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NCT00050011 · ClinicalTrials.gov registry record · Phase 3
Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 602
- Enrollment target
NCT00050011 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 602 participants.
The verdict
NCT00050011, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 602 participants
- Enrollment target
Study Summary
This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6 months when given upfront versus delayed start (based on a post-baseline BMD T- Score below -2.0 SD at either the lumbar spine or total hip, or any clinical fracture unrelated to trauma, or an asymptomatic fracture discovered at the month 36 scheduled visit) in stage I-IIIb postmenopausal women with hormone receptor positive breast cancer who will receive Letrozole 2.5 mg daily as an adjuvant therapy.
Interventions
- DRUG Letrozole
- DRUG Zoledronic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 602 participants |
| Start Date | 2002-09 |
| Est. Completion | 2009-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00050011
The ClinicalTrials.gov registry entry for NCT00050011 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 602 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Letrozole is the first listed.
NCT00050011 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00050011 about?
NCT00050011 is a clinical study titled "Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy". This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6 months when given upfront versus delayed start (based on a post-baseline BMD T- Score below -2.0 SD at either the lumbar spine or total hip, or any clinical fracture unrelated to trauma, or an asymptomatic fractu...
What is the current status of trial NCT00050011?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 602 participants. The study started on 2002-09. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00050011?
The interventions under investigation include: Letrozole (DRUG), Zoledronic Acid (DRUG).
Who is sponsoring clinical trial NCT00050011?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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