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Acute Phase Reaction After First Neridronate Infusion in Children with Osteogenesis Imperfecta: An Analysis Based on
Felicitas Haselwarter1, Stefanie Stasek2, Kristina Eva Rehberg3
1Department of Pediatrics, Children's Hospital, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.
Insights
Fever and skeletal pain are common acute phase reactions after initial neridronate infusions in pediatric osteogenesis imperfecta (OI) patients. These side effects are generally self-limiting, improving within days with appropriate pain management.
Area of Science:
- Pediatric pharmacology
- Bone metabolism disorders
- Clinical trial methodology
Background:
- Bisphosphonates are the standard treatment for pediatric osteogenesis imperfecta (OI).
- Limited data exists on acute phase reactions (APRs) following initial neridronate administration in children.
Purpose of the Study:
- To assess the incidence, characteristics, and severity of APRs after the first intravenous neridronate infusion in pediatric OI patients.
- To evaluate the safety and tolerability of initial neridronate treatment in this population.
Main Methods:
- Sixty-five bisphosphonate-naïve pediatric OI patients received weight-adjusted intravenous neridronate.
- Parents used standardized questionnaires to report side effects like fever and skeletal pain.
- Data collection occurred during a brief hospitalization.
Main Results:
- Neridronate was generally well tolerated with no severe adverse events.
- Forty percent of patients experienced transient fever (12-24h onset, 1-2 day resolution).
- Forty percent reported new skeletal pain, with 60% experiencing severe pain, but scores improved within 4 days.
Conclusions:
- Fever and skeletal pain are common but self-limiting side effects of initial neridronate infusions in pediatric OI.
- Effective pain management and caregiver education are crucial for treatment adherence and patient comfort.
Background:
Bisphosphonates represent the current standard of care for the pharmacological treatment of pediatric patients with osteogenesis imperfecta (OI). However, data on acute phase reactions (APRs) after first-time administration, especially with neridronate, remain limited.
Objective:
This study evaluates the incidence, characteristics, and severity of APRs following the initial intravenous neridronate infusion in pediatric OI patients.
Methods:
Sixty-five bisphosphonate-naïve children with genetically or clinically confirmed OI received weight-adjusted intravenous neridronate during a brief hospitalization. Parents documented side effects, including fever onset/duration and skeletal pain, using standardized questionnaires.
Results:
Neridronate was generally well tolerated. No severe adverse events occurred. Forty percent of patients developed transient fever. Fever typically emerged within 12-24 h and resolved within 1-2 days. New skeletal pain was reported in 40% of patients, with 60% experiencing severe pain. Mean skeletal pain scores decreased below baseline within 4 days post-infusion. Fever duration did not differ significantly between OI types.
Conclusions:
Fever and skeletal pain are common yet self-limiting side effects after first neridronate infusion in children with OI. Adequate pain medication and caregiver education are important to improve treatment adherence and patient comfort during initiation of bisphosphonate therapy.
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