Prevention of Post Operative Bone Loss in Children

Cerebral Palsy Clinical Trial

Official title:

Prevention of Post Operative Bone Loss in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655681
• Other study ID #: 07-213
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Est. completion date: August 2011

Study information

• Verified date: July 2023
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Cerebral Palsy
• Osteogenesis Imperfecta
• Osteopenia
• Osteoporosis
• Spina Bifida
• Spinal Dysraphism

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:
• saline
receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids

Locations

Country	Name	City	State
United States	University of New Mexico Carrie Tingley Hospital	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan	Mean change lumbar spine post-op BMD Mean Right metaphyseal femur change post op BMD Mean Right transitional femur change post op BMD Mean Right diaphyseal femur change post op BMD; Mean Left metaphyseal femur change post op BMD Mean Left transitional femur change post op BMD Mean Left diaphyseal femur change post op BMD	Preoperative to post-operative DXA scan (4-12 weeks)