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Prevention of Post Operative Bone Loss in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00655681
First Posted: April 10, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Elizabeth Szalay, University of New Mexico
  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
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

Resource links provided by NLM:


Further study details as provided by Elizabeth Szalay, 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) ]

Secondary Outcome Measures:
  • Post operative fractures of lower extremity [ Time Frame: 1 year post operatively ]

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

Information from the National Library of Medicine

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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
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
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 Submitted: April 4, 2008
First Posted: April 10, 2008
Last Update Posted: October 12, 2017
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:
Osteogenesis Imperfecta
Osteoporosis
Cerebral Palsy
Bone Diseases, Metabolic
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