Prevention of Post Operative Bone Loss in Children
Information source: University of New Mexico
Information obtained from ClinicalTrials.gov on November 03, 2008
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: Recruiting
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
Overall contact:
Elizabeth A Szalay, MD, Phone: 505 272-5214, Email: ESzalay@salud.unm.edu
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: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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
Preop 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
Elizabeth A Szalay, MD, Phone: 505 272-5214, Email: ESzalay@salud.unm.edu
University of New Mexico Carrie Tingley Hospital, Albuquerque, New Mexico 87102, United States; Recruiting
Additional Information
Starting date: September 2007
Ending date: February 2010
Last updated: April 9, 2008
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