Prevention of Post Operative Bone Loss in Children
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ClinicalTrials.gov Identifier: NCT00655681 |
Recruitment Status
:
Completed
First Posted
: April 10, 2008
Last Update Posted
: March 1, 2012
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis Cerebral Palsy Spina Bifida Osteopenia Osteogenesis Imperfecta | Drug: pamidronate Other: saline | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Prevention of Post Operative Bone Loss in Children |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | August 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Receives pamidronate 1mg/kg
|
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
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Placebo Comparator: B
receives saline injection
|
Other: saline
receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids
Other Name: normal saline
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- Amount of bone density lost (%) from pre-to post-operative DXA scan [ Time Frame: Preoperative to post-operative DXA scan (4-12 weeks) ]
- Post operative fractures of lower extremity [ Time Frame: 1 year post operatively ]

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Ages Eligible for Study: | 4 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655681
United States, New Mexico | |
University of New Mexico Carrie Tingley Hospital | |
Albuquerque, New Mexico, United States, 87102 |
Principal Investigator: | Elizabeth A Szalay, MD | University of New Mexico Carrie Tingley Hospital |
Responsible Party: | Elizabeth Szalay, Professor, Pediatric Orthopaedics & Pediatrics, University of New Mexico |
ClinicalTrials.gov Identifier: | NCT00655681 History of Changes |
Other Study ID Numbers: |
07-213 |
First Posted: | April 10, 2008 Key Record Dates |
Last Update Posted: | March 1, 2012 |
Last Verified: | February 2012 |
Keywords provided by Elizabeth Szalay, University of New Mexico:
pediatric osteoporosis pediatric osteopenia pamidronate post operative osteopenia |
Additional relevant MeSH terms:
Osteoporosis Cerebral Palsy Bone Diseases, Metabolic Osteogenesis Imperfecta Spinal Dysraphism Bone Diseases Musculoskeletal Diseases Metabolic Diseases Brain Damage, Chronic Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Osteochondrodysplasias Bone Diseases, Developmental Genetic Diseases, Inborn Collagen Diseases Connective Tissue Diseases Neural Tube Defects Nervous System Malformations Congenital Abnormalities |