A randomized, double-blind comparison of risedronate and etidronate in the treatment of Paget's disease of bone.
To compare the efficacy and tolerability of oral risedronate and etidronate for treatment of Paget's disease of bone.
PATIENTS AND METHODS
Patients from 12 centers in North America received risedronate 30 mg daily for 2 months (62 patients) or etidronate 400 mg daily for 6 months (61 patients) in a prospective, randomized, double-blind study.
Serum alkaline phosphatase (the primary variable), serum bone-specific alkaline phosphatase, and urinary deoxypyridinoline concentrations were monitored for 12 to 18 months.
Serum alkaline phosphatase concentration normalized by month 12 in 73% of risedronate-treated patients, compared with 15% of those receiving etidronate (P<0.001).
Median time to normalization was 91 days for risedronate-treated patients and>360 days for etidronate-treated patients (P<0.001) ; relapse rates were 3% in the risedronate group and 15% in the etidronate group (P<0.05).
At month 18,53% of the risedronate group and 14% of the etidronate group remained in biochemical remission.
Urinary deoxypyridinoline normalized in 87% of patients on risedronate and 57% of patients receiving etidronate (P<0.01) ; serum bone-specific alkaline phosphatase normalized in 73% of patients on risedronate and 18% of patients on etidronate (P<0.001).
Patients who had received etidronate previously had a blunted response to etidronate, but not to risedronate. (...)
Mots-clés Pascal : Paget maladie os, Randomisation, Etude double insu, Acide risédronique, Acide étidronique, Voie orale, Tolérance, Efficacité, Etude comparative, Etude multicentrique, Sécurité, Homme, Etats Unis, Amérique du Nord, Amérique, Diphosphonique acide dérivé, Bisphosphonates, Système ostéoarticulaire pathologie, Ostéopathie, Antihypercalcémiant
Mots-clés Pascal anglais : Paget disease of bone, Randomization, Double blind study, Risedronic acid, Etidronic acid, Oral administration, Tolerance, Efficiency, Comparative study, Multicenter study, Safety, Human, United States, North America, America, Diphosphonic acid derivatives, Bisphosphonates, Diseases of the osteoarticular system, Bone disease
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 99-0279038
Code Inist : 002B02L. Création : 16/11/1999.