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



Status:Active, not recruiting
Conditions:Breast Cancer, Ovarian Cancer, Cancer, Osteoporosis
Therapuetic Areas:Oncology, Rheumatology
Healthy:No
Age Range:Any
Updated:3/14/2019
Start Date:November 28, 2005

Use our guide to learn which trials are right for you!

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

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.

PRIMARY OBJECTIVE:

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.

SECONDARY OBJECTIVE:

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

TERTIARY OBJECTIVE:

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.

Inclusion Criteria:

- 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:

- 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

- 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
We found this trial at
95
sites
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
?
mi
from
Duarte, CA
Click here to add this to my saved trials
4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Jupiter, Florida 33458
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
?
mi
from
Richmond, VA
Click here to add this to my saved trials
3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
Aurora, Colorado 80010
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
?
mi
from
Boulder, CO
Click here to add this to my saved trials
?
mi
from
Burbank, CA
Click here to add this to my saved trials
Burlington, North Carolina 27216
?
mi
from
Burlington, NC
Click here to add this to my saved trials
Burlington, Vermont 05405
?
mi
from
Burlington, VT
Click here to add this to my saved trials
?
mi
from
Camden, NJ
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chattanooga, Tennessee 37403
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Univ of Illinois A major research university in the heart of one of the world's...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45220
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
6001 E Woodmen Rd
Colorado Springs, Colorado 80923
(719) 776-5000
Penrose-Saint Francis Healthcare Founded by the Sisters of St. Francis and the Sisters of Charity,...
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43222
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Denver, Colorado 80218
?
mi
from
Denver, CO
Click here to add this to my saved trials
4567 E 9th Ave
Denver, Colorado 80220
(303) 320-2121
Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for...
?
mi
from
Denver, CO
Click here to add this to my saved trials
Elkton, Maryland 21921
?
mi
from
Elkton, MD
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
1801 16th St
Greeley, Colorado 80631
(970) 352-4121
North Colorado Medical Center NCMC is a fully accredited, private, non-profit facility licensed to operate...
?
mi
from
Greeley, CO
Click here to add this to my saved trials
835 S Van Buren St
Green Bay, Wisconsin 54301
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
?
mi
from
Hartford, CT
Click here to add this to my saved trials
1 Jarrett White Rd
Honolulu, Hawaii 96859
(808) 433-6661
Tripler Army Medical Center The attack of Pearl Harbor led to the construction of Tripler...
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
2301 Holmes
Kansas City, Missouri 64108
816-404-1000
Truman Medical Center Located in the heart of downtown Kansas City, TMC Hospital Hill is...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
2800 Clay Edwards Dr
Kansas City, Missouri 64116
(816) 691-2000
North Kansas City Hospital Generations of Northlanders have considered North Kansas City Hospital as their...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
5400 N Oak Trafficway, Suite 101
Kansas City, Missouri 64118
(855) 603-3282
Heartland Hematology Oncology Associates, Incorporated Heartland Hematology-Oncology Associates PA in Kansas, Missouri, is a private...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
450 Lakeville Road
Lake Success, New York 11042
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
Las Vegas, Nevada 89109
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
100 NE St Lukes Blvd
Lee's Summit, Missouri 64086
(816) 347-5000
Saint Luke's East - Lee's Summit Founded in 2006, Saint Luke
?
mi
from
Lee's Summit, MO
Click here to add this to my saved trials
424 Savannah Rd
Lewes, Delaware 19958
(302) 645-3300
Beebe Medical Center Located in beautiful historic Lewes, Delaware, near Rehoboth Beach, Beebe Healthcare offers...
?
mi
from
Lewes, DE
Click here to add this to my saved trials
Lexington, Kentucky 40503
?
mi
from
Lexington, KY
Click here to add this to my saved trials
4733 Sunset Blvd
Los Angeles, California 90027
(800) 954-8000
Kaiser Permanente Los Angeles Medical Center We've been there for you in the past, providing...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
2000 N Boise Ave
Loveland, Colorado 80538
(970) 669-4640
McKee Medical Center Through the years, McKee has led the way in health care innovation....
?
mi
from
Loveland, CO
Click here to add this to my saved trials
?
mi
from
Mentor, OH
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Mount Holly, New Jersey 08060
?
mi
from
Mount Holly, NJ
Click here to add this to my saved trials
Nashville, Tennessee 37208
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Nashville, Tennessee 37232
?
mi
from
Nashville, TN
Click here to add this to my saved trials
100 Grand St
New Britain, Connecticut 06050
(860) 224-5011
The Hospital of Central Connecticut The Hospital of Central Connecticut is dedicated to fostering, sustaining...
?
mi
from
New Britain, CT
Click here to add this to my saved trials
New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
270-05 76th Ave
New Hyde Park, New York 11040
(718) 470-7480
Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
?
mi
from
New Hyde Park, NY
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
4755 Ogletown-Stanton Road
Newark, Delaware 19718
302-733-1000
Christiana Care Health System - Christiana Hospital A 913-bed, 1.3-million-square-foot, modern facility in Newark, Delaware,...
?
mi
from
Newark, DE
Click here to add this to my saved trials
940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
5721 W 119th St
Overland Park, Kansas 66209
(913) 498-6000
Menorah Medical Center Menorah Medical Center (MMC), a full-service, acute care hospital located on the...
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
12300 Metcalf Ave
Overland Park, Kansas 66213
(913) 317-7000
Saint Luke's South Hospital Saint Luke's South Hospital is a comprehensive health care facility serving...
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
875 Blake Wilbur Drive
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
?
mi
from
Pinehurst, NC
Click here to add this to my saved trials
Providence, Rhode Island 02905
?
mi
from
Providence, RI
Click here to add this to my saved trials
?
mi
from
Reno, NV
Click here to add this to my saved trials
Roanoke, Virginia 24016
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
3601 W 13 Mile Rd
Royal Oak, Michigan 48073
(248) 898-5000
William Beaumont Hospital-Royal Oak The largest Beaumont Hospital is located at 3601 W Thirteen Mile...
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
3333 W Deyoung St
Saint Joseph, Missouri 64506
(618) 998-7000
Heartland Regional Medical Center Heartland Regional Medical Center is your community healthcare provider; a 98-bed...
?
mi
from
Saint Joseph, MO
Click here to add this to my saved trials
Saint Louis, Missouri 63141
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Louis, Missouri 63141
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Diego, California 92093
?
mi
from
San Diego, CA
Click here to add this to my saved trials
13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
615 N Michigan St
South Bend, Indiana 46601
(574) 647-1000
Memorial Hospital of South Bend Memorial Hospital of South Bend is a community-owned, not-for-profit corporation...
?
mi
from
South Bend, IN
Click here to add this to my saved trials
1235 E Cherokee St
Springfield, Missouri 65804
(417) 820-2000
Mercy Hospital Springfield We're continuing a tradition of healing more than 120 years old. Mercy...
?
mi
from
Springfield, MO
Click here to add this to my saved trials
3801 South National Avenue
Springfield, Missouri 65807
(417) 269-6000
CoxHealth South Hospital U.S. News & World Report has ranked CoxHealth one of Missouri's best...
?
mi
from
Springfield, MO
Click here to add this to my saved trials
9191 Grant St
Thornton, Colorado 80229
(303) 451-7800
North Suburban Medical Center North Suburban Medical Center has established a reputation as a facility...
?
mi
from
Thornton, CO
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
602 W University Ave
Urbana, Illinois 61801
(217) 383-3010
Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
?
mi
from
Urbana, IL
Click here to add this to my saved trials
Washington, District of Columbia
?
mi
from
Washington,
Click here to add this to my saved trials
West Allis, Wisconsin 53227
?
mi
from
West Allis, WI
Click here to add this to my saved trials
Wheat Ridge, Colorado 80033
?
mi
from
Wheat Ridge, CO
Click here to add this to my saved trials
?
mi
from
Winfield, IL
Click here to add this to my saved trials
Wynnewood, Pennsylvania 19096
?
mi
from
Wynnewood, PA
Click here to add this to my saved trials