DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A randomized, double-blind comparison of risedronate and etidronate in the treatment of Paget's disease of bone. Paget's Risedronate/Etidronate Study Group.

Author(s): Miller PD, Brown JP, Siris ES, Hoseyni MS, Axelrod DW, Bekker PJ

Affiliation(s): Colorado Center for Bone Research, Lakewood 80227, USA.

Publication date & source: 1999-05, Am J Med., 106(5):513-20.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

PURPOSE: 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. 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 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. Reductions in pain were statistically 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 reductions in pain, and provides additional remission in subjects who exhibited an incomplete response to previous etidronate treatment.

Page last updated: 2006-01-31

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017