Prevention of Post Operative Bone Loss in Children

NCT00655681 | Completed Results DMC

• 1 other identifier: 07-213
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pediatric osteoporosis; pediatric osteopenia; pamidronate; post operative osteopenia

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

A recieveds pamidronate 1mg/kg once

EXPERIMENTAL

Receives pamidronate 1mg/kg once

Drug: pamidronate

B: placebo group recieves saline

PLACEBO COMPARATOR

receives saline injection 10 cc/kg over 4 hours once post operatively

Other: saline

Interventions

pamidronate DRUG

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.

Also known as: Aredia

A recieveds pamidronate 1mg/kg once

saline OTHER

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

Also known as: normal saline

B: placebo group recieves saline

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• creatinine \>1.2
• prior bisphosphonate exposure
• orthopaedic implants in distal femoral precluding DXA scan
• inability to cooperate with DXA scan

Sponsors & Collaborators

• University of New Mexico: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

University of New Mexico Carrie Tingley Hospital

Albuquerque, New Mexico, 87102, United States

Location

MeSH Terms

Conditions

Osteoporosis; Cerebral Palsy; Spinal Dysraphism; Bone Diseases, Metabolic; Osteogenesis Imperfecta; Juvenile osteoporosis

Interventions

Pamidronate; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteochondrodysplasias; Bone Diseases, Developmental; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Elizabeth A. Szalay MD
• Organization: University of New Mexico Carrie Tingley Hospital

eszalay@salud.unm.edu

505 272-5214

Study Officials

• Elizabeth A Szalay, MD

  University of New Mexico Carrie Tingley Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: September 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 22, 2023
• Results First Posted: August 22, 2023

Record last verified: 2023-07

Locations

US (1)