CompletedNot Applicable

Prevention of Post Operative Bone Loss in Children

United States24 participantsStarted 2007-09

Plain-language 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.

Who can participate

Age range4 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan

Timeframe: Preoperative to post-operative DXA scan (4-12 weeks)

Trial details

NCT IDNCT00655681

SponsorUniversity of New Mexico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-08

Results submitted2014-02-03

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