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Hereditary Breast and Ovarian Cancer SyndromePhase 2NCT00305695

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

A Phase 2 study testing Laboratory Biomarker Analysis and Zoledronic Acid in people with Hereditary Breast and Ovarian Cancer Syndrome and Osteoporosis, run by Gynecologic Oncology Group at 95 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age, women only
What is being tested?
Laboratory Biomarker Analysis and Zoledronic Acid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
95 sitesUnited States
Study dates
28 Nov 2005to 22 Dec 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 59Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

95 sites in 1 country.

95 sites in 1 country

United States95 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • Colorado Gynecologic Oncology Group

    Aurora, Colorado, 80010

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Chattanooga's Program in Women's Oncology

    Chattanooga, Tennessee, 37403

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Cincinnati/Barrett Cancer Center

    Cincinnati, Ohio, 45219

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • SCL Health Saint Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Saint Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Truman Medical Center

    Kansas City, Missouri, 64108

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Heartland Hematology and Oncology Associates Incorporated

    Kansas City, Missouri, 64118

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Norton Hospital Pavilion and Medical Campus

    Louisville, Kentucky, 40202

  • McKee Medical Center

    Loveland, Colorado, 80539

  • North Shore University Hospital

    Manhasset, New York, 11030

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Virtua Memorial

    Mount Holly, New Jersey, 08060

  • Meharry Medical College

    Nashville, Tennessee, 37208

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Yale University

    New Haven, Connecticut, 06520

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Mount Sinai Hospital

    New York, New York, 10029

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • UF Cancer Center at Orlando Health

    Orlando, Florida, 32806

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's South Hospital

    Overland Park, Kansas, 66213

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Center of Hope at Renown Medical Center

    Reno, Nevada, 89502

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • Carilion Clinic Gynecological Oncology

    Roanoke, Virginia, 24016

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64507

  • University of California San Diego

    San Diego, California, 92103

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Saint Louis-Cape Girardeau CCOP

    St Louis, Missouri, 63141

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • SCL Health Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Northwestern Medicine Central DuPage Hospital

    Winfield, Illinois, 60190

  • Main Line Health NCORP

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  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 OBJECTIVE:

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

TERTIARY OBJECTIVE:

  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.

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.

Being tested
Laboratory Biomarker Analysis, Zoledronic Acid
Medical subject headings
Hereditary Breast and Ovarian Cancer Syndrome, Osteoporosis, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Zoledronic AcidDrug

    Also called [1-Hydroxy-2-(1H-imidazol-1-yl)ethylidene]bisphosphonic Acid, CGP 42446, CGP42446A, NDC-Zoledronate

    Given IV

Study groups in NCT00305695
Study groupRoleWhat they receive
Arm I (zoledroic acid)ExperimentalBeginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
Receives: Other: Laboratory Biomarker Analysis; Drug: Zoledronic Acid
Arm II (clinical observation)No interventionPatients are observed for 18 months after surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 9 Months

  2. 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).

    Measured: 18 months

  3. 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

    Measured: 18 months

  4. 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

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2006 (estimated)
  2. Study start28 Nov 2005
  3. Primary completion22 Dec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00305695
Sponsor's protocol ID
GOG-0215
Other IDs
NCI-2009-00589, NCI-P6966, NOVARTIS-GOG-0215, CDR0000462217, NCI-06-C-0204, GOG-0215, GOG-0215, GOG-0215
Status last verified
Mar 2020
First submitted
21 Mar 2006
Last updated
24 Mar 2020

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laboratory Biomarker Analysis and Zoledronic Acid in people with Hereditary Breast and Ovarian Cancer Syndrome and Osteoporosis, run by Gynecologic Oncology Group at 95 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 59 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 9 Months (time frame: 9 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00305695.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.

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