Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer
|ClinicalTrials.gov Identifier: NCT00436917|
Recruitment Status : Completed
First Posted : February 19, 2007
Results First Posted : August 12, 2011
Last Update Posted : April 18, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Osteoporosis||Drug: zoledronic acid Procedure: Letrozole as adjuvant therapy||Not Applicable|
- 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 letrozole for hormone receptor-positive, stage I-IIIA primary breast cancer.
- Determine changes in total lumbar spine BMD from baseline to 2, 3, 4, and 5 years in these patients.
- Determine changes in femoral neck BMD from baseline to 1, 2, 3, 4, and 5 years in these patients.
- Determine time to disease progression in these patients.
OUTLINE: This is an open-label, multicenter study.
- Adjuvant aromatase inhibitor therapy: Patients receive oral letrozole daily for up to 5 years in the absence of disease progression or unacceptable toxicity.
- Osteoporosis management: Patients receive zoledronate IV over 15 minutes on day 1. Patients also receive oral elemental calcium twice daily and oral vitamin D daily for 6 months. Treatment repeats every 6 months for up to 5 years in the absence of disease progression or unacceptable toxicity.
Patients undergo total lumbar spine and hip (femoral neck) bone density testing by dual energy x-ray absorptiometry (DXA) at baseline and annually for 5 years.
After completion of study therapy, patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Zoledronic Acid for Treatment of Osteopenia and Osteoporosis in Women With Primary Breast Cancer Undergoing Adjuvant Aromatase Inhibitor (Letrozole) Therapy|
|Actual Study Start Date :||April 2006|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||May 9, 2016|
Experimental: zoledronic acid
4 mg 15 minutes IV infusion. If creatinine clearance is ≤ 60, dosage should be adjusted as follows:CrCl 50-60: 3.5 mg; CrCl 40-49: 3.3 mg; CrCl 30-39: 3.0 mg.
Drug: zoledronic acid
Other Name: Zometa®Procedure: Letrozole as adjuvant therapy
Other Name: Femara®
- Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) [ Time Frame: Baseline and 1 year ]Change: BMD values at twelve months post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
- Total Lumbar Spine BMD as Measured by DXA at Baseline and at 24, 36, 48, and 60 > Months [ Time Frame: 5 yr ]
- Femoral Neck BMD as Measured by DXA at Baseline and at 12, 24, 36, 48, and 60 Months [ Time Frame: 5 yr ]
- Frequency and Severity of Toxicity as Assessed by NCI CTCAE v3.0 [ Time Frame: 5 yr ]
- Time to Disease Progression [ Time Frame: 5 yr ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436917
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Stephanie Hines, MD||Mayo Clinic|
|Principal Investigator:||Charles L. Loprinzi, MD||Mayo Clinic|