A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss
Breast cancer and osteoporosis are two of the most frequent diseases in women. Estrogen may be associated with bone loss and the risk of breast cancer because of its potent effects on the mitotic activity of breast epithelium and on bone turnover.
This study is will assess the safety and efficacy of Zoledronic acid 4 mg, given every 3 months over 24 months, in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment compared to placebo.
This study is not recruiting patients in the United States.
Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women
Drug: Zoledronic Acid
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Influence of Zoledronic Acid on Bone Mineral Density and Bone Ultrasonometry in Premenopausal Women With Hormone Receptor Negative Breast Cancer and Adjuvant Chemotherapeutic Treatment|
- Change in Bone Mineral Density (BMD) Measured by DXA at Lumbar Spine (L2-L4) Between Baseline and 24 Months. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Bone Mineral Density (BMD) Measured by QUS at os Calcis and Phalanges After 24 Months [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Course of Biochemical Markers of Bone Turn Over (FSH, Estradiol (E2), Osteocalcin, PINP, Procollagene-I-peptid, Deoxypyridinoline in Serum) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Pathologic Fractures During 24 Month [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Development of Metastases as Assessed by X-ray, CT, or MRI During 24 Months and During 60 Months [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Zoledronic Acid
Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
Drug: Zoledronic Acid
4 mg zoledronic acid in 5 mL concentrate solution. Plastic vials.
Placebo Comparator: Placebo
Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333229
|Novartis Investigative Site|
|Marburg, Germany, 35043|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmeceuticals|