CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 135 enrolled
Drug / intervention
Zoledronic Acid +2 moredrug
Likely dose
Zoledronic Acid 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00352846
NCT00352846Phase 3Completed
CompareCT.gov

Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss in Non-Hodgkin's Lymphoma Patients Receiving Chemotherapy

M.D. Anderson Cancer Center·interventional·Posted Jul 17, 2006·Updated Jul 2, 2013

In Brief

A Phase 3 clinical trial evaluating Zoledronic Acid, Vitamin D, and 1 other intervention for Non-Hodgkin's Lymphoma and Lymphoma. Completed, enrolled 135 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma, Lymphoma
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 17, 2006
Enrollment StartJan 1, 2006
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 20.0 years ago

Interventions

Zoledronic Aciddrug

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

Vitamin Ddrug

400 mg by mouth daily

Calcium Carbonatedrug

1200 mg by mouth daily