Author/Editor     Kocijančič, Andreja; Preželj, Janez; Gantar-Rott, Urška; Kos-Golja, Mojca
Title     Intermitentno ciklično zdravljenje osteoporoze z etidronatom
Translated title     Intermittent cyclical etidronate treatment of osteoporosis
Type     članek
Source     Zdrav Vestn
Vol. and No.     Letnik 69, št. 2
Publication year     2000
Volume     str. 87-91
Language     slo
Abstract     Background. Etidronate has been used for the treatment of Paget's disease for s long time, its use in the treatment of osteoporosis is being reported more recently. The authors report on a randomized, double blind, placebo - controled clinical trial in which etidronate was used in 90 postmenopausal osteoporotic women. Methods. The patients were randomly assigned to a group taking 400 mg etidronate daily for two weeks, followed by 10 weeks with 1000 mg of calcium per day, and to a control group with the same regimen, where etidronate was replaced by placebo. The cycles were repeated every three months during one year. The effects were evaluated by measurement of bone mineral density (BMD) by dual energy x-ray absorptiometry (DEXA). X-ray was performed before and after the study to determine the vertebral fractures. Results. BMD significantly increased in the group treated with etidronate and calcium (5.0% +- 0.6; p<0.05), while in the placebo treated only with calcium the increase (2.5% +- 0.7) was not significant. In the treated group a marker of bone resorption, urinary hydroxyproline (adjusted for urinary creatinine) significantly decreased from 18.5 +- 1.1 micromol/mmol creatinine before therapy to 12.0 +-1.3 micromol/mmol creatinine after therapy. Serum osteocalcin, as a marker of bone formation, also significanty decreased from 19.1 nmol/L +- 1.5 to 11.8 nmol/L +- 1.2. No significant changes were detected in the control group. Number of x-ray detected vertebral fractures after one year increased in both groups with only differences between the treated and the placebo group. There were no serious side effects of the treatment during the study. Conclusion. Afer one year of treatment of osteoporosis in postmenopausal women with etidronate and calcium the BMD significantly increases.
Summary     Izhodišča. Avtorji so izvedli enoletno dvojno slepo s placebom nadzirano multicentrično klinično študijo na 90 bolnicah z osteoporozo, da bi preverili učinek etidronata v zdravljenju osteoporoze. Metode. Bolnice so bile naključno razdeljene v dve skupini, od katerih je ena prejemala ciklično intermitentno 400mg etidronata 14 dni in 10 tednov 1000mg kalcija, druga pa 14 dni placebo in 10 tednov kalcij v enakih odmerkih. Učinek etidronata smo ocenjevali glede na spremembe mineralne gostote kosti (BMD), merjene z dvojno energetsko absorpciometrijo (DEXA). Z rentgenskim slikanjem hrbtenice pred zdravljenjem in po njem smo ugotavljali število zlomov vretenc. Rezultati. BMD se je značilno (p<0.005) zvišala v skupini bolnic, zdravljenih 12 mesecev z etidronatom in kalcijem (5.0%+-0.6), v skupini bolnic, zdravljenih 12 s kalcijem, pa se bistveno ni spremenila (2.5%+-0.78). Kazalec resorpcije kosti (hidroksiprolin v urinu prerečunan na kreatinin) se je značilno znižal (18.5+-1.1 mikromol/mmol kreatina pred terapijo na 12.0+-1.3mikromol/mmol kreatina po terapiji), prav tako tudi kazalci tvorbe nove kosti (serumski osteokalcin z 19.1nmol/L +- 1.5 na 11.8 nmol/l +- 1.2) in alkalna fosfataza. Število zlommov vretenc se je v obeh skupinah zvišalo; med skupinama po številu novih zlomov ni bilo statistično pomembnih razlik. Pomemenbih stranskih pojavov med zdravljenjem nismo opazovali. Zaključek. Po enoletnem intermitentnim cikličnim zdravljenjem osteoporoze z etidronatom se BMD signifikantno zviša.
Descriptors     OSTEOPOROSIS
ETIDRONATE DISODIUM
CALCIUM
MIDDLE AGE
AGED
BONE DENSITY
SPINAL FRACTURES