Phase 3
Completed N=1,065
Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.
Source: ClinicalTrials.gov NCT00171340 ↗Enrolled (actual)
1,065
Serious AEs
24.3%
Results posted
May 2011
Primary outcomePrimary: Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy. — 2.208; -3.617 Percentage change in BMD
Summary
Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy. |
2.208; -3.617 | — |
| SECONDARY Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy. |
3.463; -4.601; 3.730; -4.871; 3.782; -5.154 | — |
| SECONDARY Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy. |
2.128; -3603; 3.300; -4.521; 3.521; -4.869 | — |
| SECONDARY Percentage Change in Bone Mineral Density (BMD) of the Total Hip at 12 Months, 2 Years, 3 Years, 4 Years and 5 Years After Therapy. |
1.222; -2.239; 1.649; -2.990; 1.754; -3.302 | — |
| SECONDARY Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline |
0.6; 1.5 | — |
Eligibility Criteria
Inclusion Criteria
- Stage I-IIIa breast cancer
- Postmenopausal or recently postmenopausal
- Recent surgery for breast cancer
- Estrogen Receptor positive and/or progesterone receptor positive hormone receptor status
- No prior treatment with letrozole
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Metastatic disease
- Invasive bilateral disease
- Clinical or radiological evidence of existing fracture in spine or hip
- Prior treatment with IV bisphosphonates in the past 12 months
- Current treatment with oral bisphosphonates ( must be discontinued within 3 weeks of baseline evaluation)
- Use of Tibolone within 6 months
- Prior use of parathyroid hormone for more than 1 week
- Previous or concomitant malignancy
- Abnormal renal function
- History of disease effecting bone metabolism
Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00171340). 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. Informational only — not medical advice.