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Complications of pamidronate therapy in paediatric osteoporosis
Sanjay K Chilbule1, Vrisha Madhuri
1Paediatric Orthopaedics Unit, Department of Orthopaedics, Christian Medical College, Vellore, 632004 Tamil Nadu India.
Insights
Pamidronate treatment for pediatric osteoporosis has complications, with higher doses increasing risks. Adjusting infusion frequency and dose can mitigate these adverse events, improving patient safety.
Area of Science:
- Pediatric Endocrinology
- Pharmacovigilance
- Orthopedic Surgery
Background:
- Pamidronate is a bisphosphonate used to treat pediatric osteoporosis, known to reduce fractures and improve mobility.
- However, intravenous pamidronate therapy carries potential complications that require careful stratification based on dosage and administration.
Purpose of the Study:
- To assess early minor and major medical complications associated with intravenous pamidronate in pediatric osteoporosis.
- To evaluate late surgical complications and their relationship to pamidronate dosage and infusion regimens.
- To determine the effect of different pamidronate infusion regimens on the incidence of adverse events.
Main Methods:
- A retrospective cohort study was conducted over 10 years.
- Three sequential pamidronate infusion regimens (A, B, and C) with varying doses and frequencies were analyzed.
- Adverse events were categorized as early (minor/major medical) or late (surgical).
Main Results:
- Twenty-nine complications occurred in 24 of 48 children (50%) receiving 158 infusions.
- A significant difference in complication rates was observed among the three regimens (P=0.005).
- Higher doses (Regimen B) were associated with major complications, including seizures and hypocalcemic tetany. Surgical complications, such as bone splintering during rush rodding, were 5.4 times higher in patients who received pamidronate.
Conclusions:
- Intravenous pamidronate is associated with a dose-dependent complication rate in pediatric osteoporosis.
- Major complications can be reduced by optimizing the infusion regimen (more frequent, lower doses per cycle).
- Surgical difficulties, like bone splintering, may be mitigated by correcting deformities before pamidronate therapy.
Purpose:
Pamidronate, used for the treatment of paediatric osteoporosis, reduces the fracture rate and improves ambulatory status. Intravenous pamidronate therapy has known complications which have not been stratified based on its dose and distribution. This study aims to assess the early minor and major medical and late surgical complications and the effect of the dose and regimen of infusion on these events in paediatric osteoporosis.
Study Design:
Retrospective cohort.
Materials And Methods:
Three regimens for pamidronate infusion were followed in sequential periods in 10 years. Regimen A delivered 1.5 mg/kg/day as a single dose once in 3 months. Regimen B delivered 2 mg/kg/day for 3 days twice a year, while regimen C delivered 1 mg/kg/day for 3 days every 3-4 months. Adverse events were classified as early (major and minor) or late (surgical).
Results:
Forty-eight children received 158 infusions using one of the three regimens. Twenty-nine complications occurred in 24 children. A significant difference in the complication rate was present among the three regimens (P = 0.005). Nineteen children had minor complications, mainly febrile reaction or asymptomatic hypocalcaemia. Four major complications consisting of one seizure, one respiratory distress and two hypocalcaemic tetany were encountered, all with regimen B. Intraoperative complication faced was loss of position due to splintering of the cortex while rush rodding. This was seen in 20% of the long bone segments operated in those who received pamidronate as compared to 4.4% of the segments which were operated prior to the initiation of pamidronate therapy; the odds of splintering were 5.4 times higher for those patients who were bone segment rodded after pamidronate therapy.
Discussion:
Intravenous pamidronate is associated with complications in 50% of children with paediatric osteoporosis, with a dose-dependent significant difference. Major complications are not uncommon with higher doses and can be avoided by increasing the number of doses per year and decreasing the dose per cycle. Surgical difficulty, when possible, can be avoided by correcting any major deformities at presentation prior to the induction of pamidronate therapy.
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