title: [Treatment of Paget's disease with olpadronate. Its efficacy in partial responders to oral pamidronate].
abstract: Bisphosphonates are the treatment of choice in patients with Paget's disease. However in patients with an extensive disease it has been difficult to achieve complete biochemical remission. We studied the efficacy of the new bisphosphonate: olpadronate (dimethyl APD) in 37 patients (21 men and 16 women) with Paget's disease of (mean +/- 1SD) 68 +/- 8 years of age: Group I: 12 patients without previous specific treatment. Group II: 25 patients who had been treated before (time free of treatment before olpadronate: 11 +/- 8 months). (Table 1). Olpadronate was given orally in doses of 100 to 200 mg/day. Initial dose and/or increment of the dose during treatment were decided accordingly to the biochemical response. The length of therapy was (mean +/- 1SD) 3.5 +/- 2.4 months (range 0.5-13 months) and was adjusted to the changes produced upon the biochemical indexes of bone turnover. Olpadronate was well tolerated by all the patients except for one who discontinued the treatment due to gastrointestinal symptoms. Mean alkaline phosphatase (APh) decreased in both groups of patients as follows: Group I: basal: 36 +/- 20 KAU, final: 12 +/- 3 KAU (normal range: 5 to 15 KA units) and group II: basal 45 +/- 30 KAU final 14 +/- 10 KAU. (Table 2). Normalization of APh was observed in all patients of group I and in 21/25 patients of group II. Three patients of group II had partial responses (60% of diminution of APh without reaching normal values) and treatment was not effective in 1 patient. The length of remission was 8.7 +/- 5.7 months in group I and 10.4 +/- 8.1 months in group II. There was a significant inverse correlation between duration of remission and APh level post treatment. Fourteen patients of group II (7 women and 7 men) had previously received oral pamidronate (APD) in different cycles during a period of 6.6 +/- 4.2 years. After the first APD cycle, only 2 out of 14 achieved normal APh values and none of the 14 achieved complete biochemical remission after the last APD cycle. Olpadronate caused a significant decrease of serum APh and THP compared to the lowest values observed during APD treatment. Normalization of APh was observed in 12/14 of these partial responders to APD. (Table 3 and Figure 1). In conclusion, oral Olpadronate in a dose of 100 to 200 mg was well tolerated and effective in the treatment of Paget's disease even in those previous partial responders to APD.
authors.affiliation: Sección Osteopatías Médicas, Hospital de Clínicas José de San Martín, Universidad de Buenos Aires, Argentina.
authors.forename: D
authors.initials: D
authors.lastname: González
authors.forename: M
authors.initials: M
authors.lastname: Pastrana
authors.forename: C
authors.initials: C
authors.lastname: Mautalen
mesh_terms: D000368:Aged; D004164:Diphosphonates / Q000627:therapeutic use*; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D008297:Male; D010001:Osteitis Deformans / Q000188:drug therapy*; D000077268:Pamidronate; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D004164:Diphosphonates; C055774:olpadronic acid; D000077268:Pamidronate