Status:
COMPLETED
Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Osteoporosis
Eligibility:
FEMALE
18-120 years
Phase:
NA
Brief Summary
RATIONALE: Zoledronate may reduce bone loss in patients receiving letrozole for breast cancer. PURPOSE: This clinical trial is studying how well zoledronate works in treating osteopenia or osteoporos...
Detailed Description
OBJECTIVES: Primary * Assess changes in total lumbar spine bone mineral density (BMD) from baseline to 12 months in postmenopausal women treated with zoledronate for osteopenia or osteoporosis and l...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of localized breast cancer
- Stage I-IIIA disease
- Adequately treated breast cancer
- No clinical or radiological evidence of recurrent or metastatic disease
- Baseline total lumbar spine or femoral neck bone mineral density T-score \< -2.0 standard deviation (e.g., a patient with a T score of -2.1 is eligible)
- Hormone-receptor status:
- Estrogen receptor and/or progesterone receptor-positive breast cancer
- PATIENT CHARACTERISTICS:
- Female
- Postmenopausal, defined by 1 of the following criteria:
- Age \> 55 years with cessation of menses
- Age ≤ 55 years with spontaneous cessation of menses for \> 1 year
- Age ≤ 55 years with spontaneous cessation of menses for ≤ 1 year, but amenorrheic (e.g., spontaneous or secondary to hysterectomy), AND has postmenopausal estradiol levels
- Bilateral oophorectomy
- ECOG performance status 0-2
- Life expectancy ≥ 5 years
- WBC ≥ 3,000/mm³ OR granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
- AST ≤ 3 times ULN
- Creatinine \< 2.0 mg/dL
- Creatinine clearance ≥ 45 mL/min
- No hypercalcemia (i.e., calcium level \> 1 mg/dL above ULN) OR hypocalcemia (i.e., calcium level \> 0.5 mg/dL below lower limit of normal) within the past 6 months
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No other nonmalignant systemic diseases, including any of the following:
- Uncontrolled infection
- Uncontrolled diabetes mellitus
- Uncontrolled thyroid dysfunction
- Disease affecting bone metabolism (hyperparathyroidism, hypercortisolism, Paget's disease, osteogenesis imperfecta)
- Malabsorption syndrome
- No uncontrolled seizure disorders associated with falls
- No known hypersensitivity to zoledronate or other bisphosphonates, letrozole, calcium, or vitamin D
- No concurrent active dental problems, including any of the following:
- Infection of the teeth or jawbone (maxillary or mandibular)
- Dental or fixture trauma
- Prior or current diagnosis of osteonecrosis of the jaw
- Exposed bone in the mouth
- Slow healing after dental procedures
- No contraindication to spine dual energy x-ray absorptiometry (DXA) as defined by any of the following:
- History of surgery at the lumbosacral spine, with or without implantable devices
- Scoliosis with a Cobb angle \> 15 degrees at the lumbar spine
- Immobility, hyperostosis, or sclerotic changes at the lumbar spine, or evidence of sclerotic abdominal aorta sufficient to interfere with DXA scan
- Disease of the spine that would preclude the proper acquisition of a lumbar spine DXA
- No condition that would preclude study follow-up or compliance
- No psychiatric illness that would preclude giving informed consent
- PRIOR CONCURRENT THERAPY:
- More than 3 weeks since prior and no other concurrent oral bisphosphonates
- No prior intravenous bisphosphonates
- No prior aromatase inhibitor therapy
- More than 6 months since prior anabolic steroids or growth hormone
- More than 2 weeks since prior and no concurrent inhibitor of osteoclastic bone resorption (e.g., calcitonin, mithramycin, or gallium nitrate)
- More than 30 days since prior systemic investigational drug and/or device
- More than 7 days since prior topical investigational drug
- More than 6 weeks since prior and no concurrent dental or jaw surgery (e.g., extraction, implants)
- Concurrent short-term corticosteroid therapy allowed
- No concurrent sodium fluoride, parathyroid hormone, or tibolone
- No other concurrent investigational drug or device
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00436917
Start Date
April 1 2006
End Date
May 9 2016
Last Update
September 11 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
2
Mayo Clinic
Rochester, Minnesota, United States, 55905