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| Sponsors and Collaborators: |
University of New Mexico Thrasher Foundation |
| Information provided by: | University of New Mexico |
| ClinicalTrials.gov Identifier: | NCT00655681 |
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 |
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Osteoporosis Cerebral Palsy Spina Bifida Osteopenia Osteogenesis Imperfecta |
Drug: pamidronate Other: saline |
| Genetics Home Reference related topics: | Melnick-Needles syndrome osteogenesis imperfecta |
| MedlinePlus related topics: | Cerebral Palsy Nuclear Scans Osteogenesis Imperfecta Osteoporosis Spina Bifida |
| ChemIDplus related topics: | Sodium chloride Pamidronate disodium Amidronate |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Prevention of Post Operative Bone Loss in Children |
| Estimated Enrollment: | 28 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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A: Experimental
Receives pamidronate 1mg/kg
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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.
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B: Placebo Comparator
receives saline injection
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Other: saline
receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids
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Children at risk for post operative bone loss will be studied with preoperative DXA scan of spine and distal femora
Preop 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Elizabeth A Szalay, MD | 505 272-5214 | ESzalay@salud.unm.edu |
| Contact: Jude McMullan | 505 272-5214 | JMcMullan@salud.unm.edu |
| United States, New Mexico | |||||
| University of New Mexico Carrie Tingley Hospital | Recruiting | ||||
| Albuquerque, New Mexico, United States, 87102 | |||||
| University of New Mexico |
| Thrasher Foundation |
| Principal Investigator: | Elizabeth A Szalay, MD | University of New Mexico Carrie Tingley Hospital |
More Information
| Responsible Party: | University of New Mexico ( Elizabeth Szalay MD ) |
| Study ID Numbers: | 07-213 |
| First Received: | April 4, 2008 |
| Last Updated: | April 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00655681 |
| Health Authority: | United States: Institutional Review Board |
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