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Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer

NCT00054418 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2016-07-13

No results posted yet for this study

Summary

RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without risedronate in preventing bone loss.

PURPOSE: This randomized phase III trial is studying two forms of calcium with or without risedronate to compare how well they work in preventing bone loss in premenopausal women who are receiving chemotherapy for primary stage I, stage II, stage IIIA, or stage IIIB breast cancer.

Conditions

Interventions

DIETARY_SUPPLEMENT

calcium carbonate

calcium 600 mg daily administered orally for one year

DIETARY_SUPPLEMENT

vitamin D

vitamin D 400 U daily administered orally for one year

DRUG

risedronate sodium

risedronate 35 mg weekly administered orally

OTHER

placebo

placebo tablet weekly administered orally for one year

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Stephanie Hines, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2007-04-30
Completion
2008-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00054418 on ClinicalTrials.gov