NCT00655681

Prevention of Post Operative Bone Loss in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Osteoporosis
• Cerebral Palsy
• Spina Bifida
• Osteopenia
• Osteogenesis Imperfecta

Interventions

Type	Name	Description
DRUG	pamidronate	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.
OTHER	saline	receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids

Timeline

• Start date: 2007-09-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2008-04-10
• Last updated: 2023-08-22
• Results posted: 2023-08-22

Locations

1 site across 1 country: United States