FrancophonIA/ELRC3.0 huggingface dataset:
English: The absorbed fraction of ibandronic acid is removed from the circulation via bone absorption (estimated to be 40-50%) and the remainder is eliminated unchanged by the kidney.
Croatian: Apsorbirana frakcija ibandronatne kiseline se iz cirkulacije uklanja putem koštane apsorpcije (procijenjeno na 40-50%), a ostatak se nepromijenjen izlučuje putem bubrega.
English: The deterioration in Quality of Life and WHO performance status was significantly less in ibandronic acid treated patients compared with placebo.
Croatian: Pogoršanje kvalitete života i općeg stanja prema WHO, bilo je znatno manje u bolesnika liječenih ibandronatnom kiselinom nego u bolesnika koji su primali placebo.
English: The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, and ocular inflammation (see paragraph “Description of selected adverse reactions” and section 4.4).
Croatian: Najozbiljnije prijavljene nuspojave su anafilaktička reakcija/šok, atipični prijelomi bedrene kosti, osteonekroza čeljusti, gastrointestinalna iritacija i upala oka (vidjeti odlomak „Opis odabranih nuspojava“ i dio 4.4).
English: - radiotherapy to bone for treatment of fractures/impending fractures, - surgery to bone for treatment of fractures, - vertebral fractures, - non-vertebral fractures.
Croatian: - radioterapija kostiju radi liječenja prijeloma/mogućih prijeloma, - operacija kostiju zbog liječenja prijeloma, - prijelomi kralježnice, - drugi prijelomi osim kralježnice.
English: Osteonecrosis of the external auditory canal
Croatian: Osteonekroza vanjskog slušnog kanala
English: The risk of severe oesophageal adverse experiences appears to be greater in patients who do not comply with the dosing instruction and/or who continue to take oral bisphosphonates after developing symptoms suggestive of oesophageal irritation.
Croatian: Rizik od teških štetnih događaja jednjaka čini se veći u bolesnika koji se ne pridržavaju uputa o doziranju i/ili koji nastavljaju peroralno primjenjivati bisfosfonate nakon pojave simptoma koji upućuju na iritaciju jednjaka.
English: No dose adjustment is required (see section 5.2).
Croatian: Nije potrebna prilagodba doze (vidjeti dio 5.2).
English: In humans, the apparent terminal volume of distribution is at least 90 l and the amount of dose reaching the bone is estimated to be 40-50% of the circulating dose.
Croatian: U ljudi, prividni terminalni volumen distribucije iznosi najmanje 90 l, dok se količina doze koja dospijeva do kosti procjenjuje na 40-50% cirkulirajuće doze.
English: - Supplements containing calcium, magnesium, iron or aluminium, as they could possibly influence the effects of Ibandronic Acid Teva.
Croatian: ˗ dodatke koji sadrže kalcij, magnezij, željezo ili aluminij jer mogu utjecati na učinke Ibandronatne kiseline Teva.
English: Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% and 18% of patients used histamine (H2) blockers or proton pump inhibitors after one and two years, respectively.
Croatian: 14% od više od 1500 bolesnika uključenih u ispitivanje BM 16549 u kojem su se uspoređivali mjesečni i dnevni režimi doziranja ibandronatne kiseline nakon jedne godine koristilo je histaminske (H2) blokatore ili inhibitore protonske pumpe, odnosno 18% nakon dvije godine.
English: A clinically meaningful reduction of 50 % of biochemical markers of bone resorption was observed as early as one month after start of treatment with ibandronic acid 2.5 mg.
Croatian: Klinički značajno smanjenje biokemijskih biljega koštane resorpcije od 50 % primijećeno je već mjesec dana nakon početka liječenja ibandronatnom kiselinom u dozi od 2,5 mg.
English: You can drive and use machines as it's expected that Ibandronic Acid Teva has no or negligible effect on your ability to drive and use machines.
Croatian: Možete upravljati vozilima i strojevima jer se očekuje da Ibandronatna kiselina Teva ne utječe ili zanemarivo utječe na Vašu sposobnost upravljanja vozilima i strojevima.
English: In some cases, these events did not resolve until the ibandronic acid was discontinued.
Croatian: U nekim slučajevima ovi simptomi se nisu povukli sve do prekida primjene ibandronatne kiseline.
English: Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Croatian: Osteonekroza vanjskog slušnog kanala prijavljena je s bisfosfonatima, uglavnom povezana s dugoročnom terapijom.
English: Patients with a previous history of gastrointestinal disease including patients with peptic ulcer without recent bleeding or hospitalisation, and patients with dyspepsia or reflux controlled by medication were included in the once monthly treatment study.
Croatian: Bolesnici koji su imali gastrointestinalne bolesti u anamnezi, uključujući bolesnike s peptičkim ulkusom u kojih nije došlo do nedavnog krvarenja ili hospitalizacije te bolesnike s dispepsijom ili refluksom koji je kontroliran lijekovima, uključeni su u ispitivanje primjene mjesečne doze.
English: SMPR (per patient year)
Croatian: SMPR (po bolesnik-godini)
English: Hypersensitivi ty†, bronchospasm angioedema†, anaphylactic reaction/shock
Croatian: Preosjetljivost† bronhospazam† angioedem†, anafilaktička reakcija/šok†*
English: Also some other medicines can affect the way Ibandronic Acid Teva works.
Croatian: Također, drugi lijekovi mogu utjecati na djelovanje Ibandronatne kiseline Teva.
English: Ibandronic acid belongs to the bisphosphonate group of compounds which act specifically on bone.
Croatian: Ibandronatna kiselina pripada u skupinu bisfosfonata, tvari koji djeluju specifično na kosti.
English: Marketing Authorisation Holder: Teva B.V.
Croatian: Nositelj odobrenja za stavljanje u promet lijeka: Teva B.V.
English: Influenza-like illness includes events reported as acute phase reaction or symptoms including myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, or bone pain.
Croatian: Bolest slična gripi uključuje događaje prijavljene kao reakcija akutne faze ili simptome koji uključuju bol u mišićima, bol u zglobovima, vrućicu, zimicu, umor, mučninu, gubitak apetita ili bol u kostima.
English: Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of water and/or if you lie down within an hour of taking Ibandronic Acid Teva.
Croatian: Mogu se javiti iritacija, upala ili vrijed jednjaka/cijevi koja povezuje usta sa želucem (ezofagus), često sa simptomima jake boli u prsima, jake boli nakon gutanja hrane i/ili pića, jake mučnine ili povraćanja, osobito ako ne popijete punu čašu vode i/ili ako legnete unutar jednog sata nakon uzimanja lijeka Ibandronatna kiselina Teva.
English: The recommended dose is one 150 mg film-coated tablet once a month.
Croatian: Preporučena doza je jedna filmom obložena tableta od 150 mg jedanput mjesečno.
English: Tests for genotoxicity revealed no evidence of genetic activity for ibandronic acid.
Croatian: U testovima genotoksičnosti nije bilo dokaza genetske aktivnosti ibandronatne kiseline.
English: Both bioavailability and BMD gains are reduced when food or beverage is taken less than 60 minutes after ibandronic acid is ingested.
Croatian: Bioraspoloživost i povećanje BMD smanjuju se ako se hrana ili piće uzimaju prije nego prođe 60 minuta od primjene ibandronatne kiseline.
English: Ibandronic Acid Teva may help lower the chances of breaking bones (fractures).
Croatian: Ibandronatna kiselina Teva može smanjiti rizik za prijelom kostiju (fraktura).
English: No dose adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Croatian: Prilagodba doze nije potrebna u bolesnika s blagim oštećenjem bubrega (CLcr ≥50 i <80 ml/min).
English: Toxic effects, e.g signs of renal damage, were observed in dogs only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Croatian: Toksični učinci, npr. znakovi oštećenja bubrega, zamijećeni su u pasa samo pri izloženosti dozama koje se smatraju znatno višima od maksimalno dopuštenih kod ljudi, što upućuje na malu važnost za kliničku primjenu.
English: Decreased renal calcium excretion may be accompanied by a fall in serum phosphate levels not requiring therapeutic measures.
Croatian: Smanjeno izlučivanje kalcija putem bubrega može biti praćeno padom razine fosfata u krvi, što ne zahtjeva terapijske mjere.
English: • severe adverse skin reactions
Croatian: • teške kožne nuspojave
English: Based on the results of study BM 16549, ibandronic acid 150 mg once monthly is expected to be at least as effective in preventing fractures as ibandronic acid 2.5 mg daily.
Croatian: Na temelju rezultata studije BM 16549 očekuje se da će ibandronatna kiselina 150 mg jedanput mjesečno biti barem jednako djelotvorna u sprječavanju prijeloma kao ibandronatna kiselina 2,5 mg jedanput dnevno.
English: On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that Ibandronic Acid Teva has no or negligible influence on the ability to drive and use machines.
Croatian: S obzirom na farmakodinamički i farmakokinetički profil lijeka i prijavljene nuspojave, očekuje se da Ibandronatna kiselina Teva ne utječe ili zanemarivo utječe na sposobnost upravljanja motornim vozilima i rada na strojevima.
English: Do not make yourself vomit, and do not lie down - this could cause Ibandronic Acid Teva to irritate your oesophagus.
Croatian: Nemojte izazivati povraćanje i nemojte leći jer bi Ibandronatna kiselina Teva mogla nadražiti jednjak.
English: Studies in rats have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja u štakora pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
English: Ibandronic Acid Teva should be taken after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than water) of the day (see section 4.5) or any other oral medicinal products or supplementation (including calcium).
Croatian: Ibandronatnu kiselinu Teva treba uzeti nakon noćnog gladovanja (barem 6 sati) i 1 sat prije uzimanja prve hrane ili pića (osim obične vode) na početku dana (vidjeti dio 4.5) te drugih oralnih lijekova ili nadomjesnih preparata (uključujući kalcij).
English: Opadry white YS-1-7003: Titanium dioxide (E 171) Hypromellose Macrogol 400
Croatian: Opadry white YS-1-7003 titanijev dioksid (E 171) hipromeloza makrogol 400 polisorbat 80
English: Medicinal product-Food Interaction
Croatian: Interakcije lijek - hrana
English: Bioavailability was reduced by approximately 75% when ibandronic acid tablets were administered 2 hours after a standard meal.
Croatian: Bioraspoloživost se smanjuje za otprilike 75% ako se tablete ibandronatne kiseline uzimaju 2 sata nakon standardnog obroka.
English: In addition, ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and does not induce the hepatic cytochrome P450 system in rats.
Croatian: Osim toga, ibandronatna kiselina ne inhibira glavne izoenzime citokroma P450 u ljudskoj jetri i ne inducira jetreni P450 citokromski sustav u štakora.
English: There is no relevant use of Ibandronic Acid Teva in children below 18 years, and Ibandronic Acid Teva was not studied in this population (see section 5.1 and section 5.2).
Croatian: Ibandronatna kiselina Teva nije bila značajno primjenjivana u djece mlađe od 18 godina pa nije ispitivana u ovoj populaciji (vidjeti dijelove 5.1 i 5.2).
English: Clinical studies in patients with breast cancer and bone metastases have shown that there is a dose dependent inhibitory effect on bone osteolysis, expressed by markers of bone resorption, and a dose dependent effect on skeletal events.
Croatian: Klinička ispitivanja u bolesnika s rakom dojke i koštanim metastazama pokazala su da postoji inhibitorni učinak na osteolizu kostiju ovisan o dozi, izražen biljezima resorpcije kostiju, te učinak na koštane promjene ovisan o dozi.
English: Incidence of clinical vertebral fracture 6.97 % (4.67, 9.27) BMD - mean change relative to baseline lumbar spine at year 3
Croatian: Incidencija kliničkih prijeloma kralježaka 6,97% (4,67; 9,27) 3,57% (1,89; 5,24) BMD - srednja promjena u odnosu na početne vrijednosti za lumbalnu kralježnicu nakon 3 godine
English: It's important to keep taking Ibandronic Acid Teva every month, as long as your doctor prescribes it for you.
Croatian: Nastavljanje uzimanja lijeka Ibandronatna kiselina Teva Važno je uzimati Ibandronatnu kiselinu Teva svaki mjesec, dok god Vam to propisuje Vaš liječnik.
English: Due to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Croatian: Zbog opasnosti od iritacije jednjaka ne smije se izazivati povraćanje, a bolesnik mora cijelo vrijeme ostati u uspravnom položaju.
English: * Mean change from baseline to last assessment.
Croatian: * Srednja vrijednost promjene od početne vrijednosti do zadnje procjene.
English: The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration and plasma concentrations increase in a dose-proportional manner up to 50 mg oral intake, with greater than dose-proportional increases seen above this dose.
Croatian: Apsorpcija ibandronatne kiseline u gornjem dijelu probavne cijevi vrlo je brza nakon peroralne primjene, dok se koncentracija u plazmi povećava proporcionalno dozi sve do peroralne primjene 50 mg, a pri većim dozama zamijećeno je povećanje veće od onog proporcionalnog dozi.
English: Physicians should be alert to any signs or symptoms signaling a possible oesophageal reaction and patients should be instructed to discontinue Ibandronic Acid Teva and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
Croatian: Liječnici trebaju biti oprezni prilikom pojave bilo kojeg znaka ili simptoma koji upućuje na moguću reakciju jednjaka, a bolesnici trebaju biti upućeni da prestanu uzimati Ibandronatnu kiselinu Teva i potraže liječničku pomoć ako se pojavi disfagija, odinofagija, retrosternalna bol, žgaravica ili dođe do pogoršanja žgaravice.
English: - If you have any further questions, ask your doctor or pharmacist.
Croatian: • Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku
English: Other medicines and Ibandronic Acid Teva
Croatian: Drugi lijekovi i Ibandronatna kiselina Teva
English: • new pain, weakness or discomfort in your thigh, hip or groin.
Croatian: • novonastala bol, slabost ili nelagoda u bedru, kuku ili preponama.
English: Pooled data from these studies demonstrated a significant advantage for ibandronic acid 50 mg p.o. over placebo in the reduction in SREs measured by the SMPR (p=0.041).
Croatian: Podaci prikupljeni tijekom ovog ispitivanja pokazali su znatnu prednost ibandronatne kiseline 50 mg peroralno u odnosu na placebo u pogledu smanjivanja SRE, mjereno SMPR-om (p=0,041).
English: Talk to your doctor or pharmacist before taking Ibandronic Acid Teva: - if you are allergic to any other bisphosphonates - if you have any swallowing or digestion problems - if you have high or low blood levels of vitamin D or any other minerals - if you have kidney problems.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Ibandronatnu kiselinu Teva: - ako ste alergični (preosjetljivi) na druge bisfosfonate - ako imate problema s gutanjem ili probavom. - ako imate visoke ili niske razine vitamina
English: This is because Ibandronic Acid Teva can affect the way some other medicines work.
Croatian: Ibandronatna kiselina Teva može utjecati na djelovanje drugih lijekova.
English: Prevention of skeletal events in patients with breast cancer and bone metastases with ibandronic acid 50 mg tablets was assessed in two randomized placebo controlled phase III trials with a duration of 96 weeks.
Croatian: Prevencija koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama davanjem tableta ibandronatne kiseline od 50 mg ocijenjena je u dva randomizirana, placebom kontrolirana ispitivanja faze III u trajanju od 96 tjedana.
English: What you need to know before you take Ibandronic Acid Teva
Croatian: Što morate znati prije nego počnete uzimati Ibandronatnu kiselinu Teva
English: Ibandronic Acid Teva tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day.
Croatian: Tablete Ibandronatne kiseline Teva treba uzimati natašte, nakon noćnog gladovanja (barem 6 sati) i prije uzimanja prvog jutarnjeg obroka ili pića.
English: Table 4: Results from 3 years fracture study MF 4411 (%, 95 % CI) for patients with lumbar spine BMD T-score below -2.5 at baseline
Croatian: Tablica 4: Rezultati trogodišnjeg ispitivanja prijeloma iz ispitivanja MF 4411 (%, 95% CI) za bolesnike čija je početna T-vrijednost BMD lumbalne kralježnice bila manja od -2,5
English: The difference between the apparent total and renal clearances is considered to reflect the uptake by bone.
Croatian: Smatra se da razlika između prividnog ukupnog i bubrežnog klirensa odražava apsorpciju od strane kostiju.
English: A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
Croatian: Dokazano je smanjenje rizika od prijeloma kralježaka, a djelotvornost u smanjenju prijeloma kuka nije pokazana.
English: Maximum observed plasma concentrations were reached within 0.5 to 2 hours (median 1 hour) in the fasted state and absolute bioavailability was about 0.6%.
Croatian: Maksimalne zabilježene koncentracije u plazmi postignute su u vremenu od 0,5 do 2 sata (medijan 1 sat) nakon uzimanja lijeka natašte, a apsolutna bioraspoloživost bila je oko 0,6%.
English: Table 1: Adverse reactions occurring in postmenopausal women receiving ibandronic acid 150 mg once monthly or ibandronic acid 2.5 mg daily in the phase III studies BM 16549 and MF 4411 and in post-marketing experience.
Croatian: Tablica 1: Nuspojave koje se pojavljuju u žena u postmenopauzi koje primaju tablete ibandronatne kiseline 150 mg jedanput mjesečno ili 2,5 mg ibandronatne kiseline jedanput dnevno u ispitivanjima faze III BM16549 i MF4411 i u razdoblju nakon stavljanja lijeka na tržište
English: - Take one Ibandronic Acid Teva 150 mg tablet once a month.
Croatian: - Uzimajte jednu tabletu Ibandronatne kiseline Teva 150 mg jedanput mjesečno.
English: There was also a 38% reduction in the risk of developing an SRE for ibandronic acid treated patients when compared with placebo (relative risk 0.62, p=0.003).
Croatian: U usporedbi s placebo grupom, u bolesnika liječenih ibandronatnom kiselinom rizik od razvoja SRE bio je za 38% manji (relativni rizik 0,62; p=0,003).
English: Patients with renal impairment Exposure to ibandronic acid in patients with various degree of renal impairment is related to creatinine clearance (CLcr).
Croatian: Izloženost ibandronatnoj kiselini u bolesnika s različitim stupnjevima oštećenja bubrega povezana je s klirensom kreatinina (CLcr).
English: No evidence of direct foetal toxicity or teratogenic effects was observed for ibandronic acid in intravenously or orally treated rats and rabbits.
Croatian: Nije bilo dokaza izravne fetalne toksičnosti ili teratogenog učinka u štakora i zečeva kojima je ibandronatna kiselina primijenjena intravenski ili peroralno.
English: In healthy male volunteers and postmenopausal women, intravenous administration of ranitidine caused an increase in ibandronic acid bioavailability of about 20%, probably as a result of reduced gastric acidity.
Croatian: U zdravih muških ispitanika i žena u postmenopauzi, intravenska primjena ranitidina uzrokovala je povećanje bioraspoloživosti ibandronatne kiseline za otprilike 20%, vjerojatno kao rezultat smanjene kiselosti želuca.
English: Patients with hepatic impairment (see section 4.2)
Croatian: Bolesnici s oštećenjem jetre (vidjeti dio 4.2)
English: No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal or greater than 30 ml/min.
Croatian: Prilagodba doze nije potrebna u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega, čiji je klirens kreatinina jednak ili veći od 30 ml/min.
English: Total hip BMD
Croatian: BMD cijelog kuka
English: - Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions.
Croatian: radioterapija glave i vrata - loša oralna higijena, periodontalna bolest, loše postavljena zubna proteza, zubna bolest u anamnezi, invazivni stomatološki zahvati, npr. vađenje zuba
English: Ibandronic acid 50 mg n=287
Croatian: Ibandronatna kiselina 50 mg n=287
English: Ibandronic Acid Teva therapy should only be initiated by physicians experienced in the treatment of cancer.
Croatian: Terapiju Ibandronatnom kiselinom Teva smiju započeti samo liječnici s iskustvom u liječenju zloćudnih bolesti.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) an adjustment in the dose is recommended (see section 4.2).
Croatian: U bolesnika s umjerenim (CLcr ≥30 i <50 ml/min) ili teškim oštećenjem bubrega (CLcr <30 ml/min) preporučuje se prilagodba doze (vidjeti dio 4.2).
English: Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Ibandronic Acid Teva.
Croatian: Uzimanje lijekova za smanjenje kiseline u želucu poput cimetidina i ranitidina može neznatno povećati učinak Ibandronatne kiseline Teva.
English: Due to limited clinical experience, Ibandronic Acid Teva is not recommended for patients with a creatinine clearance below 30 ml/min (see section 5.2).
Croatian: Zbog ograničenog kliničkog iskustva, Ibandronatna kiselina Teva ne preporučuje se u bolesnika čiji je klirens kreatinina ispod 30 ml/min (vidjeti dio 5.2).
English: You should take one tablet the next morning after the day you remember; then, continue taking one tablet once a month on the scheduled days you've marked on your calendar.
Croatian: Uzmite jednu tabletu prvo sljedeće jutro nakon što ste se sjetili da ste zaboravili uzeti propisanu dozu; zatim ponovno počnite uzimati jednu tabletu mjesečno na onaj dan u mjesecu koji ste označili u kalendaru.
English: Then you can have your first food and drink, and take any medicines or supplements.
Croatian: Nakon toga možete uzeti svoj prvi jutarnji obrok, piće i druge lijekove ili nadomjesne pripravke.
English: These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
Croatian: Ti poprečni i kratki kosi lomovi mogući su bilo gdje na bedrenoj kosti, odmah ispod malog trohantera pa sve do iznad suprakondilarnog područja.
English: You should wait until the next scheduled dose is due and take it as normal; then, continue taking one tablet once a month on the scheduled days you've marked on your calendar.
Croatian: Pričekajte do datuma uzimanja sljedeće doze označene u Vašem kalendaru i uzmite je kao i obično; zatim ponovno počnite uzimati jednu tabletu jednom mjesečno na onaj dan u mjesecu koji ste označili u kalendaru.
English: In reproductive studies in rats by the intravenous route, ibandronic acid decreased sperm counts at doses of 0.3 and 1 mg/kg/day and decreased fertility in males at 1 mg/kg/day and in females at 1.2 mg/kg/day.
Croatian: U reproduktivnim ispitivanjima na štakorima koji su lijek primali intravenski, ibandronatna je kiselina smanjila broj spermija pri dozama od 0,3 i 1 mg/kg na dan te smanjila plodnost u mužjaka pri dozi od 1 mg/kg na dan, a u ženki pri dozi od 1,2 mg/kg na dan.
English: BMD - mean change relative to baseline total hip at year 3
Croatian: BMD - srednja promjena u odnosu na početne vrijednosti za cijeli kuk nakon 3 godine