natgillin/translations-raw huggingface dataset:
However, since this increase is within the normal variability of the bioavailability of ibandronic acid, no dose adjustment is considered necessary when Bondenza is administered with H2- antagonists or other active substances which increase gastric pH.
Ker je to zvečanje v mejah normalne variabilnosti biološke uporabnosti ibandronske kisline, pri sočasnem jemanju Bondenze s H2- antagonisti ali drugimi zdravili, ki zvečajo pH želodca, prilagajanje odmerkov ni potrebno.
Pharmacokinetic interaction studies in postmenopausal women have demonstrated the absence of any interaction potential with tamoxifen or hormone replacement therapy (oestrogen).
Farmakokinetične študije medsebojnega delovanja pri ženskah v postmenopavzi so pokazale, da s tamoksifenom ali hormonskim nadomestnim zdravljenjem (estrogenom) ne prihaja do medsebojnega delovanja.
4 4.6 Pregnancy and lactation
4 Pri bolnikih z multiplim mielomom, ki so sočasno jemali melfalan ali prednizolon, medsebojnega delovanja niso opazili.
Pregnancy There are no adequate data from the use of ibandronic acid in pregnant women.
Nosečnost Ni zadostnih podatkov o uporabi ibandronske kisline pri nosečnicah.
Studies in rats have shown some reproductive toxicity (see section 5.3).
Študije na podganah so pokazale določen vpliv na sposobnost razmnoževanja (glejte poglavje 5. 3).
Bondenza should not be used during pregnancy.
Zdravilo Bondenza se med nosečnostjo ne sme uporabljati.
Lactation It is not known whether ibandronic acid is excreted in human milk.
Dojenje Ni znano, ali se ibandronska kislina izloča v materino mleko.
Bondenza should not be used during lactation.
Zdravilo Bondenza se med dojenjem ne sme uporabljati.
The safety of ibandronic acid 2.5 mg daily was evaluated in 1251 patients treated in 4 placebo- controlled clinical studies; 73% of these patients came from the pivotal three-year treatment study (MF 4411).
Varnost ibandronske kisline 2, 5 mg enkrat na dan so proučevali v 4 s placebom kontroliranih kliničnih študijah pri 1251 bolnikih; 73% teh bolnikov je sodelovalo v ključni triletni študiji (MF 4411).
The overall safety profile of ibandronic acid 2.5 mg daily in all these studies was similar to that of placebo.
Celoten varnostni profil ibandronske kisline 2, 5 mg enkrat na dan je bil v vseh teh študijah podoben kakor pri placebu.
The overall proportion of patients who experienced an adverse reaction, i. e. adverse event with a possible or probable relationship to trial medication, in the pivotal treatment study (MF 4411) was 19.8% for ibandronic acid and 17.9% for placebo.
Celoten delež bolnikov, pri katerih se je pojavil neželeni učinek, to je neželeni dogodek z možno ali verjetno povezavo z zdravilom v preskušanju, je v ključni študiji zdravljenja (MF 4411) za ibandronsko kislino znašal 19, 8%, za placebo pa 17, 9%.
In a two-year study in postmenopausal women with osteoporosis (BM 16549) the overall safety of Bondenza 150 mg once monthly and ibandronic acid 2.5 mg daily was similar.
V dveletni študiji pri ženskah z osteoporozo v postmenopavzi (BM 16549) je bila celokupna varnost Bondenze 150 mg enkrat na mesec in ibandronske kisline 2, 5 mg enkrat na dan podobna.
The overall proportion of patients who experienced an adverse reaction, was 22.7% and 25.0% for Bondenza 150 mg once monthly and 21.5% and 22.5% for ibandronic acid 2.5 mg daily after one and two years, respectively.
Celoten delež bolnikov, ki so imeli neželeni učinek, je bil 22, 7% za Bondenzo 150 mg enkrat na mesec po enem letu in 25, 0% po dveh letih ter 21, 5% za ibandronsko kislino 2, 5 mg enkrat na dan po enem letu in 22, 5% po dveh letih.
The majority of adverse reactions were mild to moderate in intensity.
Večina neželenih učinkov je bila glede na jakost blaga do zmerna.
Most cases did not lead to cessation of therapy.
V večini primerov prekinitev terapije ni bila potrebna.
Table 1 and table 2 list adverse reactions occurring in more than 1% of patients treated with Bondenza 150 mg monthly or 2.5 mg daily in study BM 16549 and in patients treated with ibandronic acid 2.5 mg daily in study MF 4411.
Preglednica 1 in preglednica 2 prikazujeta neželene učinke, ki so se pojavili pri več kot 1% bolnikov, ki so se zdravili z Bondenzo 150 mg enkrat na mesec ali 2, 5 mg enkrat na dan v študiji BM 16549 in pri bolnikih, zdravljenih z ibandronsko kislino 2, 5 mg enkrat na dan v študiji MF 4411.
The tables show the adverse reactions in the two studies that occurred with a higher incidence than in patients treated with placebo in study MF 4411.
Preglednici prikazujeta neželene učinke v teh dveh študijah, ki so se pojavili z večjo incidenco kakor pri bolnikih, ki so v študiji MF 4411 prejemali placebo.
Data at one year from BM 16549 are represented in Table 1 and cumulative data for the two years from BM 16549 are represented in table 2.
Podatki po enem letu iz BM 16549 so prikazani v preglednici 1, združeni podatki dveh let iz BM 16549 so prikazani v preglednici 2.
Table 1:
5 Preglednica 1.
Common adverse reactions (> 1/ 100, ≤ 1/ 10) in phase III osteoporosis studies that were considered by the investigator to be possibly or probably related to treatment - One year data from study BM 16549 and three year data from placebo-controlled fracture study MF 4411
Pogosti neželeni učinki (> 1/ 100, ≤ 1/ 10) v fazi III študij pri osteoporozi, za katere je raziskovalec menil, da so možno ali verjetno povezani z zdravljenjem – enoletni podatki iz študije BM 16549 in triletni podatki iz MF 4411, s placebom primerjane študije, v kateri so proučevali učinkovitost proti zlomom.
One year data in study BM 16549
Enoletni podatki iz 16549
Three year data in study MF 4411
Triletni podatki iz študije MF 4411
System Organ Class/ Adverse reaction Gastrointestinal system
Organski sistem / neželeni učinek Prebavila
Bondenza 150 mg ibandronic acid once monthly 2.5 mg daily (N=396) (N=395) (%) (%)
Bondenza 150 mg enkrat na mesec (n = 396) (%)
ibandronic acid Placebo 2.5 mg daily (N=975) (N=977) (%) (%)
ibandronska kislina 2, 5 mg enkrat na dan (n = 395) (%)
Gastro-oesophageal reflux disease
ibandronska placebo kislina 2, 5 mg (n = 975) enkrat na dan (%) (n = 977) (%)
Diarrhoea
gastroezofagealna refluksna bolezen
One year data in study BM 16549
1, 0
Three year data in study MF 4411
0, 4 0, 1
Bondenza 150 mg ibandronic acid once monthly 2.5 mg daily (N=396) (N=395) (%) (%)
diareja abdominalna bolečina dispepsija navzea flatulenca Živčevje
ibandronic acid Placebo 2.5 mg daily (N=975) (N=977) (%) (%)
2, 5 3, 5 3, 3 3, 3 0, 5
3.5 2.8 3.3 5.8 3.3 3.5 0.5 1.0
1, 8 2, 8 5, 8 3, 5 1, 0
Headache General disorders
glavobol Splošne težave
0.8 1.5
0, 8
Influenza like illness* Fatigue Musculoskeletal system
bolezen, podobna gripi * utrujenost Mišično- skeletni sistem
3.3 0.3 1.0 0.3
0, 3 0, 3
Arthralgia Myalgia Skin disorders
artralgija mialgija Bolezni kože
1.0 0.3 1.5 0.3
0, 3 0, 3
Rash MedDRA version 6.1
izpuščaj MedDRA verzija 6. 1
0.8 1.0
0, 8
* Transient, influenza-like symptoms have been reported with Bondenza 150 mg once monthly, typically in association with the first dose.
* Prehodni, gripi podobni simptomi, o katerih so poročali pri jemanju Bondenze 150 mg enkrat na mesec, značilno v povezavi s prvim odmerkom.
Such symptoms were generally of short duration, mild or moderate in intensity, and resolved during continuing treatment without requiring remedial measures.
Taki simptomi so bili navadno kratkotrajni, blagi do zmerno močni, z nadaljevanjem zdravljenja so izginili brez posegov v samo zdravljenje.
Cumulative common adverse reactions (> 1/ 100, ≤ 1/ 10) in Phase III osteoporosis studies that were considered by the investigator to be possibly or probably related to treatment - Two year data from study BM 16549 and three year data from placebo-controlled fracture study MF 4411
Kumulativni pogosti neželeni učinki (> 1/ 100, ≤ 1/ 10) v fazi III študij pri osteoporozi, za katere je raziskovalec menil, da so možno ali verjetno povezani z zdravljenjem – dveletni podatki iz študije BM 16549 in triletni podatki iz MF 4411, s placebom primerjane študije, v kateri so proučevali učinkovitost proti zlomom.
Two year cumulative data in study BM 16549
Dveletni kumulativni podatki iz študije BM 16549
Bondenza 150 mg ibandronic acid once monthly 2.5 mg daily (N=396) (N=395) (%) (%)
Bondenza ibandronska 150 mg enkrat kislina 2, 5 mg na mesec enkrat na dan (n = 396) (n = 395) (%) (%)
ibandronic acid Placebo 2.5 mg daily (N=975) (N=977) (%) (%)
ibandronska placebo kislina 2, 5 mg (n = 975) enkrat na dan (%) (n = 977) (%)
Gastritis Gastro-oesophageal reflux disease
gastritis gastroezofagealna refluksna bolezen
1.0 0.3 0.8 1.0
0, 5 0, 3 0, 8 1, 0
0.3 0.2
ezofagitis
0.1 0.4 0 0 0.4 0.4
0 1, 0
Two year cumulative data in study BM 16549
Dveletni kumulativni podatki iz študije BM 16549 ibandronska
Three year data in study MF 4411
Triletni podatki iz študije MF 4411 placebo ibandronska
System Organ Class/ Adverse reaction
neželeni učinek
Bondenza 150 mg ibandronic acid once monthly 2.5 mg daily (N=396) (N=395) (%) (%)
150 mg enkrat enkrat na dan na mesec (n = 395) (n = 396) (%) (%)
ibandronic acid Placebo 2.5 mg daily (N=975) (N=977) (%) (%)
(%) enkrat na dan (n = 977) (%)
Myalgia Musculoskeletal stiffness Skin disorders
artralgija mialgija mišičnoskeletna otrplost Bolezni kože
Rash MedDRA version 7.1
izpuščaj MedDRA verzija 7. 1
Adverse reactions occurring at a frequency of less than or equal to 1%
Neželeni učinki, ki so se pojavili s pogostnostjo, manjšo kot ali enako 1%
The following list provides information on adverse reactions reported in study MF 4411 occurring more frequently with ibandronic acid 2.5 mg daily than with placebo and study BM 16549 occurring more frequently with Bondenza 150 mg once monthly than with ibandronic acid 2.5 mg daily.
Spodaj navedeni neželeni učinki so se v študiji MF 4411 pojavili pogosteje pri ibandronski kislini 2, 5 mg enkrat na dan kot pri placebu in v študiji BM 16549 pogosteje pri zdravilu Bondenza 150 mg enkrat na mesec kot pri ibandronski kislini 2, 5 mg enkrat na dan.
Uncommon (1/ 100 – 1/ 1,000) Gastro-intestinal Disorders:
Občasni (1/ 100 – 1/ 1. 000) Bolezni prebavil:
gastritis, oesophagitis including oesophageal ulcerations or strictures, vomiting, dysphagia
gastritis, ezofagitis, vključno z ezofagealnimi ulceracijami ali zožitvami, bruhanje, disfagija.
Nervous System Disorders:
Bolezni živčevja:
Musculoskeletal and Connective Tissue Disorders:
Bolezni mišično- skeletnega sistema in vezivnega tkiva:
dizziness back pain
omotica. bolečina v hrbtu.
Rare (1/ 1,000 – 1/ 10,000)
Redki (1/ 1. 000 – 1/ 10. 000)
Gastro-intestinal Disorders:
Bolezni prebavil:
Immune System Disorders:
Bolezni imunskega sistema:
Skin and Subcutaneous Tissue Disorders:
Bolezni kože in podkožja:
duodenitis hypersensitivity reactions angioedema, face oedema, urticaria
duodenitis. preobčutljivostne reakcije. angioedem, edem obraza, koprivnica.
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.
Bolniki z anamnezo bolezni prebavil, vključno s peptično razjedo brez nedavne krvavitve ali hospitalizacije, dispepsijo ali refluksom, urejenim z zdravili, so bili vključeni v študijo z odmerjanjem
For these patients, there was no difference in the incidence of upper gastrointestinal adverse events with the 150 mg once monthly regimen compared to the 2.5 mg daily regimen.
Razlik v incidenci neželenih učinkov v zgornjem delu prebavil pri teh bolnikih glede na jemanje 150 mg enkrat na mesec ali 2, 5 mg enkrat na dan ni bilo.
Laboratory test findings In the pivotal three-year study with ibandronic acid 2.5 mg daily (MF 4411) there was no difference compared with placebo for laboratory abnormalities indicative of hepatic or renal dysfunction, an impaired haematologic system, hypocalcaemia or hypophosphataemia.
Izvidi laboratorijskih preiskav V ključni triletni študiji z ibandronsko kislino 2, 5 mg enkrat na dan (MF 4411) v primerjavi s placebom niso ugotovili razlik v laboratorijskih patoloških vrednostih, ki bi kazale na jetrno ali ledvično disfunkcijo, motnje hematološkega sistema, hipokalcemijo ali hipofosfatemijo.
Similarly, no differences were noted between the groups in study BM 16549 after one and two years.
Tudi v študiji BM 16549 po enem ali dveh letih razlik med skupinama niso opazili.
Post-marketing Experience Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
Postmarketinške izkušnje Pri bolnikih, zdravljenih z bisfosfonati, so poročali o osteonekrozi čeljusti.
Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis).
Osteonekroza čeljusti je navadno povezana z izdrtjem zoba ali lokalno okužbo (vključno z osteomielitisom) ali obojim.
Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4).
Rak, kemoterapija, radioterapija, kortikosteroidi in slaba ustna higiena se prav tako štejejo za dejavnike tveganja (glejte poglavje 4. 4).
7 4.9 Overdose
4. 9 Preveliko odmerjanje
No specific information is available on the treatment of over dosage with Bondenza.
Specifičnih informacij o zdravljenju prevelikega odmerjanja zdravila Bondenza ni na voljo.
However, based on a knowledge of this class of compounds, oral over-dosage may result in upper gastrointestinal adverse reactions (such as upset stomach, dyspepsia, oesophagitis, gastritis, or ulcer) or hypocalcaemia.
Glede na podatke o tej skupini zdravil lahko preveliko peroralno odmerjanje povzroči neželene učinke v zgornjem delu prebavil (kot so razdražen želodec, dispepsija, ezofagitis, gastritis ali razjeda) ali hipokalcemijo.
Milk or antacids should be given to bind Bondenza, and any adverse reactions treated symptomatically.
Za vezavo Bondenze je treba zaužiti mleko ali antacide, neželene učinke pa zdravimo simptomatično.
Pharmacotherapeutic group:
Farmakoterapevtska skupina: difosfonati.
Bisphosphonates, ATC code:
Oznaka ATC:
Mechanism of action Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act selectively on bone tissue and specifically inhibit osteoclast activity without directly affecting bone formation.
Mehanizem delovanja Ibandronska kislina je visoko učinkovit bisfosfonat iz skupine dušik vsebujočih bisfosfonatov, ki selektivno delujejo na kostno tkivo in specifično zavirajo osteoklastno aktivnost brez neposrednega vpliva na proces tvorbe kosti.
Pharmacodynamic effects The pharmacodynamic action of ibandronic acid is inhibition of bone resorption.
Farmakodinamski učinki Farmakodinamski učinek ibandronske kisline je zaviranje resorpcije kosti.
In growing rats, there was no evidence of impaired mineralization even at doses greater than 5,000 times the dose required for osteoporosis treatment.
Pri rastočih podganah niso našli dokazov o motnji mineralizacije tudi pri odmerkih, ki so bili 5. 000- krat večji od odmerkov, potrebnih za zdravljenje osteoporoze.
In humans, the efficacy of both daily and intermittent administration with a dose-free interval of 9-10 weeks of ibandronic acid was confirmed in a clinical trial (MF 4411), in which ibandronic acid demonstrated anti-fracture efficacy.
Pri ljudeh je bila učinkovitost tako dnevnega kot intermitentnega dajanja ibandronske kisline z 9 - do 10- tedenskim premorom brez odmerka potrjena v kliničnem preskušanju (MF 4411), v katerem je ibandronska kislina dokazala učinkovitost proti zlomom.
In animal models ibandronic acid produced biochemical changes indicative of dose-dependent inhibition of bone resorption, including suppression of urinary biochemical markers of bone collagen degradation (such as deoxypyridinoline, and cross-linked N-telopeptides of type I collagen (NTX)).
8 Pri živalskih modelih je ibandronska kislina povzročila biokemične spremembe, ki kažejo na od odmerka odvisno zaviranje resorpcije kosti, vključno s supresijo urinarnih biokemičnih označevalcev razgradnje kostnega kolagena (kot so deoksipiridinolin in navzkrižni N- telopeptidi kolagena tipa I (NTX)).
In a Phase 1 bioequivalence study conducted in 72 postmenopausal women receiving 150 mg orally every 28 days for a total of four doses, inhibition in serum CTX following the first dose was seen as early as 24 hours post-dose (median inhibition 28%), with median maximal inhibition (69%) seen 6 days later.
V fazi I bioekvivalenčne študije pri 72 ženskah v postmenopavzi, ki so prejemale 150 mg peroralno vsakih 28 dni, skupno štiri odmerke, je bila inhibicija serumskega CTX po prvem odmerku opazna že 24 ur po odmerku (mediana inhibicije 28%) z mediano maksimalne inhibicije (69%), opaženo 6 dni pozneje.
Following the third and fourth dose, the median maximum inhibition 6 days post dose was 74% with reduction to a median inhibition of 56% seen 28 days following the fourth dose.
Po tretjem in četrtem odmerku je bila mediana maksimalne inhibicije 6 dni po odmerku 74% z zmanjšanjem na mediano inhibicije 56% po 28 dneh po četrtem odmerku.
Clinical efficacy Independent risk factors, for example, low BMD, age, the existence of previous fractures, a family history of fractures, high bone turnover and low body mass index should be considered in order to identify women at increased risk of osteoporotic fractures.
Klinična učinkovitost Pri prepoznavanju žensk s povečanim tveganjem za osteoporotični zlom moramo upoštevati neodvisne dejavnike tveganja, kot so na primer nizka mineralna kostna gostota, starost, obstoj predhodnih zlomov, družinska obremenjenost z zlomi, visoko razmerje med razgradnjo in tvorbo kosti in nizek indeks telesne mase.
8 Bone mineral density (BMD) Bondenza 150 mg once monthly was shown to be at least as effective as ibandronic acid 2.5 mg daily at increasing BMD in a two year, double-blind, multicentre study (BM 16549) of postmenopausal women with osteoporosis (lumbar spine BMD T score below -2.5 SD at baseline).
Mineralna kostna gostota (MKG) Bondenza 150 mg enkrat na mesec se je v povišanju MKG izkazala za najmanj enako učinkovito kakor ibandronska kislina 2, 5 mg enkrat na dan v dveletni dvojno slepi, multicentrični študiji (BM 16549) pri ženskah z osteoporozo v postmenopavzi (izhodiščna T- vrednost MKG ledvene hrbtenice pod – 2, 5 SD).
This was demonstrated in both the primary analysis at one year and in the confirmatory analysis at two years endpoint (Table 3).
To je bilo dokazano v primarni analizi po enem letu in v potrditveni analizi v končni točki po dveh letih (Preglednica 3).
One year data in study BM 16549
Povprečna relativna sprememba od izhodiščne vrednosti MKG ledvene hrbtenice, kolka, femoralnega vratu in trohantra po enem letu (primarna analiza) in dveh letih zdravljenja (populacija po protokolu) v študiji BM 16549.
Two year data in study BM 16549
Dveletni podatki iz študije Enoletni podatki iz študije BM BM 16549 16549
Mean relative changes from baseline% [95% CI]
Povprečna relativna sprememba od izhodiščne vrednosti% [95 -% interval zaupanja]
ibandronic acid Bondenza 2.5 mg daily 150 mg once (N=318) monthly (N=320)
ibandronska kislina 2, 5 mg enkrat na dan
ibandronic acid Bondenza 2.5 mg daily 150 mg once (N=294) monthly (N=291)
Bondenza 150 mg enkrat na mesec
Lumbar spine L2-L4 BMD
ibandronska kislina 2, 5 mg enkrat na dan
3.9 [3.4, 4.3] 4.9 [4.4, 5.3]
3, 9 [3, 4; 4, 3]
5.0 [4.4, 5.5] 6.6 [6.0, 7.1]
4, 9 [4, 4; 5, 3]
Total hip BMD
5, 0 [4, 4; 5, 5]
2.0 [1.7, 2.3]
2, 0 [1, 7; 2, 3]
3.1 [2.8, 3.4]
3, 1 [2, 8; 3, 4]
2.5 [2.1, 2.9]
2, 5 [2, 1; 2, 9]
4.2 [3.8, 4.5]
4, 2 [3, 8; 4, 5]
1.7 [1.3, 2.1]
1, 7 [1, 3; 2, 1]
2.2 [1.9, 2.6]
2, 2 [1, 9; 2, 6]
1.9 [1.4, 2.4]
1, 9 [1, 4; 2, 4]
3.1 [2.7, 3.6]
3, 1 [2, 7; 3, 6]
3.2 [2.8, 3.7]
3, 2 [2, 8; 3, 7]
Furthermore, Bondenza 150 mg once monthly was proven superior to ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p=0.002, and at two years, p < 0.001.
Zdravilo Bondenza 150 mg enkrat na mesec se je izkazalo za boljše kakor ibandronska kislina 2, 5 mg enkrat na dan v povišanju MKG ledvene hrbtenice v prospektivno načrtovani analizi po enem letu, p = 0, 002, in dveh letih, p < 0, 001.
At one year (primary analysis), 91.3% (p=0.005) of patients receiving Bondenza 150 mg once monthly had a lumbar spine BMD increase above or equal to baseline (BMD responders), compared with 84.0% of patients receiving ibandronic acid 2.5 mg daily.
Po enem letu (primarna analiza) se je 91, 3% (p = 0, 005) bolnikom, ki so prejemali Bondenzo 150 mg enkrat na mesec, MKG lumbalne hrbtenice povišala ali ostala enaka izhodiščni vrednosti (bolniki, odzivni na povišanje MKG) v primerjavi s 84, 0% bolnikov, ki so prejemali ibandronsko kislino
At two years, 93.5% (p=0.004) and 86.4% of patients receiving Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders.
Po dveh letih je bilo odzivnih 93, 5% bolnikov (p = 0, 004), ki so prejemali Bondenzo 150 mg enkrat na mesec in 86, 4% bolnikov, ki so prejemali ibandronsko kislino 2, 5 mg enkrat na dan.
For total hip BMD, 90.0% (p < 0.001) of patients receiving Bondenza 150 mg once monthly and 76.7% of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline at one year.
MKG kolka se je po enem letu povišala ali ostala enaka izhodiščni vrednosti pri 90, 0% (p < 0, 001) bolnikov, ki so prejemali 150 mg enkrat na mesec in 76, 7% bolnikov, ki so prejemali ibandronsko kislino 2, 5 mg na dan.
At two years 93.4% (p < 0.001) of patients receiving Bondenza 150 mg once monthly and 78.4%, of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline.
Po dveh letih se je MKG kolka povišala ali ostala enaka izhodiščni vrednosti pri 93, 4% bolnikov (p < 0, 001), ki so prejemali Bondenzo 150 mg enkrat na mesec in 78, 4% bolnikov, ki so prejemali ibandronsko kislino 2, 5 mg enkrat na dan.
When a more stringent criterion is considered, which combines both lumbar spine and total hip BMD, 83.9% (p < 0.001) and 65.7% of patients receiving Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders at one year.
Če upoštevamo strožji kriterij, ki združuje MKG ledvene hrbtenice in kolka, je bilo po enem letu odzivnih 83, 9% (p < 0, 001) bolnikov, ki so prejemali zdravilo Bondenza 150 mg enkrat na mesec in 65, 7% bolnikov, ki so prejemali ibandronsko kislino 2, 5 mg na dan.
At two years, 87.1% (p < 0.001) and 70.5%, of patients met this criterion in the 150 mg monthly and 2.5 mg daily arms respectively.
Po dveh letih je 87, 1% (p < 0, 001) bolnikov, ki so prejemali 150 mg enkrat na mesec in 70, 5% bolnikov, ki so prejemali 2, 5 mg na dan, zadostilo kriterijem za odzivnost.
Biochemical markers of bone turn-over Clinically meaningful reductions in serum CTX levels were observed at all time points measured, i. e. months 3, 6, 12 and 24.
Biokemični označevalci kostne premene Klinično pomembno zmanjšanje serumskih vrednosti CTX so opazili ob merjenju v vseh časovnih obdobjih, to je po 3., 6., 12. in 24. mesecih.
After one year (primary analysis) the median relative change from baseline was -76% for Bondenza 150 mg once monthly and -67% for ibandronic acid 2.5 mg daily.
Po enem letu (primarna analiza) je bila mediana relativne spremembe od izhodiščne vrednosti – 76% za Bondenzo 150 mg enkrat na mesec in – 67% za ibandronsko kislino 2, 5 mg enkrat na dan.
At two years the median relative change was -68% and -62%, in the 150 mg monthly and 2.5 mg daily arms respectively.
Po dveh letih je bila mediana relativne spremembe – 68% za mesečno odmerjanje 150 mg in – 62% za dnevno odmerjanje 2, 5 mg.
At one year, 83.5% (p= 0.006) of patients receiving Bondenza 150 mg once monthly and 73.9% of patients receiving ibandronic acid 2.5 mg daily were identified as responders (defined as a decrease
Po enem letu je bilo odzivnih 83, 5% bolnikov (p = 0, 006), ki so prejemali Bondenzo 150 mg enkrat na mesec in 73, 9% bolnikov, ki so jemali ibandronsko kislino 2, 5 mg enkrat na dan, odzivnost so definirali kot ≥ 50% zmanjšanje od izhodišča.