Trial Outcomes & Findings for Prevention of Post Operative Bone Loss in Children (NCT NCT00655681)
NCT ID: NCT00655681
Last Updated: 2023-08-22
Results Overview
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
COMPLETED
NA
24 participants
Preoperative to post-operative DXA scan (4-12 weeks)
2023-08-22
Participant Flow
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.
2 subjects were not administered drug due to slightly low serum calcium, and two did not return for the final DXA scan
Participant milestones
| Measure |
A Patients Receiving Pamidronate
Receives pamidronate 1mg/kg IV once during the post operative period. Pamidronate is given over 4 hours.
|
B Patients Receiving Saline (Control Placebo)
receives saline injection IV once in the post operative period in addition to routine post operative fluids.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
A Patients Receiving Pamidronate
Receives pamidronate 1mg/kg IV once during the post operative period. Pamidronate is given over 4 hours.
|
B Patients Receiving Saline (Control Placebo)
receives saline injection IV once in the post operative period in addition to routine post operative fluids.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Prevention of Post Operative Bone Loss in Children
Baseline characteristics by cohort
| Measure |
A: Recieved Pamidronate 1mg/kg
n=11 Participants
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.
|
B: Receives Saline 10cc/kg
n=9 Participants
receives saline injection IV once 10cc/kg over 4 hours post operatively in addition to routine post operative fluids
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.1 years
n=5 Participants
|
7.8 years
n=7 Participants
|
8.5 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
A Patients Receiving Pamidronate
n=11 Participants
Receives pamidronate 1mg/kg one time post operatively over 4 hours
|
B Patients Receiving Saline (Control Placebo)
n=9 Participants
receives saline injection once 10 cc/kg over 4 hours in additional to routine post op fluide
|
|---|---|---|
|
Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan
|
0.043 percent change
Standard Deviation 0.04
|
-0.025 percent change
Standard Deviation 0.02
|
Adverse Events
A: Receives Pamidronate 1mg/kg
B: Receives Saline 10cc/kg Over 4 Hours Post Operatively
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Elizabeth A. Szalay MD
University of New Mexico Carrie Tingley Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place