Feasibility and Safety of Establishing a Bisphosphonate Infusion Program in a Pediatric Orthopedic Department: A Ten-Year Experience

Autor: Laura L. Tosi, Christina M. Dollar, Lindsey Weigley, Mirini Kim, Marianne Floor, Austin P. Gillies
Rok vydání: 2018
Předmět:
Zdroj: Journal of Clinical Densitometry. 21:603
ISSN: 1094-6950
Popis: Introduction Bisphosphonates have been shown to increase bone mineral density (BMD) in adult osteoporosis patients and are potentially useful in pediatric patients with significantly reduced BMD due to chronic illness and musculoskeletal disorders. While the long term efficacy of this therapy is still being elucidated, safety remains underreported. Objectives Bisphosphonates (BPs) are increasingly offered to children with chronic illness and low BMD. We present insights into the feasibility and safety of providing BPs in a pediatric orthopaedic department based on our 10-year experience. Methods We performed an IRB-approved retrospective chart-review of patients who received BP therapy between June 2007 and July 2017. Charts were reviewed for treatment, demographics, number of infusions and therapy length. All adverse events (AEs) related to infusions within 7 days were recorded. These were categorized as “mild”: an acute phase reaction (APR): fever, nausea, muscle aches, malaise, vomiting; or “serious”: symptomatic hypocalcemia or respiratory distress. Results 121 patients (63% male; median age at first infusion 8.6 yrs; range 0.01-23.4 yrs) with skeletal disorders received 794 infusions (85% pamidronate, 15% zoledronic acid). The most common patient diagnoses were osteogenesis imperfecta 31.1%, cerebral palsy 14.8%, and muscular dystrophy 12.3%. While the majority of patients were treated for severely low bone density and fracture or fracture risk, other indications included palliative care for bone pain (5) and participation in a protocol for Gorham-Stout (3) or tibial pseudarthrosis (1). 68/794 (8.6%) infusions in 40/121 (33%) patients had reported AEs. Most AEs were APRs, typically, but not always, occurring on the first or second infusion, 28/40 patients with AEs; 3 patients required readmission; 7/8 patients with hypocalcemia were managed at home under the supervision of our NP or during their infusion. Some patients developed both mild and serious AE's. No patients required ICU admission or expired. Conclusion We demonstrate that a BP infusion program incorporated into orthopaedic care of children is feasible and safe. We found that mild AEs are fairly common following BP therapy in children; however the incidence of serious AEs is acceptably low. Given the risk of post-treatment hypocalcemia we suggest performing post-infusion patient assessments for at least 3 days.
Databáze: OpenAIRE