title: Comparison of three intravenous regimens of clodronate in Paget disease of bone.
abstract: We compared the effects of three different regimens of intravenous clodronate in a retrospective study of 60 patients with Paget disease. A total dose of 1500 mg of clodronate was given as 300 mg for 5 consecutive days (n = 20), 1500 mg as a single infusion (n = 20), or 300 mg as a single infusion for 5 consecutive months (n = 20). The response to treatment and the duration of the effect were assessed from sequential changes in the activity of serum alkaline phosphatase. Treatment with clodronate induced a significant response in 85% of patients. The response rate was comparable in patients treated with 5 daily infusions (90%), with a single infusion (75%), and with 5 monthly infusions (90%). The median duration of response from the start of treatment was 11 months for those treated with five daily infusions and 12 months for the other two regimens. At one year, 22, 40, and 44% of patients had maintained their response in the daily, single, and monthly infusion regimen, respectively (NS). Six patients (32%) treated with 5 daily infusions achieved a remission (complete response) compared with 3 patients treated with a single infusion and 5 monthly infusions, respectively (16 and 15% respectively, NS). Patients attaining a complete response had a significantly longer duration of response compared with partial responders (median time 15.0 versus 11.5 months, respectively, p < 0.05). We conclude that intravenous clodronate (total dose 1500 mg) suppresses disease activity in the majority of patients with Paget disease of bone. The degree and duration of response were similar for the three regimens. Thus, in the treatment of Paget disease, the choice of regimen is a matter of convenience.
authors.affiliation: Department of Human Metabolism and Clinical Biochemistry, University of Sheffield Medical School, United Kingdom.
authors.forename: S A
authors.initials: SA
authors.lastname: Khan
authors.forename: E V
authors.initials: EV
authors.lastname: McCloskey
authors.forename: K S
authors.initials: KS
authors.lastname: Eyres
authors.forename: K
authors.initials: K
authors.lastname: Nakatsuka
authors.forename: P
authors.initials: P
authors.lastname: Sirtori
authors.forename: J
authors.initials: J
authors.lastname: Orgee
authors.forename: G
authors.initials: G
authors.lastname: Coombes
authors.forename: J A
authors.initials: JA
authors.lastname: Kanis
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D004002:Clodronic Acid / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D010001:Osteitis Deformans / Q000188:drug therapy*; D012189:Retrospective Studies
chemical_list: D004002:Clodronic Acid