Prevention of Post Operative Bone Loss in Children

• ClinicalTrials.gov Identifier: NCT00655681
• Recruitment Status: Completed
• First Posted: April 10, 2008
• Last Update Posted: March 1, 2012
• Sponsor: University of New Mexico
• Collaborator: Thrasher Research Fund
• Information provided by (Responsible Party): Elizabeth Szalay, University of New Mexico

Tracking Information

• First Submitted Date: April 4, 2008
• First Posted Date: April 10, 2008
• Last Update Posted Date: March 1, 2012
• Study Start Date: September 2007
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 9, 2008): Amount of bone density lost (%) from pre-to post-operative DXA scan [ Time Frame: Preoperative to post-operative DXA scan (4-12 weeks) ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: April 9, 2008): Post operative fractures of lower extremity [ Time Frame: 1 year post operatively ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prevention of Post Operative Bone Loss in Children
• Official Title: Prevention of Post Operative Bone Loss in Children

Brief 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.

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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

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

Intervention

• Drug: pamidronate
  The pamidronate is mixed 1 to 10 (10 cc of saline for each 1 mg pamidronate), with a minimum volume of 50 cc saline. The medication is administered as an IV infusion to run at a rate beginning at 20 cc/hr, adjusting the rate so that the infusion will run over 4 hours. For children < 8 kg (80cc infusion), the rate would be 20 cc/hr and the duration would be determined by the volume.
  Other Name: Aredia
• Other: saline
  receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids
  Other Name: normal saline

Study Arms

• Experimental: A
  Receives pamidronate 1mg/kg
  Intervention: Drug: pamidronate
• Placebo Comparator: B
  receives saline injection
  Intervention: Other: saline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 29, 2012): 24
• Original Estimated Enrollment (submitted: April 9, 2008): 28
• Actual Study Completion Date: August 2011
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 4 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00655681
• Other Study ID Numbers: 07-213
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Elizabeth Szalay, University of New Mexico
• Study Sponsor: University of New Mexico
• Collaborators: Thrasher Research Fund

Investigators

• Principal Investigator: Elizabeth A Szalay, MD; University of New Mexico Carrie Tingley Hospital

• PRS Account: University of New Mexico
• Verification Date: February 2012