Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole fo… (NCT00436917) | Clinical Trial Compass
CompletedNot Applicable
Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer
United States60 participantsStarted 2006-04
Plain-language 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 osteoporosis in postmenopausal women receiving letrozole for stage I, stage II, or stage IIIA primary breast cancer.
Who can participate
Age range18 Years – 120 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 syst…
What they're measuring
1
Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD)