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

Sponsor:	University of New Mexico
Collaborator:	Thrasher Research Fund
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Prevention of Post Operative Bone Loss in Children

Resource links provided by NLM:

Genetics Home Reference related topics: Melnick-Needles syndrome mucopolysaccharidosis type IV osteogenesis imperfecta spina bifida

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

U.S. FDA Resources

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
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

Arms

Assigned Interventions

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

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 Research Fund

Investigators

Principal Investigator:

Elizabeth A Szalay, MD

University of New Mexico Carrie Tingley Hospital

More Information

No publications provided

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

Keywords provided by University of New Mexico:

pediatric osteoporosis
pediatric osteopenia
pamidronate
post operative osteopenia

Additional relevant MeSH terms:

Cerebral Palsy
Osteogenesis Imperfecta
Bone Diseases, Metabolic
Osteoporosis
Spinal Dysraphism
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases

Musculoskeletal Diseases
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities
Pamidronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012