Premium
Efficacy and tolerability of a new formulation of oral tiludronate (tablet) in the treatment of paget's disease of bone
Author(s) -
Reginster J.Y.,
Treves R.,
Renier J.C.,
Amor B.,
Sany J.,
Ethgen D.,
Picot C.,
Franchimont P.
Publication year - 1994
Publication title -
journal of bone and mineral research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.882
H-Index - 241
eISSN - 1523-4681
pISSN - 0884-0431
DOI - 10.1002/jbmr.5650090505
Subject(s) - medicine , tolerability , visual analogue scale , hydroxyproline , bone disease , paget's disease of bone , population , alkaline phosphatase , regimen , urology , gastroenterology , surgery , osteoporosis , disease , adverse effect , chemistry , biochemistry , environmental health , enzyme
We sought to assess efficacy and safety of a new oral formulation (tablet) of tiludronate in Paget's disease of bone. We studied 128 patients with Paget's disease in an open‐label uncontrolled trial. Patients received a daily dose of 400 mg oral tiludronate (two tablets). Treatment was for 6 months. Serum alkaline phosphatase activity (SAP) and fasting urinary excretion of hydroxyproline/creatinine (OH/Cr) were measured every 3 months, as were biochemical parameters reflecting renal, hepatic, and hematologic functions. Analgesic efficacy was self‐evaluated from a visual analog scale (VAS). Statistical analysis revealed a significant reduction from baseline in SAP and OH/Cr levels, as well as VAS scores. In the whole population with evaluation under treatment, there was a reduction in initial SAP activity after 3 months (47.2 ± 2.2%, mean ± SEM) and 6 months (58.3 ± 2.3%). In the population with SAP levels above twice the upper limit at inclusion and with evaluation at month 3 and month 6 ( n = 96), the reduction in SAP levels was 49.3 ± 2.4% after 3 months and of 59.5 ± 2.6% after 6 months (ANOVA time effect, p = 0.0001). Aside from mild gastrointestinal disturbances, as experienced with other oral bisphosphonates, clinical tolerance was good. Exhaustive biochemical investigation failed to reveal significant toxicity of tiludronate tablets at the dose of 400 mg/day. The dose of 400 mg daily of this new formulation appears to be a satisfactory tiludronate regimen for the treatment of Paget's disease of bone.