Prevention of Post Operative Bone Loss in Children

University of New Mexico (UNM)

Status: Completed

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

Treatments: Other: saline; Drug: pamidronate

Study type: Interventional

Funder types: Other

Identifiers

NCT00655681

07-213

Details and patient eligibility

About

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.

Full 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

Enrollment: 24 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No 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

Exclusion criteria

• creatinine >1.2
• prior bisphosphonate exposure
• orthopaedic implants in distal femoral precluding DXA scan
• inability to cooperate with DXA scan

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

A recieveds pamidronate 1mg/kg once

Experimental group

Description:

Receives pamidronate 1mg/kg once

Treatment:

Drug: pamidronate

B: placebo group recieves saline

Placebo Comparator group

Description:

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

Treatment:

Other: saline