Prevention of Post Operative Bone Loss in Children

University of New Mexico24 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Osteoporosis Cerebral Palsy Spina Bifida Osteopenia Osteogenesis Imperfecta

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of New Mexico Carrie Tingley Hospital

Albuquerque, New Mexico, United States

Outcomes

Primary Outcomes

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

Time frame: Preoperative to post-operative DXA scan (4-12 weeks)

Data from ClinicalTrials.gov

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