CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
pamidronate +1 moredrug
Likely dose
pamidronate 1 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/NCT00655681
NCT00655681N/ACompleted
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Prevention of Post Operative Bone Loss in Children

University of New Mexico·interventional·Posted Apr 10, 2008·Updated Aug 22, 2023

In Brief

A clinical study evaluating pamidronate and saline for Osteoporosis and 4 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Hypothesis: one-dose pamidronate will prevent post-operative bone loss in children at risk for low bone density Plan: children with chronic disease such as CP, spina bifida, etc. will be recruited pre operatively and studied with DXA scan. After surgery, children will be randomized to receive either pamidronate or saline. Repeat DXA scan will determine bone lost after end of immobilization or nonweightbearing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Cerebral Palsy, Spina Bifida, Osteopenia, Osteogenesis Imperfecta
CountriesUnited States
CollaboratorsThrasher Research Fund

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 10, 2008
Enrollment StartSep 1, 2007
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 18.2 years ago

Interventions

pamidronatedrug

The pamidronate is mixed 1 to 10 (10 cc of saline for each 1 mg pamidronate), with a minimum volume of 50 cc saline. The medication is administered as an IV infusion to run at a rate beginning at 20 cc/hr, adjusting the rate so that the infusion will run over 4 hours. For children \< 8 kg (80cc infusion), the rate would be 20 cc/hr and the duration would be determined by the volume.

salineother

receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids