Clin Osteol 2014; 19(2-3): 52-60
Adherence to Aclasta® (SPC): results of a non-interventional clinical trialCase reports
Aim: The Adherence To Aclasta® Summary of Product Characteristics (SPC) study (ATLAS) evaluated the effect of adherence to treat ment specifications provided in SPC in reducing the potential adverse events (AEs) in patients with osteoporosis.
Materials and Methods: This was a 24-month, multicentre, non-interventional study designed in patients (> 18 years) diagnosed with post-menopausal or glucocorticoid-induced osteoporosis indicated to zoledronic acid treatment. During four follow-ups in 2 years, pa tients were given three infusions of zoledronic acid (once yearly) in accordance with standard clinical practice. Primary assessments were percentage of patients who underwent standard procedures specified in SPC, such as measurement of serum creatinine and cal cium, adequate hydration and need for acute dental surgery/treatment. Time of zoledronic acid infusion and administration of para cetamol or ibuprofen were also measur with the SPC and the quality of life.
Results: Of the 585 patients enrolled in the study, 569 patients were analysed. Serum creatinine was examined in 515 (90.5 %), 252 (85.7 %) and 101 (78.3 %) patients and serum calcium in 500 (87.9 %), 245 (83.7 %) and 102 (79.1 %) patients before first, second and third infusions, respectively. All the patients were examined for hydration before each infusion. Almost all patients were given zoledronic acid infusion for at least 15 minutes. Only few patients were administered with paracetamol, ibuprofen shortly after zoledronic acid infusion. A total of 48 AEs were reported after the first infusion, two AEs after the second infusion and none after the third infusion.
Conclusion: The results show a satisfactory compliance with instructions specified in Aclasta® SPC. The inci decreased on repeated infusion of zoledronic acid.
Keywords: osteoporosis, adherence to Summary ofProduct Characteristics (SPC), bisfosfonates, Aclasta®, study (ATLAS) Osteologický bulletin 2014;19(2-3):52-60
Published: December 11, 2014 Show citation
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