Prevention of Post Operative Bone Loss in Children



Status:Completed
Conditions:Osteoporosis, Neurology, Orthopedic, Gastrointestinal
Therapuetic Areas:Gastroenterology, Neurology, Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:4 - 18
Updated:10/14/2017
Start Date:September 2007
End Date:August 2011

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Trial Summary
Trial Overview
Inclusion Criteria
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.

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

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
We found this trial at
1
site
University of New Mexico Carrie Tingley Hospital
1127 University Boulevard Northeast
Albuquerque, New Mexico 87102
?
mi
from
Albuquerque, NM
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