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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A recieveds pamidronate 1mg/kg once | Experimental | Receives pamidronate 1mg/kg once |
|
| B: placebo group recieves saline | Placebo Comparator | receives saline injection 10 cc/kg over 4 hours once post operatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Szalay, MD | University of New Mexico Carrie Tingley Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Carrie Tingley Hospital | Albuquerque | New Mexico | 87102 | United States |
2 subjects were not administered drug due to slightly low serum calcium, and two did not return for the final DXA scan
Between 2007 and 2011, twenty-four subjects were enrolled, and 20 were included in the final analysis (2 subjects were not administered drug due to slightly low serum calcium, and two did not return for the final dual energy x-ray absorptiometry (DXA) scan). There were 11 subjects randomized into the treatment group and 9 into the control group.
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| ID | Title | Description |
|---|---|---|
| FG000 | A Patients Receiving Pamidronate | Receives pamidronate 1mg/kg IV once during the post operative period. Pamidronate is given over 4 hours. |
| FG001 | B Patients Receiving Saline (Control Placebo) | receives saline injection IV once in the post operative period in addition to routine post operative fluids. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Children at risk for low bone density who were to undergo orthopaedic surgical procedure that would result in cast immobilization or non weight bearing for at least 4 weeks
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| ID | Title | Description |
|---|---|---|
| BG000 | A: Recieved Pamidronate 1mg/kg | Receives pamidronate 1mg/kg IV once. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | percent change | Preoperative to post-operative DXA scan (4-12 weeks) |
|
no adverse event encountered in 4 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A: Receives Pamidronate 1mg/kg | Receives pamidronate 1mg/kg : 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth A. Szalay MD | University of New Mexico Carrie Tingley Hospital | 505 272-5214 | eszalay@salud.unm.edu |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D002547 | Cerebral Palsy |
| D016135 | Spinal Dysraphism |
| D001851 | Bone Diseases, Metabolic |
| D010013 | Osteogenesis Imperfecta |
| C537700 | Juvenile osteoporosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077268 | Pamidronate |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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|
|
| saline | Other | receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids |
|
|
| BG001 | B: Receives Saline 10cc/kg | receives saline injection IV once 10cc/kg over 4 hours post operatively in addition to routine post operative fluids |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | B: Receives Saline 10cc/kg Over 4 Hours Post Operatively | receives saline injection: receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids | 0 | 9 | 0 | 9 |
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| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |