Pd. Miller et al., A randomized, double-blind comparison of risedronate and etidronate in thetreatment of Paget's disease of bone, AM J MED, 106(5), 1999, pp. 513-520
Citations number
50
Categorie Soggetti
General & Internal Medicine","Medical Research General Topics
PURPOSE: To compare the efficacy and tolerability of oral risedronate and e
tidronate for treatment of Paget's disease of bone.
PATIENTS AND METHODS: Patients from 12 centers in North America received ri
sedronate 30 mg daily for 2 months (62 patients) or etidronate 400 mg daily
for 6 months (61 patients) in a prospective, randomized, double-blind stud
y. Serum alkaline phosphatase (the primary variable), serum bone-specific a
lkaline phosphatase, and urinary deoxypyridinoline concentrations were moni
tored for 12 to 18 months.
RESULTS: 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 risedr
onate-treated patients and >360 days for etidronate-treated patients (P < 0
.001); relapse rates were 3% in the risedronate group and 15% in the etidro
nate group (P < 0.05). At month 18, 53% of the risedronate group and 14% of
the etidronate group remained in biochemical remission. Urinary deoxypyrid
inoline normalized in 87% of patients on risedronate and 57% of patients re
ceiving etidronate (P < 0.01); serum bone-specific alkaline phosphatase nor
malized 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. Reductions in pain were sta
tistically significant in the risedronate group, but not in the etidronate
group. Both drugs were well tolerated.
CONCLUSION: Although etidronate is effective, risedronate offers a shorter
duration of therapy, better and longer-lasting remission, significant reduc
tions in pain, and provides additional remission in subjects who exhibited
an incomplete response to previous etidronate treatment. (C) 1999 by Excerp
ta Medica, Inc.