Cerebral Palsy, Osteogenesis Imperfecta, Osteopenia, Osteoporosis, Spina Bifida
Conditions
Keywords
pediatric osteoporosis, pediatric osteopenia, pamidronate, post operative osteopenia
Brief summary
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.
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
Interventions
DRUGpamidronate
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.
OTHERsaline
receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids
Sponsors
Thrasher Research Fund
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan | Preoperative to post-operative DXA scan (4-12 weeks) | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
2 subjects were not administered drug due to slightly low serum calcium, and two did not return for the final DXA scan
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| B: Receives Saline 10cc/kg receives saline injection IV once 10cc/kg over 4 hours post operatively in addition to routine post operative fluids | 9 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | A: Recieved Pamidronate 1mg/kg | B: Receives Saline 10cc/kg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 11 Participants | 9 Participants | 20 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.1 years | 7.8 years | 8.5 years |
| Region of Enrollment United States | 11 participants | 9 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Male | 7 Participants | 1 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 9 |
| serious Total, serious adverse events | 0 / 11 | 0 / 9 |
Outcome results
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
Time frame: Preoperative to post-operative DXA scan (4-12 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Patients Receiving Pamidronate | Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan | 0.043 percent change | Standard Deviation 0.04 |
| B Patients Receiving Saline (Control Placebo) | Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan | -0.025 percent change | Standard Deviation 0.02 |