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Prevention of Post Operative Bone Loss in Children

Information source: University of New Mexico
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis; Cerebral Palsy; Spina Bifida; Osteopenia; Osteogenesis Imperfecta

Intervention: pamidronate (Drug); saline (Other)

Phase: N/A

Status: Completed

Sponsored by: University of New Mexico

Official(s) and/or principal investigator(s):
Elizabeth A Szalay, MD, Principal Investigator, Affiliation: University of New Mexico Carrie Tingley Hospital

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.

Clinical Details

Official title: Prevention of Post Operative Bone Loss in Children

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Amount of bone density lost (%) from pre-to post-operative DXA scan

Secondary outcome: Post operative fractures of lower extremity

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

Minimum age: 4 Years. Maximum age: 18 Years. Gender(s): Both.

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

Locations and Contacts

University of New Mexico Carrie Tingley Hospital, Albuquerque, New Mexico 87102, United States
Additional Information

Starting date: September 2007
Last updated: February 29, 2012

Page last updated: August 20, 2015

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