Prevention of Post Operative Bone Loss in Children

Sponsor

University of New Mexico (Other)

Overall Status

Completed

CT.gov ID

NCT00655681

Collaborator

Thrasher Research Fund (Other)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Cerebral Palsy Spina Bifida Osteopenia Osteogenesis Imperfecta	Drug: pamidronate Other: saline	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Prevention of Post Operative Bone Loss in Children

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Receives pamidronate 1mg/kg	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 Names: Aredia
Placebo Comparator: B receives saline injection	Other: saline receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids Other Names: normal saline

Arm

Intervention/Treatment

Experimental: A

Receives pamidronate 1mg/kg

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 Names:

Aredia

Placebo Comparator: B

receives saline injection

Other: saline

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

Other Names:

normal saline

Outcome Measures

Primary Outcome Measures

Amount of bone density lost (%) from pre-to post-operative DXA scan [Preoperative to post-operative DXA scan (4-12 weeks)]

Secondary Outcome Measures

Post operative fractures of lower extremity [1 year post operatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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