natgillin/translations-raw huggingface dataset:
Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours. 
Intravenski primijenjena zoledronatna kiselina eliminirana je procesom u 3 faze: brzo dvofazno nestajanje iz sustavne cirkulacije, s poluvijekom od t½α 0,24 i t½β 1,87 sati, nakon čega slijedi faza duge eliminacije sa završnim poluvijekom eliminacije od t½y 146 sati.
The highest non-lethal single intravenous dose was 10 mg/kg body weight in mice and 0.6 mg/kg in rats. 
U miševa je najviša neletalna pojedinačna intravenska doza bila 10 mg/kg tjelesne težine, a u štakora 0,6 mg/kg.
Frequency categories are defined using the following convention: very common (≥1/10); common 
Kategorije učestalosti određene su na sljedeći način: vrlo često (≥1/10), često
No teratological or embryo/foetal effects were observed in rabbits, although maternal toxicity was marked at 0.1 mg/kg due to decreased serum calcium levels. 
U kunića nisu zapaženi teratološki ili embrio/fetalni učinci, iako je toksičnost za majku bila izrazita pri dozi od 0,1 mg/kg zbog smanjenih razina kalcija u serumu.
Your doctor, pharmacist or nurse knows how to store Zoledronic acid Teva Generics properly. 
Vaš liječnik, ljekarnik ili medicinska sestra znaju kako pravilno čuvati Zoledronatnu kiselinu Teva
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 
Sav neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno lokalnim propisima.
This includes e.g. Zometa or Aclasta (medicines that also contain zoledronic acid and are used to treat the same disease or osteoporosis and other non-cancer diseases of the bone). 
Ti lijekovi uključuju primjerice Zometu ili Aclastu (lijekovi koji također sadrže zoledronatnu kiselinu i primjenjuju se za liječenje iste bolesti ili osteoporoze i drugih nekancerogenih bolesti kostiju).
* Common in Paget's disease only. 
* Često samo pri Pagetovoj bolesti.
Bone histology was evaluated in 7 patients with Paget's disease 6 months after treatment with 5 mg zoledronic acid. 
Histologija kostiju procijenjena je u 7 bolesnika s Pagetovom bolešću 6 mjeseci nakon liječenja sa 5 mg zoledronatne kiseline.
At 24 months a similar significant increase of 3.6% in total hip BMD was observed for patients treated with zoledronic acid as compared to the effects observed in post-menopausal women in the HORIZON-PFT study. 
Nakon 24 mjeseca zapaženo je slično značajno povećanje od 3,6% BMD-a cijelog kuka u bolesnika liječenih zoledronatnom kiselinom u usporedbi s učincima zapaženima u žena u postmenopauzi u ispitivanju HORIZON-PFT.
C-reactive protein increased Uncommon Blood calcium decreased 
Povišen C-reaktivni protein Manje često Snižen kalcij u krvi
There was no progressive reduction of bone turnover markers with repeated annual dosing. 
Nije opaženo progresivno smanjenje markera koštane pregradnje nakon ponovljene godišnje primjene.
The optimal duration of bisphosphonate treatment for osteoporosis has not been established. 
Nije utvrđeno optimalno trajanje liječenja bisfosfonatima u bolesnika s osteoporozom.
Women who were evaluated for the incidence of vertebral fractures did not receive concomitant osteoporosis therapy, which was allowed for women contributing to the hip and all clinical fracture evaluations. 
Žene koje su analizirane s obzirom na incidenciju vertebralnih prijeloma nisu primale istodobnu terapiju za osteoporozu, koja je bila dopuštena kod žena koje su sudjelovale u ispitivanju prijeloma kuka i svih kliničkih prijeloma.
The risk reduction was 51% in bisphosphonate-naïve patients and 42% in patients allowed to take concomitant osteoporosis therapy. 
Sniženje rizika iznosilo je 51% u bolesnika koji ranije nisu dobivali bisfosfonate i 42% u bolesnika kojima je bilo dopušteno istovremeno uzimati lijekove za liječenje osteoporoze.
• Reminder card with the following key messages: o Need to calculate creatinine clearance based on actual body weight using the CockcroftGault formula before each treatment with Zoledronic acid Teva Generics o Contraindication in patients with creatinine clearance < 35 ml/min o Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity o Need to ensure appropriate hydration of the patient especially those at an advanced age and those receiving diuretic therapy o Need to infuse Zoledronic acid Teva Generics slowly over a period of no less than 15 minutes o Once-yearly dosing regime o Adequate calcium and vitamin D intake are recommended in association with zoledronic acid administration o Need for appropriate physical activity, non-smoking and healthy diet 
• Podsjetnik na kojem su navedene sljedeće ključne poruke: o Potreba izračunavanja klirensa kreatinina na temelju stvarne tjelesne težine korištenjem Cockcroft-Gaultove formule prije svakog liječenja Zoledronatnom kiselinom Teva Generics o Kontraindikacija u bolesnika s klirensom kreatinina <35 ml/min o Kontraindikacija u trudnica i u dojilja zbog potencijalne teratogenosti o Potreba da se osigura odgovarajuća hidracija bolesnika, osobito onih starije dobi i onih koji primaju terapiju diureticima o Potreba za primjenom infuzije Zoledronatne kiseline Teva generics polako tijekom razdoblja koje ne traje manje od 15 minuta o Režim doziranja jednom godišnje o Preporučuje se odgovarajući unos kalcija i vitamina D uz primjenu zoledronatne kiseline o Potreba za primjerenom fizičkom aktivnošću, nepušenjem i zdravom prehranom
• Contraindication in patients with severe kidney problems 
• Kontraindikacija u bolesnika s teškim bubrežnim tegobama
Longer-term repeat administration at cumulative exposures sufficiently exceeding the maximum intended human exposure produced toxicological effects in other organs, including the gastrointestinal tract and liver, and at the site of intravenous administration. 
Dugotrajna ponovljena primjena pri kumulativnim izloženostima koje su dovoljno prekoračivale najveću planiranu izloženost u ljudi izazvala je toksične učinke na drugim organima, uključujući probavni sustav i jetru, kao i na mjestu primjene.
It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Zoledronic acid Teva Generics, as directed by your healthcare provider. 
Važno je da popijete najmanje 2 čaše tekućine (kao što je voda), unutar nekoliko sati prije primanja Zoledronatne kiseline Teva Generics, prema uputama zdravstvenog djelatnika.
Effect on all clinical fractures The incidence rates of key clinical fracture variables are presented in Table 4. 
Učinak na sve kliničke prijelome Stope incidencije ključnih varijabli kliničkih prijeloma prikazane su u Tablici 4.
After initiation of the zoledronic acid infusion, plasma concentrations of the active substance increased rapidly, achieving their peak at the end of the infusion period, followed by a rapid decline to < 10% of peak after 4 hours and < 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak levels. 
Nakon početka primjene infuzije zoledronatne kiseline, koncentracija zoledronatne kiseline u plazmi naglo se povećala, dosegnuvši vršnu koncentraciju na kraju infuzije, nakon čega je uslijedio brzi pad do <10% od vršne koncentracije nakon 4 sata te <1% od vršne koncentracije nakon 24 sata, s posljedičnim produženim razdobljem vrlo niskih koncentracija koje nisu prelazile 0,1% vršne koncentracije.
Treatment of Paget's disease of the bone in adults. 
Liječenje Pagetove bolesti kosti u odraslih.
Tetracycline label was detectable in all but one of 82 biopsies obtained from patients on zoledronic acid. 
Tetraciklinsko obilježavanje otkriveno je kod svih osim jednog od 82 uzorka uzetih biopsijom od bolesnica na zoledronatnoj kiselini.
After 6 months, zoledronic acid showed 96% (169/176) and 89% (156/176) response and serum alkaline phosphatase (SAP) normalisation rates compared to 74% (127/171) and 58% (99/171) for risedronate (all p<0.001). 
Nakon 6 mjeseci pri primjeni zoledronatne kiseline zabilježen je odgovor od 96% (169/176) te normalizacija razina alkalne fosfataze u serumu od 89% (156/176) u usporedbi sa 74% (127/171), odnosno 58% (99/171) pri primjeni risedronata (sve p<0,001).
Efficacy was demonstrated if non-inferiority to risedronate was shown sequentially with respect to the percentage change in lumbar spine BMD at 12 months relative to baseline in the treatment and prevention subpopulations, respectively. 
Djelotvornost je bila postignuta ako sekvencijski nije ustanovljena inferiornost u odnosu na risedronat s obzirom na postotak promjene BMD-a lumbalne kralježnice nakon 12 mjeseci u odnosu na početne vrijednosti u liječenju i u odnosu na prevenciju u subpopulacijama.
Adverse reactions, such as dizziness, may affect the ability to drive or use machines, though no studies on this effect with zoledronic acid have been performed. 
Nuspojave, kao što je omaglica, mogu utjecati na sposobnost upravljanja vozilima i rada na strojevima, premda nisu provedena ispitivanja ovog učinka sa zoledronatnom kiselinom.
It belongs to a group of medicines called bisphosphonates and is used to treat post-menopausal women and adult men with osteoporosis or osteoporosis caused by treatment with steroids, and Paget's disease of the bone in adults. 
Pripada skupini lijekova koji se nazivaju bisfosfonati i koristi se za liječenje žena u postmenopauzi i odraslih muškaraca s osteoporozom ili za liječenje osteoporoze izazvane liječenjem steroidima te za liječenje
Zoledronic acid demonstrated a consistent effect over 3 years, resulting in a 41% reduction in the risk of hip fractures (95% CI, 17% to 58%). 
Zoledronatna kiselina pokazala je konzistentne učinke tijekom 3 godine, što je dovelo do smanjenja rizika od prijeloma kuka za 41% (95% CI, 17% do 58%).
85% of patients were bisphosphonate-naïve. 
85% bolesnica do tada nije primalo bisfosfonate.
Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08 
Farmakoterapijska skupina: lijekovi za liječenje bolesti kostiju, bisfosfonati, ATK oznaka: M05BA08 Mehanizam djelovanja
Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category. 
Nuspojave navedene u Tablici 1 poredane su po klasifikaciji organskih sustava prema MedDRA-i i po kategoriji učestalosti.
Re-treatment of Paget's disease: After initial treatment with zoledronic acid in Paget's disease an extended remission period is observed in responding patients. 
Ponovno liječenje Pagetove bolesti: nakon početnog liječenja Pagetove bolesti zoledronatnom kiselinom zapaženo je produljeno razdoblje remisije u bolesnika koji su odgovorili na liječenje.
• in adult men at increased risk of fracture, including those with a recent low-trauma hip fracture. 
• u žena u postmenopauzi • u odraslih muškaraca s povećanim rizikom od prijeloma, uključujući one koji su nedavno imali prijelom kuka nakon slabe traume.
Your doctor should do a blood test to check your kidney function before each dose of Zoledronic acid Teva Generics. 
Liječnik Vam mora napraviti krvnu pretragu kako bi Vam provjerio bubrežnu funkciju prije svake doze Zoledronatne kiseline Teva Generics.
In another study in men (study CZOL446M2308) an annual infusion of zoledronic acid was non-inferior to weekly alendronate for the percentage change in lumbar spine BMD at month 24 relative to baseline. 
U drugom ispitivanju u muškaraca (ispitivanje CZOL446M2308) godišnja infuzija zoledronatne kiseline nije bila lošija od tjedne primjena alendronata s obzirom na postotak promjene BMD-a lumbalne kralježnice nakon 24 mjeseca u odnosu na početne vrijednosti.
Of the 153 zoledronic acid-treated patients and 115 risedronate-treated patients who entered an extended observation study, after a mean duration of follow-up of 3.8 years from time of dosing, the proportion of patients ending the Extended Observation Period due to the need for re-treatment (clinical judgment) was higher for risedronate (48 patients, or 41.7%) compared with zoledronic acid (11 patients, or 7.2%). 
Od 153 bolesnika liječenih zoledronatnom kiselinom i 115 bolesnika liječenih risedronatom, koji su ušli u produljenu studiju praćenja, nakon srednjeg trajanja praćenja od 3,8 godina, računato od vremena doziranja, udio bolesnika koji su završili produljeno razdoblje praćenja zbog potrebe za ponovnim liječenjem (klinička procjena) bio je viši u skupini koja je primala risedronat (48 bolesnika, odnosno 41,7%) nego u onoj koja je primala zoledronatnu kiselinu (11 bolesnika, odnosno 7,2%).
For osteoporosis, Zoledronic acid Teva Generics works for one year. 
U slučaju osteoporoze, Zoledronatna kiselina Teva Generics djeluje tijekom godine dana.
In a large clinical trial, local reactions at the infusion site, such as redness, swelling and/or pain, were reported (0.7%) following the administration of zoledronic acid. 
U velikom kliničkom ispitivanju zabilježene su (0,7%) lokalne reakcije na mjestu infuzije, kao što su crvenilo, oticanje i/ili bol nakon primjene zoledronatne kiseline.
The pack sizes of 5 and 10 bottles are only available in multipacks. 
Pakiranja sa 5 i 10 bočica dostupna su samo kao višestruka pakiranja
In both women and men, Zoledronic acid Teva Generics strengthens the bone and therefore makes it less likely to break. 
I u žena i u muškaraca Zoledronatna kiselina Teva Generics jača kost i na taj način smanjuje vjerojatnost posljedičnog prijeloma.
In the Paget's disease trials, symptomatic hypocalcaemia was observed in approximately 1% of patients, in all of whom it resolved. 
U kliničkim ispitivanjima Pagetove bolesti u otprilike 1% bolesnika opažena je simptomatska hipokalcijemija, koja se kod svih povukla.
Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known 
Kategorije učestalosti određene su na sljedeći način: vrlo često (≥1/10) često (≥1/100 do <1/10) manje često (≥1/1000 do <1/100) rijetko (≥1/10 000 do <1/1000) vrlo rijetko
In the three-year osteoporosis study standing height was measured annually using a stadiometer. 
U trogodišnjem ispitivanju osteoporoze, jednom na godinu mjerena je visina u stojećem položaju uz pomoć stadiometra.
Zoledronic acid Teva Generics must not be mixed or given intravenously with any other medicinal product and must be given through a separate vented infusion line at a constant infusion rate. 
Zoledronatna kiselina Teva Generics ne smije se miješati niti primjenjivati intravenski s drugim lijekovima te se mora dati putem zasebne infuzijske cjevčice s odzračivanjem uz konstantnu brzinu infuzije.
Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy 
Liječenje osteoporoze povezane s dugotrajnim liječenjem sistemskim glukokortikoidima
Zoledronic acid Teva Generics is supplied in packs of 1, 5 or 10 bottles. 
Zoledronatna kiselina Teva Generics dostupna je u pakiranjima sa 1, 5 ili 10 bočica.
In patients with renal impairment, the systemic exposure to concomitant medicinal products that are primarily excreted via the kidney may increase. 
U bolesnika s oštećenjem bubrega, može se povećati sistemska izloženost istovremeno primijenjenim lijekovima koji se primarno izlučuju putem bubrega.
In the osteoporosis trials (PFT, HORIZON - Recurrent Fracture Trial [RFT]) the pooled atrial fibrillation incidences were comparable between zoledronic acid (2.6%) and placebo (2.1%). 
U ispitivanjima osteoporoze (PFT, HORIZON - Recurrent Fracture Trial [RFT]) ukupna incidencija fibrilacije atrija bila je usporediva kod zoledronatne kiseline (2,6%) i placeba (2,1%).
Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and interactions resulting from displacement of highly protein-bound drugs are therefore unlikely. 
Zoledronatna kiselina se ne veže u velikoj mjeri na proteine plazme (veže se otprilike 43-55%) pa zbog toga interakcije nastale istiskivanjem lijekova koji se u velikoj mjeri vežu za proteine nisu vjerojatne.
All patients received adequate supplementation with vitamin D and calcium in the post-menopausal osteoporosis trial, the prevention of clinical fractures after hip fracture trial, and the Paget's disease trials (see also section 4.2). 
Svi su bolesnici primili odgovarajući dodatak vitamina D i kalcija u ispitivanju osteoporoze u postmenopauzi, prevenciji kliničkih prijeloma nakon ispitivanja prijeloma kuka te ispitivanjima Pagetove bolesti (vidjeti također dio 4.2).
• A single dose of zoledronic acid should not exceed 5 mg and the duration of infusion should be at least 15 minutes (see section 4.2). 
• Jednokratna doza zoledronatne kiseline ne smije biti veća od 5 mg, a trajanje infuzije treba biti najmanje 15 minuta (vidjeti dio 4.2).
Concomitant osteoporosis therapy included: calcitonin, raloxifene, tamoxifen, hormone replacement therapy, tibolone; but excluded other bisphosphonates. 
Istodobna terapija osteoporoze uključivala je: kalcitonin, raloksifen, tamoksifen, hormonsko nadomjesno liječenje i tibolon, međutim, isključeni su ostali bisfosfonati.
How to store Zoledronic acid Teva Generics Contents of the pack and other information 
Kako čuvati Zoledronatnu kiselinu Teva Generics Sadržaj pakiranja i druge informacije
Zoledronic acid Teva Generics may also cause other side effects Very common (may affect more than 1 in 10 people) Fever 
Zoledronatna kiselina Teva Generics može uzrokovati i druge nuspojave Vrlo često (mogu se javiti u više od 1 na 10 osoba)
These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture. 
Ti prijelomi nastaju nakon minimalne traume ili bez nje, a neki bolesnici osjete bol u bedru ili preponi, često praćenu radiološkim prikazom stres prijeloma i to tjednima, odnosno mjesecima prije potpunog prijeloma bedrene kosti.
Solution for infusion multipack: 5 bags x 100 ml multipack: 10 bags x 100 ml 
Višestruko pakovanje: 5 bočica x 100 ml Višestruko pakovanje: 10 bočica x 100 ml
Before you receive dental treatment or undergo dental surgery, tell your dentist you are receiving treatment with Zoledronic acid Teva Generics. 
Prije nego što započnete liječenje kod zubara ili ako idete na stomatološki kirurški zahvat, obavijestite svog zubara da se liječite Zoledronatnom kiselinom Teva
- Do not use this medicine if you notice any discolouration or particles in the solution. 
- Ovaj lijek se ne smije upotrijebiti ako primijetite promjenu boje otopine ili čestice u otopini.
Clinical efficacy in the treatment of osteoporosis in patients at increased risk of fracture after a recent hip fracture (RFT) 
Klinička djelotvornost u liječenju osteoporoze u bolesnika s povećanim rizikom za prijelom nakon nedavnog prijeloma kuka
Ask your doctor, pharmacist or nurse for advice before taking this medicine. 
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri za savjet prije nego što uzmete ovaj lijek.
The incidence of post-dose symptoms occuring within the first three days after administration of zoledronic acid can be reduced with the administration of paracetamol or ibuprofen shortly following zoledronic acid administration. 
Incidencija simptoma nakon doze koji se javljaju u roku od prva tri dana nakon primjene zoledronatne kiseline može se smanjiti primjenom paracetamola ili ibuprofena ubrzo nakon primjene zoledronatne kiseline.
Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less than 2.10 mmol/l) occurred in 2.3% of zoledronic acid-treated patients in a large clinical trial compared to 21% of zoledronic acid-treated patients in the Paget's disease trials. 
Na osnovi laboratorijske procjene prolazne asimptomatske razine kalcija ispod normalnog referentnog raspona (manje od 2,10 mmol/l) zabilježene su u 2,3% bolesnika liječenih zoledronatnom kiselinom u velikom kliničkom ispitivanju u usporedbi sa 21% bolesnika liječenih zoledronatnom kiselinom u kliničkim ispitivanjima Pagetove bolesti.
Hypocalcaemia 
Hipokalcijemija
The incidence of these reactions decreased markedly with subsequent annual doses of zoledronic acid. 
Incidencija tih nuspojava značajno se smanjila sa sljedećim godišnjim dozama zoledronatne kiseline.
Days of disability 
Broj dana fizičke onesposobljenosti
Vitamin D levels were not routinely measured but a loading dose of vitamin D (50,000 to 125,000 IU orally or via the intramuscular route) was given to the majority of patients 2 weeks prior to infusion. 
D nisu se rutinski mjerile, ali većina bolesnika je primila dodatnu dozu vitamina D (50 000 do 125 000 IU peroralno ili intramuskularno) 2 tjedna prije infuzije.
The zoledronic acid group revealed approximately 2.5 mm less height loss compared to placebo (95% CI: 1.6 mm, 3.5 mm) [p<0.0001]. 
Skupina na zoledronatnoj kiselini pokazala je otprilike 2,5 mm manji gubitak tjelesne visine u usporedbi s placebom (95% CI: 1,6 mm, 3,5 mm) [p<0,0001].
Zoledronic acid is not metabolised and is excreted unchanged via the kidney. 
Zoledronatna kiselina se ne metabolizira te se izlučuje nepromijenjena putem bubrega.
Uncommon Lethargy, paraesthesia, somnolence, tremor, syncope, dysgeusia 
Manje često Letargija, parestezija, somnolencija, tremor, sinkopa, disgeusija
The incidence of fractures was 8 for zoledronic acid-treated patients versus 7 for risedronate-treated patients (p=0.8055). 
Incidencija prijeloma bila je 8 bolesnika liječenih zoledronatnom kiselinom naspram 7 bolesnika liječenih risedronatom (p=0,8055).
Pliva Ljubljana d.o.o. 
Pliva Hrvatska d.o.o. Tel.
Zoledronic acid has been associated with renal impairment manifested as deterioration in renal function (i.e. increased serum creatinine) and in rare cases acute renal failure. 
Zoledronatna kiselina bila je povezana s oštećenjem funkcije bubrega koje se očitovalo kao slabljenje bubrežne funkcije (npr. povišena razina kreatinina u serumu) i u rijetkim slučajevima kao akutno zatajenje bubrega.
Six patients who achieved therapeutic response 6 months after treatment with zoledronic acid and later experienced disease relapse during the extended follow-up period were re-treated with zoledronic acid after a mean time of 6.5 years from initial treatment to re-treatment. 
Šest bolesnika u kojih je postignut terapijski odgovor nakon 6 mjeseci liječenja zoledronatnom kiselinom i u kojih je kasnije tijekom razdoblja praćenja zabilježen relaps, ponovo su liječeni zoledronatnom kiselinom nakon srednjeg vremena od 6,5 godina nakon početnog do ponovnog liječenja.
Zoledronic acid treatment rapidly reduced the rate of bone turnover from elevated post-menopausal levels with the nadir for resorption markers observed at 7 days, and for formation markers at 12 weeks. 
Liječenje zoledronatnom kiselinom dovelo je do brzog smanjenja stope pregradnje kosti s povišenih razina u postmenopauzi, pri čemu je najniža vrijednost markera resorpcije opažena 7. dana, a markera izgradnje kosti u 12. tjednu.
Clinical efficacy in the treatment of post-menopausal osteoporosis (PFT) The efficacy and safety of zoledronic acid 5 mg once a year for 3 consecutive years were demonstrated in post-menopausal women (7,736 women aged 65-89 years) with either: a femoral neck bone mineral density (BMD) with a T-score ≤ -1.5 and at least two mild or one moderate existing vertebral fracture(s); or a femoral neck BMD T-score ≤ -2.5 with or without evidence of existing vertebral fracture(s). 
Djelotvornost i sigurnost primjene zoledronatne kiseline u dozi od 5 mg jednom na godinu tijekom tri uzastopne godine dokazane su kod žena u postmenopauzi (7736 žena u dobi od 65 do 89 godina) s jednim od dva uvjeta: BMD T-vrijednost vrata bedrene kosti ≤ -1,5 te najmanje dva blaga ili jedan umjereno teški postojeći vertebralni prijelom; ili BMD T-vrijednost vrata bedrene kosti ≤ -2,5 sa znakovima postojećeg(ih) vertebralnog(ih) prijeloma ili bez njih.