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Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss

NCT00352846 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2013-07-02

Study results available
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Summary

Primary Objective:

* Evaluate the effect of zoledronate on change in bone mineral density (BMD) at the total lumbar spine and femoral neck.

Secondary Objectives:

* Evaluate the effect of zoledronate on change in BMD at the total hip
* Evaluate risk factors for developing osteoporosis on chemotherapy
* Determine correlative markers for response to zoledronate 4. Evaluate zoledronate effect on new bone fractures 5. Evaluate the cost-effectiveness of zoledronic acid (with calcium and vitamin D) versus standard treatment (calcium and vitamin D alone).

Conditions

Interventions

DRUG

Zoledronic Acid

4 mg/m\^2 by vein over 30 Minutes at baseline and 6 months.

DRUG

Vitamin D

400 mg by mouth daily

DRUG

Calcium Carbonate

1200 mg by mouth daily

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Fredrick Hagemeister, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00352846 on ClinicalTrials.gov