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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
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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
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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


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 :
  1. 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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Information from the National Library of Medicine

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
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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
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Principal Investigator: Elizabeth A Szalay, MD University of New Mexico Carrie Tingley Hospital
More Information
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Responsible Party: Elizabeth Szalay, Professor, Pediatric Orthopaedics & Pediatrics, University of New Mexico
ClinicalTrials.gov Identifier: NCT00655681    
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:
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Osteoporosis
Bone Diseases, Metabolic
Osteogenesis Imperfecta
Cerebral Palsy
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
Pamidronate
Bone Density Conservation Agents
Physiological Effects of Drugs