ECTS2013 Poster Presentations Other diseases of bone and mineral metabolism (48 abstracts)
Zoledronate efficacy and safety in active Paget's disease: long-term follow-up and retreatment in clinical practice
Elsa Vieira-Sousa 1, , Ana Rodrigues 1, , Joana Caetano-Lopes 2 , Susana Capela 1 , Filipa Ramos 1 , Ricardo Figueira 1 , Joaquim Polido-Pereira1 1 , Cristina Ponte 1, , Raquel Campanilho-Marques1 1, , Rita Barros 1 , José Carlos Romeu 1 & José Alberto Pereira da Silva 1
1Rheumatology and Metabolic Bone Diseases Department, Santa Maria Hospital, CHLN, Lisbon, Portugal; 2Rheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal.
Background: Zoledronate, a third generation bisphosphonate, has showed high efficacy in the inhibition of bone resorption. The objective of this observational study was to assess short and long-term efficacy and safety of zoledronate in the treatment of active Paget’s disease (PD).
Methods: Patients with active PD treated with zoledronate 5 mg were consecutively recruited. Clinical and laboratory parameters were determined before, at 3 and every 6 months after treatment. Remission was defined as normalization of alkaline phosphatase.
Results: 60 patients, with mean disease duration of 11±9 years were included. 69% had polyostotic disease and a mean percentage of skeletal involvement of 10.8±7.6%. 68% were symptomatic: 71% of those referring bone and 54% joint pain attributed to PD. 48.3% had been previously treated with parental pamidronate, with a cumulative dose of 234±209 mg. The mean follow-up period after zoledronate infusion was of 37±13 months (minimum of 12 and maximum of 60). Only four patients (6.6%) required retreatment, on average 30 months after the first zoledronate infusion. A significant reduction of alkaline phosphatase was observed at 3 and 6 months after zoledronate administration, being maximal at 12 months (P<0.001). At 3 and 6 months, 95 and 96% of patients, respectively, achieved remission. Maximum effect was obtained at 12 months after treatment with 98% of patients being in remission. Significant reductions of the mean levels of bone specific alkaline phosphatase, procollagen type 1 N-terminal propeptide, and collagen type 1β C-terminal telopeptide (P<0.001) were also verified at 3, 6, and 12 months after treatment. 47% of patients reported pain improvement: 89% at 3 months. Transitory side effects were registered in 15 patients, 18% referred flu-like symptoms and 10% showed asymptomatic hypocalcaemia.
Conclusions: This study confirms the efficacy and safety of zoledronate in a Portuguese population of patients with active PD. Biochemical remission was achieved in 98% of patients at 12 months and improvement of pain in 47%. These benefits were long-term sustained with only 6.6% of patients requiring retreatment during an average follow-up of 37 months.
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