Prevention of Post Operative Bone Loss in Children

NCT ID: NCT00655681

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2011-08-31

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

A recieveds pamidronate 1mg/kg once

Receives pamidronate 1mg/kg once

Group Type: EXPERIMENTAL

pamidronate

Intervention Type: DRUG

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.

B: placebo group recieves saline

receives saline injection 10 cc/kg over 4 hours once post operatively

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: OTHER

receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids

Interventions

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.

Intervention Type: DRUG

saline

receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids

Intervention Type: OTHER

Other Intervention Names

Aredia; normal saline

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thrasher Research Fund

OTHER

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth A Szalay, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico Carrie Tingley Hospital

Locations

University of New Mexico Carrie Tingley Hospital

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

07-213

Identifier Type: -

Identifier Source: org_study_id