Prevention of Post Operative Bone Loss in Children

Study Overview
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Brief Summary
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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
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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

Official Title
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Prevention of Post Operative Bone Loss in Children

Conditions
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Osteoporosis, Cerebral Palsy, Spina Bifida, Osteopenia, Osteogenesis Imperfecta

Intervention / Treatment
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* Drug: pamidronate
* Other: saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A recieveds pamidronate 1mg/kg once<br>Receives pamidronate 1mg/kg once | Drug: pamidronate<br>* 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.<br>* Other names: Aredia;|
| Placebo Comparator: B: placebo group recieves saline<br>receives saline injection 10 cc/kg over 4 hours once post operatively | Other: saline<br>* receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids<br>* Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan | 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 | Preoperative to post-operative DXA scan (4-12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric osteoporosis, pediatric osteopenia, pamidronate, post operative osteopenia