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 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.
California
	Burbank
	Providence Saint Joseph Medical Center - Burbank
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
	Los Angeles
	Kaiser Permanente Medical Center - Los Angeles
		Scott Lentz, MD	Ph:  323-783-4018
	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
	Denver
	CCOP - Colorado Cancer Research Program
		Eduardo Pajon, MD	Ph:  303-399-8020ext2261
	Rose 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
Connecticut
	New Britain
	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
		Clinical Trials Office - George Bray Cancer Center	Ph:  860-224-5660
	New Haven
	Yale Cancer Center
		Clinical Trials Office - Yale Cancer Center	Ph:  203-785-5702
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
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
	Jupiter
	Ella Milbank Foshay Cancer Center at Jupiter Medical Center
		Clinical Trials Office - Ella Milbank Foshay Cancer Center	Ph:  561-745-5768
	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
	Chicago
	University of Illinois Cancer Center
		Clinical Trial Office - University of Illinois Cancer Center	Ph:  312-355-3046
	Evanston
	Evanston Northwestern Healthcare - Evanston Hospital
		Clinical Trials Office - Evanston Northwestern Healthcare - Evanston Hospital	Ph:  847-570-1381
	Urbana
	CCOP - Carle Cancer Center
		Clinical Trials Office - CCOP - Carle Cancer Center	Ph:  800-446-5532
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
	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
	Grand Rapids
	CCOP - Grand Rapids
		Marianne Lange, MD	Ph:  616-977-6243
	Kalamazoo
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
	Royal Oak
	William Beaumont Hospital - Royal Oak Campus
		Clinical Trials Office - William Beaumont Hospital - Royal Oak Campus	Ph:  248-551-7695
Minnesota
	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
	Springfield
	St. John's Regional Health Center
		John Goodwin, MD	Ph:  417-269-4520
Nevada
	Las Vegas
	Women's Cancer Center - Lake Mead
		Nick Spirtos, MD	Ph:  408-866-3843
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
North Carolina
	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
		Clinical Trials Office - OSU Comprehensive Cancer Center	Ph:  614-293-4976
			Email: osu@emergingmed.com
	Mount Carmel Health - West Hospital
		George Lewandowski, MD	Ph:  614-224-7662
	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
Oregon
	Portland
	Oregon Health and Science University Cancer Institute
		Clinical Trials Office - Oregon Health and Science University Cancer Institute	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
		Paul Gilman, MD	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
	MBCCOP - Meharry Medical College - Nashville
		Steven Wolff, MD	Ph:  615-327-6277
Texas
	Amarillo
	Harrington Cancer Center
		Clinical Trials Officec - Harrington Cancer Center	Ph:  806-359-4673
			Email: ryokubaitis@harringtoncc.org
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
		Dennis Scribner, MD	Ph:  540-345-8574
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		2009-01-15
NCI Grant/Contract Number		CA101165