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COMPLETED Phase 3

Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer

NCT00022087 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Zoledronate plus calcium and vitamin D may prevent bone loss in patients receiving adjuvant chemotherapy for breast cancer. It is not yet known which regimen is more effective in preventing bone loss. PURPOSE: This randomized phase III trial is comparing two regimens of zoledronate plus calcium and vitamin D to see how well they work in preventing bone loss in women who are receiving adjuvant chemotherapy for breast cancer.

Interventions

  • DRUG zoledronic acid
  • DIETARY_SUPPLEMENT cholecalciferol
  • DIETARY_SUPPLEMENT calcium salts

Study Locations (20)

Florida

  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital — Fort Lauderdale
  • Memorial Cancer Institute at Memorial Regional Hospital — Hollywood
  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center — Jupiter
  • CCOP - Mount Sinai Medical Center — Miami Beach
  • Cancer Research Network, Incorporated — Plantation
  • Cleveland Clinic Florida - Weston — Weston

California

  • Arroyo Grande Community Hospital — Arroyo Grande
  • Rebecca and John Moores UCSD Cancer Center — La Jolla
  • El Camino Hospital — Mountain View
  • Naval Medical Center - San Diego — San Diego
  • Veterans Affairs Medical Center - San Diego — San Diego

Delaware

  • Kent General Hospital at Bayhealth Medical Center — Dover
  • Beebe Medical Center — Lewes
  • CCOP - Christiana Care Health Services — Newark
  • St. Francis Hospital — Wilmington

District of Columbia

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center — Washington D.C.
  • Washington Cancer Institute at Washington Hospital Center — Washington D.C.
  • Sibley Memorial Hospital — Washington D.C.

Illinois

  • St. Joseph Medical Center — Bloomington
  • Graham Hospital — Canton

Trial Details

FieldValue
Enrollment Target 439 participants
Start Date 2001-12
Est. Completion 2009-02
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00022087

The ClinicalTrials.gov registry entry for NCT00022087 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 439 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which zoledronic acid is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00022087 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Delaware. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00022087 about?

NCT00022087 is a clinical study titled "Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer". RATIONALE: Zoledronate plus calcium and vitamin D may prevent bone loss in patients receiving adjuvant chemotherapy for breast cancer. It is not yet known which regimen is more effective in preventing bone loss. PURPOSE: This randomized phase III trial is comparing two regimens of zoledronate plus ...

What is the current status of trial NCT00022087?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 439 participants. The study started on 2001-12. Estimated completion is 2009-02.

What conditions does trial NCT00022087 study?

This clinical trial studies the following conditions: Breast Cancer, Osteoporosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00022087?

The interventions under investigation include: zoledronic acid (DRUG), cholecalciferol (DIETARY_SUPPLEMENT), calcium salts (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00022087?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00022087 being conducted?

This trial has 20 study locations across California, Delaware, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial