CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 81 enrolled
Drug / intervention
Reclast (ZOL446, zoledronic acid) +2 moredrug
Likely dose
Reclast (ZOL446, zoledronic acid) 5 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/NCT00668200
NCT00668200Phase 4Completed
CompareCT.gov

Post US Approval Voluntary Registry Study to Determine Incidence of Hypocalcemia Post Reclast® Treatment in Patients With Paget's Disease After Institution of Educational Strategies to Improve Adherence to Calcium and Vitamin D Supplementation

Novartis Pharmaceuticals·interventional·Posted Apr 29, 2008·Updated Mar 6, 2015

In Brief

A Phase 4 clinical trial evaluating Reclast (ZOL446, zoledronic acid), Calcium, and 1 other intervention for Paget's Disease of the Bone and Hypocalcemia. Completed, enrolled 81 participants across 9 sites.

Detailed Summary

This study will evaluate the impact of investigator and patient education and educational materials to foster calcium and vitamin D supplementation to mitigate the potential for hypocalcemia post Reclast® administration in patients with Paget's disease of bone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPaget's Disease of the Bone, Hypocalcemia
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 29, 2008
Enrollment StartMay 1, 2008
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 18.2 years ago

Interventions

Reclast (ZOL446, zoledronic acid)drug

5 mg i.v. annually ("real-life, physician prescribed")

Calciumdietary

1500 mg elemental calcium daily in divided doses (the divided doses were 2-3 times per day depending on the formulation)

Vitamin Ddietary

800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration