Trials / Completed
CompletedNCT00375427
Safety and Efficacy of Zoledronic Acid in Patients With Breast Cancer With Metastatic Bone Lesions
A Prospective, Randomized, Multi-center Comparative 2-arm Trial of Efficacy and Safety of Zoledronic Acid (Every 3-months vs. Every 4 Weeks) Beyond Approximately 1 Year of Treatment With Zoledronic Acid in Patients With Bone Lesions From Breast Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 430 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the clinical benefit of two different dosing schedules of zoledronic acid in patients with metastatic bone lesions from breast cancer who have already been treated with zoledronic acid for about one year.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zoledronic acid | Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. |
Timeline
- Start date
- 2006-02-01
- Primary completion
- 2010-02-01
- First posted
- 2006-09-13
- Last updated
- 2012-04-11
- Results posted
- 2011-08-04
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT00375427. Inclusion in this directory is not an endorsement.