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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


Phase 2
N/A
N/A
Open (Enrolling)
Female
Hereditary Breast/Ovarian Cancer (brca1, brca2), Osteoporosis, Ovarian Cancer

Thank you

Trial Information

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


OBJECTIVES:

Primary

- 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

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

Tertiary

- 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.

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

Inclusion 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

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

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

David S. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona

Authority:

United States: Federal Government

Study ID:

CDR0000462217

NCT ID:

NCT00305695

Start Date:

November 2005

Completion Date:

Related Keywords:

  • Hereditary Breast/Ovarian Cancer (brca1, brca2)
  • Osteoporosis
  • Ovarian Cancer
  • osteoporosis
  • hereditary breast/ovarian cancer (BRCA1, BRCA2)
  • ovarian epithelial cancer
  • Osteoporosis
  • Ovarian Neoplasms

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
CCOP - Colorado Cancer Research ProgramDenver, Colorado  80224-2522
St. Joseph HospitalDenver, Colorado  80218
North Suburban Medical CenterThornton, Colorado  80229
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Avera Cancer InstituteSioux Falls, South Dakota  57105
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Washington Cancer Institute at Washington Hospital CenterWashington, District of Columbia  20010
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Carilion Gynecologic Oncology AssociatesRoanoke, Virginia  24014
Central Baptist HospitalLexington, Kentucky  40503
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Yale Cancer CenterNew Haven, Connecticut  06520-8028
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Mount Sinai Medical CenterNew York, New York  10029
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital CenterBaltimore, Maryland  21237
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Stanford Cancer CenterStanford, California  94305-5824
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Evanston HospitalEvanston, Illinois  60201-1781
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Truman Medical Center - Hospital HillKansas City, Missouri  64108
Heartland Hematology Oncology Associates, IncorporatedKansas City, Missouri  64118
Monter Cancer Center of the North Shore-LIJ Health SystemLake Success, New York  11042
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
FirstHealth Moore Regional Community Hospital Comprehensive Cancer CenterPinehurst, North Carolina  28374
Louisville Oncology at Norton Cancer Institute - LouisvilleLouisville, Kentucky  40202
Good Samaritan Hospital Cancer Treatment CenterCincinnati, Ohio  45220
Renown Institute for Cancer at Renown Regional Medical CenterReno, Nevada  89502
Central Dupage Cancer CenterWarrenville, Illinois  60555
Arizona Cancer Center at University Medical Center NorthTucson, Arizona  85719