FrancophonIA/ELRC3.0 huggingface dataset:
English: It is important that you continue taking PROTELOS for as long as your doctor prescribes the medicine.
Croatian: Važno je da nastavite uzimati PROTELOS sve dok Vam Vaš liječnik propisuje lijek.
English: Your doctor should be able to advise if a blood test is necessary before taking PROTELOS.
Croatian: Vaš liječnik može vam savjetovati da li je potrebno provesti pretrage krvi prije uzimanja PROTELOSa.
English: What you need to know before you take PROTELOS
Croatian: Što morate znati prije nego počnete uzimati PROTELOS
English: Your doctor will evaluate the conditions of your heart and blood vessels regularly, generally every 6 to 12 months for as long you are taking PROTELOS.
Croatian: Vaš liječnik će redovito procjenjivati stanje Vašeg srca i krvnih žila, po pravilu svakih 6 do 12 mjeseci dok god uzimate PROTELOS.
English: PROTELOS can treat your severe osteoporosis only if you continue to take it.
Croatian: PROTELOS može liječiti Vašu tešku osteoporozu samo ako nastavite uzimati lijek.
English: Annopol 6B - 03-236 Warszawa, Poland The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Croatian: Annopol 6B - 03-236 Varšava, Poljska Na tiskanoj uputi o lijeku mora se navesti naziv i adresa proizvođača odgovornog za puštanje navedene serije u promet.
English: PROTELOS has been studied in clinical trials involving nearly 8,000 participants.
Croatian: PROTELOS je ispitivan u kliničkim ispitivanjima koja su obuhvatila otprilike 8000 ispitanika.
English: PROTELOS can interact with milk and milk products, so it is important that you mix PROTELOS only with water to be sure it works properly.
Croatian: PROTELOS može stupiti u interakciju s mlijekom i mliječnim proizvodima te je stoga važno da PROTELOS miješate isključivo s vodom, kako biste bili sigurni da će ispravno djelovati.
English: If you have stopped treatment due to hypersensitivity reactions, do not take PROTELOS again.
Croatian: Ukoliko ste prestali uzimati lijek zbog reakcija preosjetljivosti, nemojte ponovo uzimati PROTELOS.
English: Talk to your doctor or pharmacist before taking PROTELOS: - if you are at risk of heart disease, this includes high blood pressure, high cholesterol, diabetes,
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete PROTELOS: - ako imate rizik za srčanu bolest, što uključuje visoki krvni tlak, visoku razinu kolesterola,
English: The safety and efficacy of PROTELOS in children aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka PROTELOS u djece mlađe od 18 godina nisu još ustanovljene.
English: If you stop taking PROTELOS:
Croatian: Ako prestanete uzimati PROTELOS:
English: You may lie down immediately after taking PROTELOS if you wish.
Croatian: Želite li, možete prileći odmah nakon što ste uzeli PROTELOS
English: This should be taken into account when interpreting BMD changes during treatment with PROTELOS.
Croatian: To valja imati na umu pri tumačenju promjena BMD pri liječenju PROTELOS-om.
English: If you forget to take PROTELOS:
Croatian: Ako ste zaboravili uzeti PROTELOS:
English: Adverse reactionsare listed below 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 (cannot be estimated from the available data).
Croatian: Nuspojave su navedene niže i prema učestalosti razvrstane 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 (<1/10 000); nepoznato (učestalost se ne može procijeniti iz dostupnih podataka).
English: If you need to have blood or urine tests to check your level of calcium, you should tell the laboratory that you are taking PROTELOS as it may interfere with some testing methods.
Croatian: Ako morate obaviti pretrage krvi ili mokraće kako biste provjerili razinu kalcija, obavijestite osoblje laboratorija da uzimate PROTELOS budući da on može utjecati na neke metode pretraga.
English: In each Member State where PROTELOS is marketed, the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.
Croatian: U svakoj zemlji članici u kojoj se PROTELOS nalazi na tržištu, nositelj odobrenja dogovorit će završni edukacijski program sa nacionalnim nadležnim tijelom.
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where PROTELOS is marketed, all physicians who are expected to prescribe PROTELOS are provided with the following educational package:
Croatian: Nositelj odobrenja će osigurati da, nakon rasprave i dogovora sa nacionalnim nadležnim tijelom svake države članice gdje je PROTELOS prisutan na tržištu, svi liječnici za koje se očekuje da će propisivati PROTELOS dobiju edukacijski paket koji sadrži:
English: PROTELOS is supplied in boxes of 7, 14, 28, 56, 84 or 100 sachets.
Croatian: PROTELOS je pakiran u kutijama sa 7, 14, 28, 56, 84 ili 100 vrećica.
English: It is recommended that you take PROTELOS in-between meals, preferably at bedtime at least two hours after food, milk or milk products or calcium supplements.
Croatian: Preporučuje se da PROTELOS uzimate između obroka, po mogućnosti u vrijeme odlaska na spavanje, najmanje dva sata nakon jela, obroka mlijeka, mliječnih proizvoda ili nakon uzimanja dodataka kalcija.
English: Do not take PROTELOS during pregnancy or when you are breastfeeding.
Croatian: Nemojte uzimati PROTELOS u trudnoći ili kada dojite.
English: If you develop a rash or serious skin symptoms (see section 4), stop taking PROTELOS, seek urgent advice from a doctor and tell him that you are taking this medicine.
Croatian: Ukoliko razvijete osip ili ozbiljne kožne simptome (pogledajte dio 4) prestanite uzimati PROTELOS, hitno zatražite savjet liječnika i recite mu da uzimate ovaj lijek.
English: Table 1: Incidence of patients with vertebral fracture and relative risk reduction
Croatian: Tablica 1: Incidencija prijeloma vratne kralješnice i smanjenje relativnog rizika
English: • The initiation of treatment with PROTELOS should be based on an assessment of the individual patient's overall risk.
Croatian: • Započinjanje liječenja PROTELOS-om mora se temeljiti na procjeni ukupnog individualnog rizika za bolesnika.
English: The European Medicines Agency has waived the obligation to submit the results of studies with PROTELOS in all subsets of the paediatric population in osteoporosis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja PROTELOS-a u svim podskupinama pedijatrijske populacije u osteoporozi (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: When treating patients over 80 years at risk of VTE, the need for continued treatment with PROTELOS should be re-evaluated.
Croatian: Pri liječenju bolesnika starijih od 80 godina s rizikom od VTE, potrebno je preispitati nastavak liječenja s PROTELOS-om.
English: As a precautionary measure, PROTELOS treatment should be suspended during treatment with oral tetracycline or quinolone antibiotics.
Croatian: Kao mjeru opreza, primjenu PROTELOS-a mora se obustaviti za vrijeme liječenja peroralnim tetraciklinskim ili kinolonskim antibioticima.
English: What PROTELOS looks like and contents of the pack PROTELOS is available in sachets containing yellow granules for oral suspension.
Croatian: Kako PROTELOS izgleda i sadržaj pakiranja PROTELOS je dostupan u vrećicama koje sadrže žute granule za pripremu oralne suspenzije.
English: Quality of life assessment on the QUALIOST specific scale as well as the General Health perception score of the SF-36 general scale indicated benefit of PROTELOS, compared with placebo.
Croatian: Procjena kvalitete života specifičnom ljestvicom QUALIOST, kao i procjenom općeg zdravstvenog stanja (General Health perception score) ljestvicom SF-36 također je pokazala koristi PROTELOS-a u odnosu na placebo.
English: How to take PROTELOS
Croatian: Kako uzimati PROTELOS
English: The highest risk for occurrence of SJS or TEN is within the first weeks of treatment and usually around 3-6 weeks for DRESS.
Croatian: Najveći rizik od pojave SJS ili TEN je unutar prvih tjedana liječenja, a za DRESS obično oko 3-6 tjedana.
English: • The contraindications to the treatment with PROTELOS.
Croatian: • Kontraindikacije za primjenu PROTELOS-a.
English: Therefore, administration of PROTELOS and such products should be separated by at least two hours (see sections 4.2 and 5.2).
Croatian: Stoga razmak između uzimanja PROTELOS-a i tih proizvoda mora iznositi najmanje dva sata (vidjeti dijelove 4.2 i 5.2)
English: With respect to clinical vertebral fractures (defined as fractures associated with back pain and/or a body height loss of at least 1 cm), the relative risk was reduced by 38%.
Croatian: S obzirom na kliničke prijelome kralješnice (definirane kao prijelome povezane s boli u leđima i/ili smanjenjem visine tijela za barem 1 cm), PROTELOS je rizik od tih prijeloma smanjio za 38 %.
English: Due to the relatively slow absorption of strontium, food and calcium intake should be avoided both before and after administration of PROTELOS.
Croatian: Zbog razmjerno spore apsorpcije stroncija, kalcij i hranu treba izbjegavati i prije i nakon uzimanja PROTELOS-a.
English: PROTELOS, which contains the substance strontium ranelate, belongs to a group of medicines used to treat bone diseases.
Croatian: PROTELOS, koji sadrži djelatnu tvar stroncijev ranelat, pripada skupini lijekova koji se koriste za liječenje bolesti kostiju.
English: PROTELOS should be discontinued as soon as possible in the event of an illness or a condition leading to immobilisation (see section 4.3) and adequate preventive measures taken.
Croatian: Liječenje PROTELOS-om treba što je prije moguće prekinuti u slučaju bolesti ili stanja koje dovodi do imobilizacije (vidjeti dio 4.3) te provesti preventivne mjere.
English: If the following happens to you, stop using PROTELOS and talk to your doctor immediately:
Croatian: Ako Vam se dogodi bilo što od niže navedenog, prekinite sa uzimanjem PROTELOS-a i odmah razgovarajte sa svojim liječnikom:
English: • PROTELOS should only be used with caution in: o Patients with significant risk factors for cardiovascular events such as hypertension, hyperlipidaemia, diabetes mellitus or smoking.
Croatian: • PROTELOS smije se primjenjivati samo uz oprez u: o Bolesnika sa značajnim čimbenicima rizika za nastanak kardiovaskularnih događaja kao što su hipertenzija, hiperlipidemija, diabetes mellitus ili pušenje.
English: If tests are positive for one or both alleles, PROTELOS should not be started.
Croatian: Ukoliko je nalaz pozitivan za jedan ili oba alela, ne smije se započeti liječenje PROTELOS-om.
English: PROTELOS contains aspartame, a source of phenylalanine, which may be harmful for people with phenylketonuria.
Croatian: Pomoćna tvar PROTELOS sadržava aspartam, izvor fenilalanina, koji može biti štetan za osobe s fenilketonurijom.
English: Manufacturer(s) Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy
Croatian: Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy
English: Your doctor may advise you to take calcium and vitamin D supplements in addition to PROTELOS.
Croatian: Vaš će Vam liječnik možda savjetovati da uz PROTELOS uzimate i nadopunu kalcija i vitamina D.
English: If you take more sachets of PROTELOS than recommended by your doctor, tell your doctor or pharmacist.
Croatian: Uzmete li više vrećica PROTELOS-a nego što Vam je preporučio liječnik, kažite to svome liječniku ili ljekarniku.
English: PROTELOS contains aspartame (E951):
Croatian: PROTELOS sadrži aspartam (E951):
English: Continuation of treatment with PROTELOS in patients developing severe renal impairment should be considered on an individual basis.
Croatian: Nastavak terapije PROTELOS-om u bolesnika u kojih je nastupilo teško oštećenje bubrega mora se razmotriti na individualnoj osnovi.
English: The anti-fracture studies program of PROTELOS was made up of two placebo-controlled phase III studies: SOTI study and TROPOS study.
Croatian: Program ispitivanja PROTELOS-a u sprječavanju prijeloma sastojao se od dvaju placebom kontroliranih ispitivanja III. faze: ispitivanje SOTI i ispitivanje TROPOS.
English: During PROTELOS treatment, these cardiovascular risks should be monitored on a regular basis generally every 6 to 12 months.
Croatian: Tijekom liječenja PROTELOS-om, ovi kardiovaskularni rizici trebaju se pratiti u redovitim intervalima, u pravilu svakih 6 do 12 mjeseci.
English: Given the slow absorption, PROTELOS should be taken at bedtime, preferably at least two hours after eating (see sections 4.5 and 5.2).
Croatian: Imajući u vidu sporu apsorpciju, PROTELOS treba uzimati u vrijeme odlaska na spavanje, po mogućnosti najmanje dva sata nakon jela (vidjeti dijelove 4.5 i 5.2).
English: EXP If not used immediately after reconstitution, the preparation should be consumed within 24 hours.
Croatian: Ako se ne primijeni odmah nakon pripreme, pripravak se mora popiti unutar 24 sata.
English: Statistically significant increases in BMD were observed as early as 6 months following initiation of PROTELOS treatment versus placebo.
Croatian: Povećanje BMD-a bilo je statistički značajno već 6 mjeseci nakon početka uzimanja PROTELOS-a u usporedbi s placebom.
English: Available data indicate that these factors account for approximately 50% of the measured change in BMD over 3 years of treatment with PROTELOS 2 g/day.
Croatian: Dostupni podaci pokazuju da su ti čimbenici bili odgovorni za oko 50 % izmjerene promjene BMD tijekom 3 godine uzimanja PROTELOS-a u dozi od 2 g/dan.
English: Do not take PROTELOS: - if you are allergic to strontium ranelate or any of the other ingredients of PROTELOS (listed in section 6).
Croatian: Nemojte uzimati PROTELOS: - ako ste preosjetljivi (alergični) na stroncijev ranelat ili na bilo koji drugi sastojak PROTELOS
English: The recommended dose is one 2 g sachet a day.
Croatian: Preporučena doza je jedna vrećica od 2 g na dan.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, France Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul.
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Les Laboratoires Servier Industrie, 905, route de Saran, 45520 Gidy, Francuska Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul.
English: During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must immediately stop taking PROTELOS and seek medical advice (see section 4).
Croatian: Ukoliko Vam se tijekom liječenja dogodi alergijska reakcija (npr. oticanje lica, jezika ili grla, poteškoće u disanju ili gutanju, kožni osip), morate odmah prekinuti uzimanje PROTELOS -a i potražiti pomoć liječnika (pogledajte dio 4).
English: Physico-chemical data suggest excretion of Strontium ranelate in human milk.
Croatian: Fizikalno-kemijski podaci ukazuju da se stroncijev ranelat izlučuje u majčino mlijeko.
English: Intake of strontium ranelate with calcium or food reduces the bioavailability of strontium by approximately 60-70%, compared with administration 3 hours after a meal.
Croatian: stroncijeva ranelata s kalcijem ili s hranom smanjuje se bioraspoloživost stroncija za oko 60-70 % u usporedbi s primjenom 3 sata nakon jela.
English: The outcome of DRESS is favorable in most cases upon discontinuation of PROTELOS and after initiation of corticosteroid therapy when necessary.
Croatian: U većini slučajeva je ishod DRESS-a povoljan nakon prestanka primjene PROTELOS-a i nakon uvođenja liječenja kortikosteroidima kada je neophodno.
English: If PROTELOS is used inadvertently during pregnancy, treatment must be stopped.
Croatian: Uzima li se PROTELOS nehotice u trudnoći, liječenje se mora obustaviti.
English: PROTELOS should not be used during breast-feeding.
Croatian: PROTELOS se ne smije primjenjivati tijekom dojenja.
English: In this group, over 3 years of treatment, PROTELOS reduced the risk of hip fracture by 36% relative to the placebo group (table 2).
Croatian: U te je skupine PROTELOS tijekom 3 godine liječenja smanjio rizik od prijeloma bedrene kosti za 36 % u usporedbi sa skupinom koja je uzimala placebo (Tablica 2).
English: Do not take calcium supplements at bedtime, at the same time as PROTELOS.
Croatian: Nadopunu kalcija nemojte uzimati istodobno s PROTELOS-om u vrijeme odlaska na spavanje.
English: It is recommended that you take PROTELOS at bedtime, preferably at least 2 hours after dinner.
Croatian: Preporučuje se PROTELOS uzimati u vrijeme odlaska na spavanje, barem 2 sata nakon večere.
English: In a pooled analysis of randomised placebo-controlled studies in post-menopausal osteoporotic patients , the most common adverse reactions consisted of nausea and diarrhoea, which were generally reported at the beginning of treatment with no noticeable difference between groups afterwards.
Croatian: U analizi zbirnih podataka iz randomiziranih placebom kontroliranih ispitivanja u bolesnica s osteoporozom u poslijemenopauzi, najčešće nuspojave bile su mučnina i proljev, a općenito su se javljale na početku terapije, te među skupinama kasnije nije bilo uočljivih razlika.
English: and TROPOS enrolled 1,556 patients over 80 years at inclusion (23.1% of the study population).
Croatian: U oba ispitivanja, SOTI i TROPOS, sudjelovalo je 1556 bolesnica starijih od 80 godina pri uključivanju u ispitivanju (23,1 % populacije iz ispitivanja).
English: EU/1/04/288/005 84 sachets (3 packs of 28) EU/1/04/288/006 100 sachets
Croatian: EU/1/04/288/005 84 vrećica (3 pakiranja od 28 vrećica) EU/1/04/288/006 100 vrećica
English: When a VTE occurs, PROTELOS should be stopped.
Croatian: Kada se pojavi VTE, PROTELOS treba odmah prestati uzimati.
English: • PROTELOS is only indicated for use in patients with severe osteoporosis at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance.
Croatian: • PROTELOS je indiciran samo za primjenu u bolesnika s teškom osteoporozom s visokim rizikom za nastanak prijeloma, kod kojih liječenje s drugim lijekovima odobrenima za liječenje osteoporoze nije moguće zbog, na primjer, kontraindikacija ili nepodnošenja.
English: Over 12 months, a statistically significant increase in mean lumbar spine BMD, main efficacy criteria (E (SE) = 5.32% (0.75); 95%CI = [3.86 ; 6.79]; p<0,001), similar to that observed in the pivotal antifracture phase III studies carried-out inpostmenopausal women, was observed.
Croatian: Tijekom 12 mjeseci uočeno je statistički značajno povećanje srednje vrijednosti BMD-a lumbalne kralježnice, glavnog kriterija djelotvornosti (E (SE)=5,32% (0,75); 95%CI [3,86; 6,79]; p=0,001) slično rezultatima pivotalnih ispitivanja III.
English: However, when this dosing regimen is impractical due to the recommended administration of PROTELOS at bedtime, concomitant intake remains acceptable.
Croatian: No kada takav način doziranja nije praktičan zbog preporuke da se PROTELOS uzima u vrijeme odlaska na počinak, prihvatljivo je uzeti oba lijeka istodobno.
English: In phase III studies, which demonstrated the anti-fracture efficacy of PROTELOS treatment, measured mean BMD increased from baseline with PROTELOS by approximately 4% per year at the lumbar spine and 2% per year at the femoral neck, reaching 13% to 15% and 5% to 6% respectively after 3 years, depending on the study.
Croatian: U ispitivanjima III. faze, kojima je dokazana djelotvornost PROTELOS -a u sprječavanju prijeloma, izmjerena BMD povećavala se pri uzimanju PROTELOS -a u odnosu na početnu vrijednost za oko 4 % godišnje u slabinskim kralješcima i oko 2 % godišnje u vratu bedrene kosti te se do kraja istraživanja, nakon 3 godine, ovisno o istraživanju, povećala za ukupno 13 % do 15 %, odnosno za 5 % do 6 %, ovisno o istraživanju.
English: PROTELOS works by reducing bone breakdown and stimulating rebuilding of bone and therefore reduces the risk of fracture.
Croatian: PROTELOS djeluje tako da usporava razgradnju, a pospješuje ponovnu izgradnju kosti čime se smanjuje opasnost od prijeloma.
English: The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, PROTELOS should be administered in-between meals.
Croatian: Apsorpciju stroncijeva ranelata smanjuju hrana, mlijeko i mliječni proizvodi te se stoga PROTELOS mora uzimati između obroka.
English: What PROTELOS contains - The active substance is strontium ranelate.
Croatian: Što PROTELOS sadrži - Djelatna tvar je stroncijev ranelat.
English: Oral supplementation with vitamin D has no effect on strontium exposure.
Croatian: D za peroralnu primjenu ne utječu na izloženost stronciju.
English: • PROTELOS is contraindicated and must not be used in patients with : o Established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Croatian: • PROTELOS je kontraindiciran i ne smije se koristiti u bolesnika s : o Dokazanom, postojećom ili prethodnom ishemijskom bolesti srca, perifernom arterijskom bolesti i/ili cerebrovaskularnom bolesti u anamnezi.
English: If you are taking medicines containing calcium, you should leave at least 2 hours before you take PROTELOS.
Croatian: Uzimate li lijekove koji sadržavaju kalcij, PROTELOS smijete uzeti tek nakon što prođu najmanje dva sata od uzimanja tih lijekova.
English: No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Croatian: U bolesnika s oštećenom funkcijom jetre dozu ne treba prilagođavati (vidjeti dio 5.2).
English: However, it is recommended to drink the suspension immediately after preparation (see section 4.2) 6.4 Special precautions for storage
Croatian: Međutim, preporučuje se suspenziju popiti odmah nakon pripreme (vidjeti dio 4.2)
English: You should stop taking PROTELOS if you have to take oral tetracyclines such as doxycycline or quinolones such as ciprofloxacin (two types of antibiotics).
Croatian: Ako morate uzimati kroz usta tetracikline kao što je doksiciklin ili kinolone kao što je ciprofloksacin (dvije vrste antibiotika), morate prestati uzimati PROTELOS.
English: Servier Laboratories OÜ Tel:+ 372 664 5040
Croatian: Servier Laboratoires OÜ Tel : +372 664 040
English: No evidence of clinical interactions or relevant increase of blood strontium levels with medicinal products expected to be commonly prescribed concomitantly with PROTELOS in the target population were found during clinical trials.
Croatian: Tijekom kliničkih istraživanja nije bilo dokaza klinički značajnih interakcija, kao niti značajnog porasta razine stroncija u krvi pri istodobnom uzimanju lijekova za koje se očekivalo da će se u ciljne populacije često propisivati istodobno s PROTELOS-om.
English: The efficacy of PROTELOS was demonstrated in men with osteoporosis in a 2-year, doubleblind,placebo-controlled study with a main analysis after one year in 243 patients (Intention to treatpopulation, 161 patients received strontium ranelate) at high risk of fracture (mean age 72,7 years; mean lumbar BMD T-score value of -2.6; 28% of prevalent vertebral fracture).
Croatian: Djelotvornost PROTELOS-a je dokazana kod muškaraca s osteporozom u dvogodišnjem, dvostrukoslijepom, placebom kontroliranom ispitivanju s glavnom analizom provedenom nakon jedne godine na 243 ispitanika (ITT populacija, 161 ispitanik je primao stroncijev ranelat) s visokim rizikom od prijeloma (srednja dob 72,7 godina; srednja BMD T-vrijednost za lumbalnu kralježnicu -2,6%; prevalencija prijeloma kralježnice 28%).