Linus Chuang	Ph:  212-241-6500
	NYU Cancer Institute at New York University Medical Center
		Stephanie Blank, MD	Ph:  212-263-2668
North Carolina
	Burlington
	Alamance Cancer Center at Alamance Regional Medical Center
		Janak Choksi, MD	Ph:  336-538-7737
	Pinehurst
	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
		Clinical Trials Office - FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center	Ph:  910-715-2200
Ohio
	Cincinnati
	Charles M. Barrett Cancer Center at University Hospital
		William Richards	Ph:  806-796-1317
	Good Samaritan Hospital Cancer Treatment Center
		Jack Basil, MD	Ph:  513-872-3401
	Cleveland
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph:  800-641-2422
	Columbus
	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph:  866-627-7616
			Email: osu@emergingmed.com
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
	Mentor
	Lake/University Ireland Cancer Center
		Steven Waggoner, MD	Ph:  216-844-5011
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Robert Mannel, MD	Ph:  405-271-8787
	Tulsa
	Cancer Care Associates - Saint Francis Campus
		Robert Mannel, MD	Ph:  405-271-8787
Oregon
	Portland
	Knight Cancer Institute at Oregon Health and Science University
		Clinical Trials Office - Knight Cancer Institute at Oregon Health and Science University	Ph:  503-494-1080
			Email: trials@ohsu.edu
Pennsylvania
	Bryn Mawr
	Bryn Mawr Hospital
		Clinical Trials Office - Bryn Mawr Hospital	Ph:  610-645-2680
	Paoli
	Cancer Center of Paoli Memorial Hospital
		Clinical Trials Office - Cancer Center of Paoli Memorial Hospital	Ph:  610-648-1637
	Wynnewood
	Lankenau Cancer Center at Lankenau Hospital
		Contact Person	Ph:  610-645-2000
Rhode Island
	Providence
	Women and Infants Hospital of Rhode Island
		Clinical Trials Office - Women and Infants Hospital of Rhode Island	Ph:  401-274-1122
Tennessee
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  800-811-8480
Vermont
	Burlington
	Fletcher Allen Health Care - University Health Center Campus
		Clinical Trials Office - Fletcher Allen Health Care	Ph:  802-656-8990
Virginia
	Charlottesville
	University of Virginia Cancer Center
		Susan Modesitt	Ph:  434-924-9333 800-223-9173
	Richmond
	Virginia Commonwealth University Massey Cancer Center
		Clinical Trials Office -Virginia Commonwealth University Massey Cancer Center	Ph:  804-628-1939
	Roanoke
	Carilion Gynecologic Oncology Associates
		Natalie Gould	Ph:  540-345-8574 800-422-8482
Wisconsin
	Green Bay
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889

Related Information

PDQ® clinical trial GOG-0199
Website for additional information
Featured trial article

Registry Information
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
Trial Start Date		2005-11-28
Trial Completion Date		2013-03-31 (estimated)
Registered in ClinicalTrials.gov		NCT00305695
Date Submitted to PDQ		2005-12-13
Information Last Verified		2009-11-21
NCI Grant/Contract Number		CA101165

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