Conditions: Osteoporosis Cerebral Palsy Spina Bifida Osteopenia Osteogenesis Imperfecta
Keywords: pediatric osteoporosis pediatric osteopenia pamidronate post operative osteopenia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 24
Healthy volunteers: no

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

Arms:
arm 1: Receives pamidronate 1mg/kg once arm 2: receives saline injection 10 cc/kg over 4 hours once post operatively

Interventions: intervention 1: pamidronate intervention 2: saline
Intervention descriptions: intervention 1: 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. intervention 2: receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids

Protocol document: