N/A N=22 Randomized Quadruple-blind Prevention

Prevention of Post Operative Bone Loss in Children

Osteoporosis · Cerebral Palsy · Spina Bifida · Osteopenia · Osteogenesis Imperfecta

Bottom Line

View on ClinicalTrials.gov: NCT00655681 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan — 0.043; -0.025 percent change

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: pamidronate (Drug); saline (Other)
Age: Pediatric, Adult · 4+ yrs
Sex: All
Sponsor: University of New Mexico
Primary completion: Aug 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan	0.043; -0.025	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT00655681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.