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

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ClinicalTrials.gov Identifier: NCT00305695
Recruitment Status : Completed
First Posted : March 22, 2006
Results First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Brief 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.

Condition or disease Intervention/treatment Phase
Hereditary Breast and Ovarian Cancer Syndrome Osteoporosis Ovarian Carcinoma Other: Laboratory Biomarker Analysis Drug: Zoledronic Acid Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : November 28, 2005
Actual Primary Completion Date : December 22, 2011


Arm Intervention/treatment
Experimental: Arm I (zoledroic acid)
Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.
Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Zoledronic Acid
Given IV
Other Names:
  • [1-Hydroxy-2-(1H-imidazol-1-yl)ethylidene]bisphosphonic Acid
  • CGP 42446
  • CGP42446A
  • NDC-Zoledronate
  • Reclast
  • ZOL 446
  • Zometa

No Intervention: Arm II (clinical observation)
Patients are observed for 18 months after surgery.



Primary Outcome Measures :
  1. Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 9 Months [ Time Frame: 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).

  2. Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 18 Months [ Time Frame: 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).

  3. Bone Mineral Density of the Total Hip as Measured by DEXA Scan on Right Hip [ Time Frame: 18 months ]
    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

  4. Bone Mineral Density of the Total Hip as Measured by DEXA Scan on Left Hip [ Time Frame: 18 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305695


Locations
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Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: David S Alberts Gynecologic Oncology Group
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Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00305695    
Other Study ID Numbers: GOG-0215
NCI-2009-00589 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI-P6966
NOVARTIS-GOG-0215
CDR0000462217
NCI-06-C-0204
GOG-0215 ( Other Identifier: Gynecologic Oncology Group )
GOG-0215 ( Other Identifier: DCP )
GOG-0215 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
First Posted: March 22, 2006    Key Record Dates
Results First Posted: March 24, 2020
Last Update Posted: March 24, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Hereditary Breast and Ovarian Cancer Syndrome
Osteoporosis
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Breast Neoplasms
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Breast Diseases
Skin Diseases
Zoledronic Acid
Imidazole
Bone Density Conservation Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action