Prevention of Post Operative Bone Loss in Children - Full Text View

Sponsors and Collaborators:	University of New Mexico Thrasher Foundation
Information provided by:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT00655681

Purpose

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	Intervention
Osteoporosis Cerebral Palsy Spina Bifida Osteopenia Osteogenesis Imperfecta	Drug: pamidronate Other: saline

Genetics Home Reference related topics: Melnick-Needles syndrome osteogenesis imperfecta

MedlinePlus related topics: Cerebral Palsy Nuclear Scans Osteogenesis Imperfecta Osteoporosis Spina Bifida

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Prevention of Post Operative Bone Loss in Children

Further study details as provided by University of New Mexico:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Post operative fractures of lower extremity [ Time Frame: 1 year post operatively ] [ Designated as safety issue: No ]

Estimated Enrollment:	28
Study Start Date:	September 2007
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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.
B: Placebo Comparator receives saline injection	Other: saline receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids

Arms

Assigned Interventions

A: Experimental

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.

B: Placebo Comparator

receives saline injection

Other: saline

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

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

Eligibility

Ages Eligible for Study:	4 Years to 18 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655681

Contacts

Contact: Elizabeth A Szalay, MD	505 272-5214	ESzalay@salud.unm.edu
Contact: Jude McMullan	505 272-5214	JMcMullan@salud.unm.edu

Locations

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

Sponsors and Collaborators

University of New Mexico

Thrasher Foundation

Investigators

Principal Investigator:

Elizabeth A Szalay, MD

University of New Mexico Carrie Tingley Hospital

More Information

No publications provided

Responsible Party:	University of New Mexico ( Elizabeth Szalay MD )
Study ID Numbers:	07-213
Study First Received:	April 4, 2008
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00655681 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of New Mexico:

pediatric osteoporosis
pediatric osteopenia
pamidronate
post operative osteopenia

Study placed in the following topic categories:

Neural Tube Defects
Osteogenesis Imperfecta
Collagen Diseases
Nervous System Malformations
Spinal Dysraphism
Brain Damage, Chronic
Osteochondrodysplasias
Osteoporosis
Central Nervous System Diseases
Bone Density Conservation Agents
Bone Diseases, Metabolic
Brain Diseases

Bone Diseases
Paralysis
Cerebral Palsy
Spina Bifida
Genetic Diseases, Inborn
Musculoskeletal Diseases
Connective Tissue Diseases
Bone Diseases, Developmental
Pamidronate
Congenital Abnormalities
Brain Injuries
Neural Tube Defect, Folate-sensitive

Additional relevant MeSH terms:

Neural Tube Defects
Osteogenesis Imperfecta
Collagen Diseases
Nervous System Malformations
Spinal Dysraphism
Physiological Effects of Drugs
Brain Damage, Chronic
Nervous System Diseases
Osteochondrodysplasias
Osteoporosis
Central Nervous System Diseases
Bone Density Conservation Agents

Bone Diseases, Metabolic
Brain Diseases
Bone Diseases
Pharmacologic Actions
Cerebral Palsy
Genetic Diseases, Inborn
Musculoskeletal Diseases
Connective Tissue Diseases
Bone Diseases, Developmental
Pamidronate
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 07, 2009