Phase 2
N=68
Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00213980 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Change in Bone Mineral Density (BMD) From Baseline to 1 Year — 0.048; 0.007; 0.014; 0.005 grams per cubic centimeter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Zoledronate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bone Mineral Density (BMD) From Baseline to 1 Year |
0.048; 0.007; 0.014; 0.005; 0.019; 0.004 | — |
| SECONDARY Rates of Metastases |
— | — |
| SECONDARY Overall Survival |
24; 22 | — |
| SECONDARY Clinical Toxicity of ZA |
36; 23 | — |
Summary
This is a two arm, double-blind randomized study looking at the effect of zoledronate, a bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer.
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women, Stage III or axillary node positive
- Currently disease free of breast cancer and other invasive malignancies at the time of registration
- No concurrent use of bisphosphonates
Exclusion Criteria
- Metastatic disease
Data sourced from ClinicalTrials.gov (NCT00213980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.