Text Size

Prevention of Post Operative Bone Loss in Children

This study has been completed.
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Elizabeth Szalay, University of New Mexico
ClinicalTrials.gov Identifier:
NCT00655681
First received: April 4, 2008
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  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:

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 ]

Enrollment: 24
Study Start Date: September 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (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

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

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

No publications provided

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
Study First Received: April 4, 2008
Last Updated: February 29, 2012
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:
Spinal Dysraphism
Cerebral Palsy
Osteogenesis Imperfecta
Bone Diseases, Metabolic
Osteoporosis
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 May 22, 2013