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Prevention of Post Operative Bone Loss in Children

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.
 
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

Tracking Information
First Submitted Date  ICMJE April 4, 2008
First Posted Date  ICMJE April 10, 2008
Last Update Posted Date March 1, 2012
Study Start Date  ICMJE September 2007
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
Amount of bone density lost (%) from pre-to post-operative DXA scan [ Time Frame: Preoperative to post-operative DXA scan (4-12 weeks) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
Post operative fractures of lower extremity [ Time Frame: 1 year post operatively ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Post Operative Bone Loss in Children
Official Title  ICMJE Prevention of Post Operative Bone Loss in Children
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Osteoporosis
  • Cerebral Palsy
  • Spina Bifida
  • Osteopenia
  • Osteogenesis Imperfecta
Intervention  ICMJE
  • 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
  • Other: saline
    receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids
    Other Name: normal saline
Study Arms  ICMJE
  • Experimental: A
    Receives pamidronate 1mg/kg
    Intervention: Drug: pamidronate
  • Placebo Comparator: B
    receives saline injection
    Intervention: Other: saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 29, 2012)
24
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2008)
28
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00655681
Other Study ID Numbers  ICMJE 07-213
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elizabeth Szalay, University of New Mexico
Study Sponsor  ICMJE University of New Mexico
Collaborators  ICMJE Thrasher Research Fund
Investigators  ICMJE
Principal Investigator: Elizabeth A Szalay, MD University of New Mexico Carrie Tingley Hospital
PRS Account University of New Mexico
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP