Prevention of Post Operative Bone Loss in Children

Not Applicable

Completed

• Conditions: Osteoporosis; Spina Bifida; Cerebral Palsy; Osteogenesis Imperfecta; Osteopenia
• Interventions: Other: saline; Drug: pamidronate

• Registration Number: NCT00655681
• Lead Sponsor: University of New Mexico

Brief 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.

Detailed Description

Children at risk for post operative bone loss will be studied with preoperative DXA scan of spine and distal femora

Preoperative screening with standard labs electrolytes, Ca++, PO4, creatinine, Vit D

Following surgery of hip(s) or lower extremities, randomization into treatment with low dose IV pamidronate (one dose) v placebo group

Repeat DXA scan after end of immobilization or non-weightbearing

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-09
• Study First Posted: 2008-04-10
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2014-02-03
• Status Verified: 2023-07
• Results First Submitted QC: 2023-08-01
• Last Update Submitted: 2023-08-01
• Results First Posted: 2023-08-22
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• chronic condition predisposing to low bone density, such as cerebral palsy, osteogenesis imperfecta
• lower extremity surgery proposed that will require post op nonweightbearing, casted or not, for a minimum of 4 weeks

Exclusion Criteria

• creatinine >1.2
• prior bisphosphonate exposure
• orthopaedic implants in distal femoral precluding DXA scan
• inability to cooperate with DXA scan

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B: placebo group recieves saline	saline	receives saline injection 10 cc/kg over 4 hours once post operatively
A recieveds pamidronate 1mg/kg once	pamidronate	Receives pamidronate 1mg/kg once

Primary Outcome Measures

Name	Time	Method
Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan	Preoperative to post-operative DXA scan (4-12 weeks)	Mean change lumbar spine post-op BMD Mean Right metaphyseal femur change post op BMD Mean Right transitional femur change post op BMD Mean Right diaphyseal femur change post op BMD; Mean Left metaphyseal femur change post op BMD Mean Left transitional femur change post op BMD Mean Left diaphyseal femur change post op BMD

Trial Locations

Locations (1)

University of New Mexico Carrie Tingley Hospital; 🇺🇸 Albuquerque, New Mexico, United States