Skip to main content
OpenTrials
Completed

NCT Number: NCT00655681

Prevention of Post Operative Bone Loss in Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Developmental Bone Diseases, Metabolic Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Genetic Diseases, Inborn Juvenile osteoporosis Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Nervous System Malformations Neural Tube Defects Nutritional and Metabolic Diseases Osteochondrodysplasias Osteogenesis Imperfecta Osteopenia Skin and Connective Tissue Diseases Spina Bifida Spinal Dysraphism

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico Carrie Tingley Hospital

Albuquerque, New Mexico, 87102, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Aredia

Saline

Other

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

Other names: normal saline

Primary outcomes

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

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

    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

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • Thrasher Research Fund

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Apr 10, 2008
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.