Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00712985 | Single Dosing of Zoledronic Acid in Cancer Therapy Induced Bone Loss (CTIBL) | PHASE3 | COMPLETED | 18 | — | — | Sep 1, 2005 | Mar 1, 2011 | Apr 24, 2014 | 1 | United States |
17 women with early breast cancer receiving adjuvant Aromatase Inhibitor (AI) therapy were treated with a single 5 mg IV dose of zoledronic acid. Urine and serum NTx and serum CTx were measured at baseline and month 12.
| Arm | Type | Description |
|---|---|---|
| Zometa (Zoledronic Acid) X 1 dose | EXPERIMENTAL | Zometa (Zoledronic Acid) 5 mg IV X 1 dose |
| Name | Type | Description |
|---|---|---|
| Zometa | DRUG | Zometa (Zoledronic Acid) 5 mg IV over 15 minutes in a one time dose |
Inclusion Criteria: * Postmenopausal women with Stage I, II or IIIa breast cancer being treated with a non-steroidal Aromatase Inhibitor (AI) .Negative bone scan (no bone metastases). * Calculated creatinine clearance \> 40 ml/min * Documented T score of less than or equal to -1.5 on Dual Energy X-...