Clinical trial

Prevention of Post Operative Bone Loss in Children

Name

07-213

Description

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.

Trial arms

Trial start

2007-09-01

Estimated PCD

2011-08-01

Trial end

2011-08-01

Status

Completed

Treatment

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.

Arms:

A recieveds pamidronate 1mg/kg once

Other names:

Aredia

saline

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

Arms:

B: placebo group recieves saline

Other names:

normal saline

Size

Primary endpoint

Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan

Preoperative to post-operative DXA scan (4-12 weeks)

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

Updated at

2023-08-22

1 organization

1 product

5 indications

Organization

University of New Mexico

Product

Indication

Indication

Indication

Indication

Indication

Osteogenesis Imperfecta