Prevention of Post Operative Bone Loss in Children
This study has been completed.
Sponsor:
University of New Mexico
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Elizabeth Szalay, University of New Mexico
ClinicalTrials.gov Identifier:
NCT00655681
First received: April 4, 2008
Last updated: February 29, 2012
Last verified: February 2012
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Purpose
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 | Intervention |
|---|---|
|
Osteoporosis Cerebral Palsy Spina Bifida Osteopenia Osteogenesis Imperfecta |
Drug: pamidronate Other: saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Prevention of Post Operative Bone Loss in Children |
Resource links provided by NLM:
Genetics Home Reference related topics:
mucopolysaccharidosis type IV
osteogenesis imperfecta
spina bifida
Genetic and Rare Diseases Information Center resources:
Cerebral Palsy
Osteogenesis Imperfecta
Osteogenesis Imperfecta Type 2B
Spina Bifida
U.S. FDA Resources
Further study details as provided by University of New Mexico:
Primary Outcome Measures:
- Amount of bone density lost (%) from pre-to post-operative DXA scan [ Time Frame: Preoperative to post-operative DXA scan (4-12 weeks) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Post operative fractures of lower extremity [ Time Frame: 1 year post operatively ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | September 2007 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
|
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
|
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
Eligibility| Ages Eligible for Study: | 4 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655681
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655681
Locations
| United States, New Mexico | |
| University of New Mexico Carrie Tingley Hospital | |
| Albuquerque, New Mexico, United States, 87102 | |
Sponsors and Collaborators
University of New Mexico
Thrasher Research Fund
Investigators
| Principal Investigator: | Elizabeth A Szalay, MD | University of New Mexico Carrie Tingley Hospital |
More Information
No publications provided
| 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 |
| Study First Received: | April 4, 2008 |
| Last Updated: | February 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of New Mexico:
|
pediatric osteoporosis pediatric osteopenia pamidronate post operative osteopenia |
Additional relevant MeSH terms:
|
Osteogenesis Imperfecta Bone Diseases Bone Diseases, Developmental Collagen Diseases |
Connective Tissue Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Osteochondrodysplasias |
ClinicalTrials.gov processed this record on March 03, 2015