Prevention of Post Operative Bone Loss in Children

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ClinicalTrials.gov Identifier: NCT00655681

Recruitment Status : Completed

First Posted : April 10, 2008

Last Update Posted : March 1, 2012

Sponsor:

Collaborator:

Thrasher Research Fund

Information provided by (Responsible Party):

Elizabeth Szalay, University of New Mexico

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	Not Applicable

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 (Clinical Trial)
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 :	September 2007
Actual Primary Completion Date :	August 2011
Actual Study Completion Date :	August 2011

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Osteogenesis imperfecta Spina bifida

Genetic and Rare Diseases Information Center resources: Osteogenesis Imperfecta Spina Bifida Juvenile Osteoporosis Mucopolysaccharidosis Type IV

U.S. FDA Resources

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 Name: 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 Name: 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 Name: 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 Name: normal saline

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	4 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655681

Locations


United States, New Mexico
University of New Mexico Carrie Tingley Hospital
Albuquerque, New Mexico, United States, 87102

Sponsors and Collaborators

University of New Mexico

Thrasher Research Fund

Investigators


Principal Investigator:	Elizabeth A Szalay, MD	University of New Mexico Carrie Tingley Hospital

More Information


Responsible Party:	Elizabeth Szalay, Professor, Pediatric Orthopaedics & Pediatrics, University of New Mexico
ClinicalTrials.gov Identifier:	NCT00655681 History of Changes
Other Study ID Numbers:	07-213
First Posted:	April 10, 2008 Key Record Dates
Last Update Posted:	March 1, 2012
Last Verified:	February 2012

Keywords provided by Elizabeth Szalay, University of New Mexico:


pediatric osteoporosis pediatric osteopenia pamidronate post operative osteopenia

Additional relevant MeSH terms:


Osteoporosis Cerebral Palsy Bone Diseases, Metabolic Osteogenesis Imperfecta Spinal Dysraphism Bone Diseases Musculoskeletal Diseases Metabolic Diseases Brain Damage, Chronic Brain Diseases	Central Nervous System Diseases Nervous System Diseases Osteochondrodysplasias Bone Diseases, Developmental Genetic Diseases, Inborn Collagen Diseases Connective Tissue Diseases Neural Tube Defects Nervous System Malformations Congenital Abnormalities

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