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Prevention of Post Operative Bone Loss in Children

Primary Purpose

Osteoporosis, Cerebral Palsy, Spina Bifida

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pamidronate
saline
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring pediatric osteoporosis, pediatric osteopenia, pamidronate, post operative osteopenia

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of New Mexico Carrie Tingley Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A recieveds pamidronate 1mg/kg once

B: placebo group recieves saline

Arm Description

Receives pamidronate 1mg/kg once

receives saline injection 10 cc/kg over 4 hours once post operatively

Outcomes

Primary Outcome Measures

Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan
Mean change lumbar spine post-op BMD Mean Right metaphyseal femur change post op BMD Mean Right transitional femur change post op BMD Mean Right diaphyseal femur change post op BMD Mean Left metaphyseal femur change post op BMD Mean Left transitional femur change post op BMD Mean Left diaphyseal femur change post op BMD

Secondary Outcome Measures

Full Information

First Posted
April 4, 2008
Last Updated
August 1, 2023
Sponsor
University of New Mexico
Collaborators
Thrasher Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT00655681
Brief Title
Prevention of Post Operative Bone Loss in Children
Official Title
Prevention of Post Operative Bone Loss in Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico
Collaborators
Thrasher Research Fund

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Cerebral Palsy, Spina Bifida, Osteopenia, Osteogenesis Imperfecta
Keywords
pediatric osteoporosis, pediatric osteopenia, pamidronate, post operative osteopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A recieveds pamidronate 1mg/kg once
Arm Type
Experimental
Arm Description
Receives pamidronate 1mg/kg once
Arm Title
B: placebo group recieves saline
Arm Type
Placebo Comparator
Arm Description
receives saline injection 10 cc/kg over 4 hours once post operatively
Intervention Type
Drug
Intervention Name(s)
pamidronate
Other Intervention Name(s)
Aredia
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
saline
Other Intervention Name(s)
normal saline
Intervention Description
receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids
Primary Outcome Measure Information:
Title
Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan
Description
Mean change lumbar spine post-op BMD Mean Right metaphyseal femur change post op BMD Mean Right transitional femur change post op BMD Mean Right diaphyseal femur change post op BMD Mean Left metaphyseal femur change post op BMD Mean Left transitional femur change post op BMD Mean Left diaphyseal femur change post op BMD
Time Frame
Preoperative to post-operative DXA scan (4-12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Szalay, MD
Organizational Affiliation
University of New Mexico Carrie Tingley Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico Carrie Tingley Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States

12. IPD Sharing Statement

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Prevention of Post Operative Bone Loss in Children

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