An interventional study of pamidronate and saline in Osteoporosis, Cerebral Palsy and Spina Bifida, sponsored by University of New Mexico. Completed at 1 site in United States. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by University of New Mexico · Not applicable, Interventional, and Prevention
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
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's enrollment of 24 is below the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →University of New Mexico is the lead sponsor of 313 studies on the registry; 29 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Receives pamidronate 1mg/kg once
Drug: pamidronate
receives saline injection 10 cc/kg over 4 hours once post operatively
Other: saline
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.
Also known as: Aredia
receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids
Also known as: normal saline
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
Time frame: Preoperative to post-operative DXA scan (4-12 weeks)
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.
| Milestone | A Patients Receiving Pamidronate | B Patients Receiving Saline (Control Placebo) |
|---|---|---|
| Started | 12 | 10 |
| Completed | 11 | 9 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
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
| percent change | A Patients Receiving Pamidronate | B Patients Receiving Saline (Control Placebo) |
|---|---|---|
| Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan | 0.043 ± 0.04 | -0.025 ± 0.02 |
Collected over no adverse event encountered in 4 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A: Receives Pamidronate 1mg/kg | — | 0/11 (0%) | 0/11 (0%) |
| B: Receives Saline 10cc/kg Over 4 Hours Post Operatively | — | 0/9 (0%) | 0/9 (0%) |
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
| Age, Continuous(years) | A: Recieved Pamidronate 1mg/kg | B: Receives Saline 10cc/kg | Total |
|---|---|---|---|
| Mean | 9.1 (4 to 14) | 7.8 (4 to 12) | 8.5 (4 to 14) |
| Age, Categorical(Participants) | A: Recieved Pamidronate 1mg/kg | B: Receives Saline 10cc/kg | Total |
|---|---|---|---|
| <=18 years | 11 | 9 | 20 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | A: Recieved Pamidronate 1mg/kg | B: Receives Saline 10cc/kg | Total |
|---|---|---|---|
| Female | 4 | 8 | 12 |
| Male | 7 | 1 | 8 |
| Region of Enrollment(participants) | A: Recieved Pamidronate 1mg/kg | B: Receives Saline 10cc/kg | Total |
|---|---|---|---|
| United States | 11 | 9 | 20 |
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pamidronate