CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Zoledronic aciddrug
Likely dose
Zoledronic acid 4mgfrom 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/NCT00577642
NCT00577642Phase 2Completed

A Phase II Study of Bone Marker Assessment of Multiple Myeloma Patients Treated With AminoBisphosphonates

Massachusetts General Hospital·interventional·Posted Dec 20, 2007·Updated Mar 10, 2017

In Brief

A Phase 2 clinical trial evaluating Zoledronic acid for Multiple Myeloma. Completed, enrolled 29 participants across 1 site.

Detailed Summary

The purpose of this research study is to define the time a molecule in the participants bones called NTX begins to rise after receiving treatment with bisphosphonates. NTX is measured in the urine to determine the rate of bone breakdown. Tracking this marker may help identify a more optimal dosing schedule of bisphosphonate therapy. Bisphosphonate drugs like zoledronic acid, which will be used in this study, are used to reduce pain and bone fractures in people with multiple myeloma. There is some laboratory data to suggest that they may work against myeloma. Participants will have already undergone bisphosphonate therapy and may have received zoledronic acid as treatment. Typically these agents are continued indefinitely. Due to concerns of their long-term side effects we are looking at alternate strategies for reducing the frequency of these agents.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 20, 2007
Enrollment StartOct 1, 2007
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 18.5 years ago

Interventions

Zoledronic aciddrug

4mg IV over at least 15 minutes or corrected for creatinine clearance x 1