FrancophonIA/ELRC3.0 huggingface dataset:
English: CONBRIZA is only indicated for use in postmenopausal women (see section 4.3) and should not be used during breast-feeding.
Croatian: CONBRIZA je indicirana za korištenje samo u žena u postmenopauzi (vidjeti dio 4.3) i ne smije se koristiti tijekom dojenja.
English: The majority of adverse reactions occurring during the clinical trials were mild to moderate in severity and did not lead to discontinuation of therapy.
Croatian: Većina nuspojava koje su javile tijekom kliničkih ispitivanja bile su blagog do umjerenog intenziteta i nisu uzrokovale prekid terapije.
English: Table 1: Effect of bazedoxifene on risk of vertebral fractures after 3 years of treatment Number of subjects
Croatian: Tablica 1: Učinak bazedoksifena na rizik od prijeloma kralježaka nakon 3 godine liječenja Broj ispitanica
English: Bazedoxifene is eliminated with a half-life of approximately 30 hours.
Croatian: Bazedoksifen se eliminira uz poluvijek od približno 30 sati.
English: Talk to your doctor or pharmacist before taking CONBRIZA
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek CONBRIZA
English: c p-value=0.22
Croatian: c p-vrijednost = 0,22
English: This pharmacological effect of bazedoxifene can also be expected in pre-menopausal women, but is considered clinically irrelevant in post-menopausal women.
Croatian: Ovakav farmakološki učinak bazedoksifena može se očekivati i u predmenopauzalnih žena, no ne smatra se važnim za kliničku primjenu u žena u postmenopauzi.
English: The risk factors associated with VTE cases in clinical trials included: advanced age, obesity, immobilisation, surgery, major trauma and malignancy.
Croatian: Rizični čimbenici povezani sa slučajevima VTE-a u kliničkim ispitivanjima uključivali su: stariju dob, pretilost, imobilizaciju, kirurški zahvat, veliku traumu i malignu bolest.
English: This increase was most likely attributed to age-related changes in hepatic function.
Croatian: Taj se porast najvjerojatnije može pripisati dobno uvjetovanim promjenama jetrene funkcije.
English: Therecommendeddose is one tablet by mouth daily.Taking more than one tablet daily is not more effective and may carry additional risks.
Croatian: Uzimanje više od jedne tablete na dan nije učinkovitije, a može donijeti dodatne rizike.
English: The underlying nature of these events is uncertain.
Croatian: Nije poznata podloga tih događaja.
English: If you are traveling on long trips, you should walk around or exercise your legs and feet at regular intervals.
Croatian: Na dugim putovanjima se trebate ustajati i hodati ili redovito razgibavati noge i stopala.
English: If you need to remain immobile for an extended period of time or are scheduled to have surgery, it is important for you to talk to your doctor about ways you can reduce the risk of blood clots.
Croatian: Morate li dulje vrijeme mirovati ili planirate ići na operaciju, važno je da sa svojim liječnikom porazgovarate o tome kako možete umanjiti rizik od krvnih ugrušaka. ako niste u menopauzi.
English: Each film-coated tablet contains 142.8 mg lactose (as monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 142,8 mg laktoze (kao hidrata).
English: Hypromellose Titanium dioxide (E171) Macrogol 400
Croatian: Film ovojnica: hipromeloza titanijev dioksid (E171) makrogol 400
English: CONBRIZA should be discontinued prior to and during prolonged immobilisation (e.g., post-surgical recovery, prolonged bed rest), and therapy should be resumed only after the patient is fully ambulatory.
Croatian: Nužno je prekinuti primjenu lijeka CONBRIZA prije i tijekom dugotrajne imobilizacije (npr. tijekom oporavka nakon operacije ili dugotrajnog ležanja), a terapiju treba nastaviti tek nakon što je bolesnica u potpunosti pokretna.
English: The concentrations of this glucuronide are approximately 10-fold higher than those of unchanged active substance in plasma.
Croatian: Koncentracije tog glukuronida u plazmi su približno 10 puta veće od koncentracija nepromijenjene djelatne tvari.
English: These tumours are considered as spontaneous renal cell carcinomas that are known to occur in nonhuman primates and are unlikely to be relevant to humans.
Croatian: Ti se tumori smatraju spontanim karcinomima bubrežnih stanica koji su poznati u nečovjekolikih primata i nije vjerojatno da su relevantni za ljude.
English: The safety data in the following table are derived from both clinical trials and spontaneous post-marketing reporting.
Croatian: Sigurnosni profil u sljedećoj tablici dobiven je iz kliničkih ispitivanja i spontanim prijavljivanjem nakon stavljanja lijeka u promet.
English: The bazedoxifene 40 mg dose was decreased to a 20 mg dose after approximately 4 years.
Croatian: Doza bazedoksifena od 40 mg smanjena je na 20 mg nakon približno 4 godine.
English: No dose adjustment is necessary based on age.
Croatian: Nije potrebno prilagođavati dozu s obzirom na dob.
English: The median T-score ranged from -0.6 to -1.4, depending on the skeletal site.
Croatian: Medijan T-vrijednosti kretao se između -0,6 i -1,4, ovisno o dijelu skeleta.
English: What you need to know before you take CONBRIZA
Croatian: Što morate znati prije nego počnete uzimati lijek CONBRIZA
English: EU/1/09/511/001 28 tablets EU/1/09/511/002 30 tablets EU/1/09/511/003 84 tablets EU/1/09/511/004 90 tablets EU/1/09/511/005 7 tablets
Croatian: EU/1/09/511/001 (28 tableta) EU/1/09/511/002 (30 tableta) EU/1/09/511/003 (84 tablete) EU/1/09/511/004 (90 tableta) EU/1/09/511/005 (7 tableta)
English: A significant reduction in the incidence of vertebral fractures has been demonstrated; efficacy on hip fractures has not been established.
Croatian: Dokazano je značajno smanjenje incidencije prijeloma kralježaka, no nije utvrđena djelotvornost u prijelomima kuka.
English: Since chronic progressive nephropathy and corticomedullar nephrocalcinosis are most likely rat-specific nephropathies, these findings are presumably not relevant for humans.
Croatian: S obzirom da su kronična progresivna nefropatija i kortikomedularna nefrokalcinoza najvjerojatnije nefropatije specifične za štakore, pretpostavlja se da ovi nalazi nisu relevantni za ljude.
English: Because these changes are not considered clinically relevant, bazedoxifene can be administered without regard to meals.
Croatian: S obzirom da se te promjene ne smatraju statistički značajnima, bazedoksifen se može primjenjivati neovisno o obroku.
English: No data are available on the concomitant use with agents used in the treatment of early or advanced breast cancer.
Croatian: Nema podataka o istodobnoj primjeni s lijekovima koji se koriste u liječenju ranog ili uznapredovalog raka dojke.
English: The 3-year core study was extended twice, with two 2-year double-blind, placebocontrolled extensions, resulting in a total treatment duration of up to 7 years (7-year study).
Croatian: Trogodišnje osnovno ispitivanje produljeno je dva puta sa dva dvogodišnja dvostruko slijepa, placebom kontrolirana nastavka ispitivanja, čime ukupno trajanje liječenja iznosi 7 godina (sedmogodišnje ispitivanje).
English: The rate of VTE was highest in the first year with a relative risk of 2.69.
Croatian: Stopa VTE-a bila je najveća u prvoj godini, uz relativan rizik od 2,69.
English: a of subjects with ≥1 new vertebral fracture Kaplan-Meier rate estimates p-value=0.015
Croatian: a ispitanica s ≥ 1 novim prijelomom kralješka Kaplan-Meierove procjene stopa p-vrijednost = 0,015
English: Vision disorders/Ocular events
Croatian: Poremećaji vida/Okularni događaji
English: All subjects received calcium supplementation daily; most received 600 mg calcium (e.g., Caltrate) daily, while some received up to 1,200 mg daily.
Croatian: Sve su ispitanice dnevno uzimale nadomjeske kalcija; većina ih je primala 600 mg kalcija na dan (npr. Caltrate), a neke su uzimale do 1200 mg na dan.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenimažuriranim verzijama RMP-a .
English: Following intravenous administration of a 3 mg dose of bazedoxifene, the volume of distribution is 14.7 ± 3.9 l/kg.
Croatian: Nakon intravenske primjene doze bazedoksifena od 3 mg volumen distribucije iznosi 14,7 ± 3,9 l/kg.
English: The treatment effect was similar among those with and without prevalent vertebral fractures (Table 1).
Croatian: Učinak liječenja bio je sličan u bolesnica koje su imale prethodne prijelome i onih koje ih nisu imale (Tablica 1).
English: In clinical trials, somnolence was reported as an adverse reaction, and patients should be advised on the potential effect on driving and using machines.
Croatian: U kliničkim je ispitivanjima somnolencija prijavljena kao nuspojava te je bolesnice potrebno upozoriti na mogući učinak na upravljanje vozilima i rad na strojevima.
English: If this happens, you should avoid driving or operating machines until your doctor tells you that it is safe to do so.
Croatian: Ako se to dogodi, morate izbjegavati vožnju i rukovanje strojevima dok Vam liječnik ne kaže da tomožete činiti.
English: All subjects were to receive 1,200 mg of elemental calcium and 400 IU of vitamin D daily.
Croatian: Sve su ispitanice morale uzimati 1200 mg elementarnog kalcija i 400 IU vitamina
English: The efficacy of bazedoxifene was established in two multicentre, double-blind, randomised, placeboand active-control, Phase 3 trials: 3-year osteoporosis treatment trial and a 2-year osteoporosis prevention trial.
Croatian: Djelotvornost bazedoksifena utvrđena je u dva multicentrična, dvostruko slijepa, randomizirana, placebom i aktivnim lijekom kontrolirana ispitivanja faze III: trogodišnjem ispitivanju liječenja osteoporoze i dvogodišnjem ispitivanju prevencije osteoporoze.
English: Blood triglycerides increased, alanine aminotransferase increased, aspartate aminotransferase increased.
Croatian: Pretrage povišene razine triglicerida u krvi, povišene razine alanin aminotransferaz e; povišene razine aspartat aminotransferaz
English: Bazedoxifene is highly bound (98% - 99%) to plasma proteins in vitro.
Croatian: Bazedoksifen se in vitro u velikom opsegu (98% - 99%) veže za proteine u plazmi.
English: In addition, women taking CONBRIZA should be advised to move about periodically during prolonged travel.
Croatian: Osim toga, ženama koje uzimaju lijek CONBRIZA treba savjetovati da tijekom duljeg putovanja povremeno ustanu i hodaju.
English: Mean ± SD pharmacokinetic parameters of bazedoxifene (n=23) Cmax (ng/ml)
Croatian: Tablica 2: Srednja vrijednost ± SD farmakokinetičkih parametara bazedoksifena (n=23) Cmax (ng/ml)
English: The treatment effect on lipids was similar in the osteoporosis prevention study.
Croatian: Učinak liječenja na lipide bio je sličan i u ispitivanju prevencije osteoporoze.
English: If you take supplemental calcium and/or vitamin D, it may be taken at the same time as this medicine.
Croatian: Uzimate li nadomjeske kalcija i vitaminaD, možete ih uzimati istodobno kada i lijek.
English: It is used for the treatment of osteoporosis in women after they have reached menopause, when they are at an increased risk of fractures.
Croatian: Koristi se za liječenje osteoporoze u žena nakon menopauze, kada im je povećan rizik od prijeloma.
English: Histological assessment of bone biopsies from all treatment groups revealed formation of normal lamellar bone in all treated subjects.
Croatian: Histološka procjena uzoraka dobivenih biopsijom u svim terapijskim skupinama otkrila je stvaranje normalne lamelarne kosti u svih liječenih ispitanica.
English: Osteoporosis prevention trial
Croatian: Ispitivanje prevencije osteoporoze
English: Patients with signs or symptoms of endometrial cancer; safety in this patient group has not been adequately studied.
Croatian: Bolesnice sa znakovima ili simptomima raka endometrija jer nije dovoljno ispitana sigurnost primjene u toj skupini bolesnica.
English: Limited clinical data (n=5) are available in subjects with moderate renal impairment (CrCl  50 ml/min).
Croatian: Malo je kliničkih podataka (n=5) o ispitanicama s umjerenim oštećenjem bubrega (CrCl  50 ml/min).
English: There were no significant pharmacokinetic interactions between bazedoxifene and the following medicinal products: ibuprofen, atorvastatin, azithromycin, or an antacid containing aluminium and magnesium hydroxide.
Croatian: Nisu zabilježene značajne farmakokinetičke interakcije između bazedoksifena i sljedećih lijekova: ibuprofena, atorvastatina, azitromicina ili antacida koji sadrže aluminij i magnezijev hidroksid.
English: Tell your doctor or pharmacist if you accidentally take more CONBRIZA than you should.
Croatian: Obavijestite svog liječnika ili ljekarnika, ako zabunom uzmete više lijeka CONBRIZA nego što ste trebali.
English: If you have other events affecting the eye and/or vision (seeing sparks or flashes of light, narrowing of visual field, and swelling of eye or eyelid)
Croatian: Ako imate druge događaje koje zahvaćaju oko i/ili vid (iskrenje ili bljeskanje svjetla, sužavanje vidnog polja, i oticanje oka ili očnog kapka)
English: Bazedoxifene has not been studied in women with triglyceride levels 300 mg/dl (3.4 mmol/litre).
Croatian: Bazedoksifen nije ispitivan u žena čije su razine triglicerida > 300 mg/dl (> 3,4 mmol/l).
English: Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.
Croatian: Nositelj odobrenja: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgija.
English: They are packed in PVC/Aclar blisters and are available in packs of 7, 28, 30, 84 or 90 tablets.
Croatian: Tablete su pakirane u PVC/Aclar blistere, a dostupne veličine pakiranja su 7, 28, 30, 84 ili 90 tableta.
English: Discontinuation from the study was required when excessive bone loss or incident vertebral fractures occurred.
Croatian: Ispitanice su isključivane iz ispitivanja u slučaju prekomjernog koštanog gubitka ili slučajnih prijeloma kralježaka.
English: You should continue taking this medicine as long as your doctor tells you to.
Croatian: Morate uzimati ovaj lijek sve dok Vam to preporučuje liječnik.
English: CONBRIZA is associated with an increased risk of venous thromboembolism (VTE).
Croatian: CONBRIZA je povezana s povećanim rizikom za venske tromboembolije (VTE).
English: The raloxifene group was discontinued during the first 2-year extension.
Croatian: Skupina koja je primala raloksifen nije nastavila ispitivanje u prvom dvogodišnjem nastavku.
English: Latvijā Pfizer Luxembourg SARL filiāle Latvijā
Croatian: Pfizer Luxembourg SARL filialas Lietuvoje
English: Its safety in premenopausal women has not been established, and its use is not recommended in this population.
Croatian: Nije ustanovljena sigurnost primjene ovog lijeka u predmenopauzalnih žena te se njegova primjena ne preporučuje u ovoj populaciji.
English: PVC/Aclar blister packs of 7, 28, 30, 84, and 90 film-coated tablets.
Croatian: PVC/Aclar blisteri sa 7, 28, 30, 84 i 90 filmom obloženih tableta.
English: Studies in rabbits have shown reproductive toxicity (see section 5.3).
Croatian: Istraživanja na kunićima pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
English: Studies in rats have shown adverse effects on fertility (see section 5.3).
Croatian: Istraživanja na štakorima pokazala su štetne učinke na plodnost (vidjeti dio 5.3).
English: Bazedoxifene undergoes metabolism by uridine diphosphate glucuronosyltransferase (UGT) enzymes in the intestinal tract and liver (see section 5.2).
Croatian: Bazedoksifen se metabolizira putem enzima uridindifosfat glukuronoziltransferaze (UGT) u probavnom traktu i jetri (vidjeti dio 5.2).
English: In rats, treatment with bazedoxifene for approximately one year partially prevented the effects of ovariectomy on numerous skeletal parameters (bone mineral content, bone mineral density, and architecture).
Croatian: U štakorica je liječenje bazedoksifenom tijekom približno godine dana djelomično spriječilo učinke ovarijektomije na brojne koštane parametre (mineralni sadržaj kostiju, mineralnu gustoću kostiju i arhitektoniku).
English: In subjects with 10-year fracture probabilities at or above 16%, bazedoxifene was associated with a significant decrease in the risk of all clinical fractures.
Croatian: U ispitanica čija je 10-godišnja vjerojatnost prijeloma bila jednaka ili veća od 16%, primjena bazedoksifena bila je povezana sa značajnim smanjenjem rizika za sve kliničke prijelome.
English: If any of them apply to you, talk to your doctor before you take the medicine.
Croatian: Ako se nešto od navedenog odnosi na Vas, obratite se svom liječniku prije nego uzmete ovaj lijek.
English: The effect of bazedoxifene on BMD at other skeletal sites was similar.
Croatian: Sličan je bio učinak bazedoksifena na BMD na drugim dijelovima skeleta.
English: The metabolism of bazedoxifene may be increased by concomitant use of substances known to induce UGTs, such as rifampicin, phenobarbital, carbamazepine, and phenytoin, potentially leading to decreased systemic concentrations of bazedoxifene.
Croatian: Metabolizam bazedoksifena može se povećati uz istovremenu primjenu tvari za koje se zna da induciraju UGT, kao što su rifampicin, fenobarbital, karbamazepin i fenitoin, što potencijalno dovodi do smanjene sistemske koncentracije bazedoksifena.
English: The mean 10-year fracture probability of a major osteoporotic fracture for the entire study population was 11%.
Croatian: Prosječna 10-godišnja vjerojatnost za veliki prijelom zbog osteoporoze iznosila je 11% za cijelu populaciju uključenu u ispitivanje.
English: In long-term studies renal tumours (adenomas and carcinomas) were observed at all doses tested, most likely as a consequence of this chronic renal damage.
Croatian: U dugotrajnim ispitivanjima pri svim su ispitivanim dozama opaženi tumori bubrega (adenomi i karcinomi), koji su najvjerojatnije bili posljedica tog kroničnog oštećenja bubrežne funkcije.
English: Do not take CONBRIZA
Croatian: Nemojte uzimati lijek CONBRIZA
English: Importantly, in both species, the administration of bazedoxifene had no deleterious effects on bone quality.
Croatian: Važno je da niti u jednoj od te dvije vrste primjena bazedoksifena nije štetno djelovala na kvalitetu kosti.
English: Impaired renal function showed little or no influence on bazedoxifene pharmacokinetics, and no dosing adjustment is required.
Croatian: Poremećaj bubrežne funkcije ima malen ili nikakav utjecaj na farmakokinetiku bazedoksifena te nije potrebno prilagođavati dozu.
English: Race No pharmacokinetic differences based on ethnic group were observed.
Croatian: Rasa Nisu opažene razlike u farmakokinetici s obzirom na etničko podrijetlo.
English: The safety of CONBRIZA in patients with breast cancer has not been studied.
Croatian: Sigurnost lijeka CONBRIZA u bolesnica s rakom dojke nije ispitana.
English: There are no data from the use of bazedoxifene in pregnant women.
Croatian: Nema podataka o primjeni bazedoksifena u trudnica.
English: If you stop taking CONBRIZA
Croatian: Ako prestanete uzimati lijek CONBRIZA
English: If you forget to take CONBRIZA
Croatian: Ako ste zaboravili uzeti lijek CONBRIZA
English: The increases in BMD relative to placebo remained statistically significant at all skeletal sites throughout the 5 years of treatment with bazedoxifene.
Croatian: Porast BMD-a u odnosu na placebo ostao je statistički značajan na svim dijelovima skeleta tijekom petogodišnjeg liječenja bazedoksifenom.
English: Based on in vitro bazedoxifene plasma protein binding characteristics, drug interactions with warfarin, digoxin and diazepam are unlikely.
Croatian: Sudeći prema obilježjima vezanja bazedoksifena za proteine u plazmi in vitro nisu vjerojatne interakcije s varfarinom, digoksinom i diazepamom.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza "Rok valjanosti ili EXP".
English: These effects on bone remodeling lead to an increase in bone mineral density (BMD), which in turn contributes to a reduction in the risk of fractures.
Croatian: Ti učinci na remodeliranje kosti dovode do povećanja mineralne gustoće kostiju (engl. bone mineral density, BMD), što pridonosi smanjenju rizika od prijeloma.
English: If you have signs of a blood clot in the legs or lungs, such as painful swelling and redness of the legs, sudden chest pain, or difficulty in breathing;
Croatian: Ako se pojave znakovi krvnog ugruška u nogama ili plućima, poput bolnog oticanja i crvenila nogu, iznenadne boli u prsima ili otežanog disanja.
English: If you have any further questions on the use or stopping the use of this medicine, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ili prestankom primjene ovog lijeka, obratite se svom liječniku ili ljekarniku.
English: if you are immobile (unable to move) for some time, such as being wheel-chair bound, sitting for a prolonged period of timeor having to stay in bed while recovering from an operation or illness.
Croatian: ako ste dulje vrijeme nepokretni (ne možete hodati), primjerice ako ste vezani za invalidska kolica, dugotrajno sjedite ili ležite dokse oporavljate od operacije ili bolesti.
English: Patients may experience visual symptoms such as visual acuity disturbance or blurred vision.
Croatian: Bolesnice mogu imati vizualne simptome poput poremećaja oštrine vida ili zamagljenog vida.
English: if you have any unexplained vaginal bleeding.
Croatian: ako imate nerazjašnjeno krvarenje iz rodnice.
English: Urine parameters were pathologically changed.
Croatian: Zabilježene su patološke promjene parametara mokraće.
English: Bazedoxifene does not induce or inhibit the activities of major CYP isoenzymes.
Croatian: Bazedoksifen ne inducira niti inhibira djelovanje glavnih CYP izoenzima.
English: This includes any possible side effects not listed in this leaflet.See section4.
Croatian: To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.Pogledajtedio 4.
English: There was no evidence of osteomalacia, peritrabecular or marrow fibrosis, cellular toxicity or woven bone in any of the bone-biopsy specimens in any of the treatment groups.
Croatian: Nije bilo znakova osteomalacije, peritrabekularne fibroze ili fibroze koštane srži, stanične toksičnosti ni vlaknaste kosti niti u jednom uzorku biopsije kosti, svih terapijskih skupina.
English: When determining the choice of CONBRIZA or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Croatian: Kada se za pojedinu ženu u postmenopauzi razmatra odabir lijeka CONBRIZA ili drugih lijekova, uključujući estrogene, treba uzeti u obzir simptome menopauze, učinke na tkivo maternice i dojki te rizike i koristi za srce i krvne žile (vidjeti dio 5.1).
English: Histomorphometric assessment revealed normal mineralisation, as evidenced by the presence of normal osteoid thickness, normal mineralisation lag time, and mineral apposition rate.
Croatian: Histomorfometrijska procjena otkrila je normalnu mineralizaciju na koju su ukazivali normalna debljina osteoida, normalno vrijeme između stvaranja i naknadne mineralizacije osteoida i brzina odlaganja minerala.
English: Osteoporosis treatment trial
Croatian: Ispitivanje liječenja osteoporoze
English: Use of CONBRIZA is not recommended in women at an increased risk for venous thromboembolic events.
Croatian: Ne preporučuje se primjena lijeka CONBRIZA u žena s povećanim rizikom za venske tromboembolijske događaje.
English: In monkeys, treatment with bazedoxifene for 18 months resulted in the partial preservation of cortical and cancellous bone mass as determined by BMD measurements.
Croatian: U majmunica je liječenje bazedoksifenom tijekom 18 mjeseci dovelo do djelomičnog očuvanja kortikalne i spongiozne koštane mase, kako je utvrđeno mjerenjem BMD-a.