natgillin/translations-raw huggingface dataset:
In the pivotal two-year study in postmenopausal women with osteoporosis (BM16550), the overall safety of intravenous injection of Bondenza 3 mg every 3 months and oral ibandronic acid 2.5 mg daily were shown to be similar.
V ključni dveletni študiji pri ženskah z osteoporozo v postmenopavzi (BM 16550), je bila celokupna varnost zdravila Bondenza 3 mg v obliki intravenske injekcije, dane vsake 3 mesece, in ibandronske kisline 2, 5 mg, dane peroralno enkrat na dan, podobna.
The overall proportion of patients who experienced an adverse reaction was 26.0% and 28.6% for Bondenza 3 mg injection every 3 months and 20.4% and 22.6% for oral ibandronic acid 2.5 mg daily after one year and two years, respectively.
Celoten delež bolnikov, ki so imeli neželeni učinek, je bil 26, 0% za zdravilo Bondenza 3 mg v obliki injekcije, dane vsake 3 mesece, po enem letu in 28, 6% po dveh letih; 20, 4% za 2, 5 mg ibandronske kisline, dane peroralno enkrat na dan, po enem letu in 22, 6% po dveh letih.
Table 1 and table 2 list adverse events after one year and two years of treatment, respectively, from the pivotal phase III trial BM16550, reported as possibly or probably related to trial medicinal product, in more than 1% of the patients treated with either intravenous injection of Bondenza 3 mg every 3 months or intravenous injection of placebo plus oral ibandronic acid 2.5 mg daily.
Preglednici 1 in 2 prikazujeta neželene dogodke po enem in dveh letih zdravljenja iz ključne faze III preskušanja BM 16550, o katerih so poročali, da so možno ali verjetno povezani z zdravilom v preskušanju pri več kot 1% bolnikov, ki so se zdravili z intravensko injekcijo Bondenze 3 mg vsake 3 mesece ali intravensko injekcijo placeba z 2, 5 mg ibandronske kisline, dane peroralno enkrat na dan.
Adverse reactions reported in patients treated with Bondenza 3 mg injection at a frequency equal to or less than that in orally treated patients, are not included.
Neželeni učinki, o katerih so poročali enako pogosto ali redkeje pri bolnikih, zdravljenih s 3- mg injekcijami Bondenze kakor pri peroralnem odmerjanju, niso upoštevani.
Tables 1 and 2 also show adverse reactions in patients treated for 3 years with oral ibandronic acid 2.5 mg daily in the anti-fracture study (MF4411).
Preglednici 1 in 2 prikazujeta tudi neželene učinke pri bolnikih, ki so se v okviru študije, v kateri so proučevali
For both studies, adverse reactions are listed which occurred with a higher incidence in ibandronic acid -treated
18 učinkovitost proti zlomom (MF 4411), 3 leta zdravili z ibandronsko kislino 2, 5 mg na dan peroralno.
17 patients compared with the placebo-treated patients of study MF4411.
Za obe študiji so navedeni neželeni učinki, ki so se pojavili z večjo incidenco pri bolnikih, zdravljenih z ibandronsko kislino, kakor pri bolnikih, zdravljenih s placebom v študiji MF 4411.
Common adverse reactions (> 1/ 100, ≤ 1/ 10) in the phase III osteoporosis study BM16550 after one year of treatment and in the phase III anti-fracture study MF 4411 (three-year study), that were considered by the investigator to be possibly or probably related to study medicinal product.
Pogosti neželeni učinki (> 1/ 100, ≤ 1/ 10) v fazi III študije pri osteoporozi BM 16550 po enem letu zdravljenja in v fazi III študije, ki je proučevala učinkovitost proti zlomom MF 4411 (triletna študija), za katere je raziskovalec menil, da so možno ali verjetno povezani z zdravilom v preskušanju.
16550
Enoletni podatki iz študije BM 16550
Three year data in 4411
Triletni podatki iz študije MF 4411
study MF
Bondenza 3 mg v
System Organ Class/ Adverse reaction Gastrointestinal disorders
/ neželeni učinek
Bondenza injection 3 mg every 3 months (N=469) ADR No.
obliki injekcije
Placebo injection + oral ibandronic acid 2.5 mg daily (N=465) ADR No.
enkrat na dan
(%)
enkrat na dan peroralno
Placebo (N=975) ADR No.
peroralno (n = 977)
Gastritis Diarrhoea Abdominal pain Dyspepsia Nausea Constipation Musculoskeletal disorders
abdominalna bolečina dispepsija navzea zaprtje Bolezni mišično - skeletnega sistema
5 (1.1) 5 (1.1) 13 (2.8) 12 (2.6) 8 (1.7) 5 (1.1)
13 (2, 8) 12 (2, 6) 8 (1, 7) 5 (1, 1)
4 (0.9) 2 (0.4) 15 (3.2) 18 (3.9) 12 (2.6) 7 (1.5)
15 (3, 2) 18 (3, 9) 12 (2, 6) 7 (1, 5)
7 (0.7) 14 (1.4) 21 (2.1) 40 (4.1) 18 (1.8) 3 (0.3)
21 (2, 1) 40 (4, 1) 18 (1, 8) 3 (0, 3)
5 (0.5) 10 (1.0) 28 (2.9) 26 (2.7) 22 (2.3) 9 (0.9)
28 (2, 9) 26 (2, 7) 22 (2, 3) 9 (0, 9)
Musculo-skeletal pain
mišično- skeletna bolečina
Arthralgia Myalgia General System disorders
artralgija mialgija Splošne težave
11 (2.3) 8 (1.7)
11 (2, 3) 8 (1, 7)
4 (0.4) 18 (1.8)
4 (0, 4) 18 (1, 8)
4 (0.4) 8 (0.8)
4 (0, 4) 8 (0, 8)
Influenza-like illness*
bolezen, podobna gripi *
Fatigue Nervous System disorders
utrujenost Bolezni živčevja
Headache Skin disorders
glavobol Bolezni kože
Rash MedDRA version 7.0
izpuščaj MedDRA verzija 7. 0
* Transient, influenza-like symptoms have been reported in patients receiving intravenous injection of Bondenza 3 mg every 3 months, typically in association with the first dose.
* Prehodni, gripi podobni simptomi, o katerih so poročali pri uporabi intravenske injekcije zdravila Bondenza 3 mg, dani vsake 3 mesece, značilno v povezavi s prvim odmerkom.
18 Table 2:
19 Preglednica 2.
Common adverse reactions (> 1/ 100, ≤ 1/ 10) in the phase III osteoporosis study BM16550 after two years of treatment (cumulative data) and in the phase III anti-fracture study MF 4411 (three- year study), that were considered by the investigator to be possibly or probably related to study medicinal product.
Pogosti neželeni učinki (> 1/ 100, ≤ 1/ 10) v fazi III študije pri osteoporozi BM 16550 po dveh letih zdravljenja (kumulativni podatki) in v fazi III študije, ki je proučevala učinkovitost proti zlomom MF 4411 (triletna študija), za katere je raziskovalec menil, da so možno ali verjetno povezani z zdravilom v preskušanju.
(%) ADR No.
ibandronska
Oral ibandronic acid 2.5 mg daily (N=977) ADR No.
kislina 2, 5 mg
6 (1.3) 4 (0.9) 5 (1.1) 3 (0.6) 17 (3.6) 21 (4.5) 14 (3.0) 19 (4.1) 8 (1.7) 13 (2.8) 5 (1.1) 7 (1.5)
17 (3, 6) 14 (3, 0) 8 (1, 7) 5 (1, 1)
Arthralgia Myalgia Back pain General System disorders
artralgija mialgija bolečina v hrbtu Splošne težave
13 (2.8) 4 (0.9) 8 (1.7) 4 (0.9) 5 (1.1) 1 (0.2)
13 (2, 8) 8 (1, 7) 5 (1, 1)
4 (0.4) 18 (1.8) 3 (0.3)
4 (0, 4) 18 (1, 8) 3 (0, 3)
4 (0.4) 8 (0.8) 2 (0.2)
4 (0, 4) 8 (0, 8) 2 (0, 2)
2 (0.2)
2 (0, 4)
Rash MedDRA version 8.0
izpuščaj MedDRA verzija 8. 0
* Transient, influenza-like symptoms have been reported in patients receiving intravenous injection of Bondenza 3 mg every 3 months, typically in association with the first dose.
* Prehodni, gripi podobni simptomi, o katerih so poročali pri uporabi intravenske injekcije Bondenze 3 mg, dani vsake 3 mesece, značilno v povezavi s prvim odmerkom.
Adverse reactions occurring at a frequency of ≤ 1% in study BM16650:
Neželeni učinki, ki so se pojavili s pogostnostjo ≤ 1% v študiji BM 16650:
Uncommon (> 1/ 1,000 and < 1/ 100) Musculoskeletal disorders
Občasni (> 1/ 1. 000 in < 1/ 100) Bolezni mišično- skeletnega sistema:
Asthenia Injection site reactions
astenija reakcije na mestu injiciranja
19 Vascular Disorders
Žilne bolezni:
Rare (> 1/ 10,000 and < 1/ 1,000)
20 Redki (> 1/ 10. 000 in < 1/ 1. 000) Bolezni imunskega sistema:
Immune system disorders:
Bolezni kože in podkožja:
Skin and subcutaneous tissue disorders:
preobčutljivostne reakcije angioedem otekanje obraza/ edem urtikarija
Hypersensitivity reactions Angioedema Facial swelling/ oedema Urticaria
Izvidi laboratorijskih preiskav
Laboratory test findings In the pivotal three-year study with oral ibandronic acid 2.5 mg daily (MF 4411) there was no difference compared with placebo for laboratory abnormalities indicative of hepatic or renal dysfunction, impaired haematologic system, hypocalcaemia or hypophosphataemia.
V ključni triletni študiji s peroralnim odmerjanjem 2, 5 mg ibandronske kisline 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 the pivotal study with Bondenza 3 mg injection every 3 months (BM 16550).
Tudi v ključni študiji s 3- mg injekcijo Bondenze, dano vsake 3 mesece (BM 16550) razlik med skupinama niso opazili.
No specific information is available on the treatment of overdosage with Bondenza.
Specifičnih informacij o zdravljenju prevelikega odmerjanja Bondenze ni na voljo.
In growing rats, there was no evidence of impaired mineralisation 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.
Both daily and intermittent (with prolonged dose-free intervals) long-term administration in rats, dogs and monkeys was associated with formation of new bone of normal quality and maintained or
Dnevno in intermitentno (s podaljšanimi premori brez odmerkov) dolgotrajno dajanje zdravila podganam, psom in opicam je bilo povezano s tvorbo nove kosti normalne kakovosti, mehanska moč
20 increased mechanical strength even at doses in the toxic range.
21 pa je bila ohranjena ali celo povečana tudi pri toksičnih odmerkih.
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 dnevnega in tudi 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)).
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)).
Both daily, intermittent (with a dose-free interval of 9 - 10 weeks per quarter) oral doses as well as intravenous doses of ibandronic acid in postmenopausal women produced biochemical changes indicative of dose-dependent inhibition of bone resorption.
Dnevno in intermitento (z 9 - do 10- tedenskimi premori brez odmerkov na četrtletje) dajanje peroralnih odmerkov, kot tudi intravensko dajanje ibandronske kisline, je pri ženskah v postmenopavzi sprožilo biokemične spremembe, ki kažejo na od odmerka odvisno inhibicijo resorpcije kosti.
Bondenza intravenous injection decreased levels of serum C-telopeptide of the alpha chain of Type I collagen (CTX) within 3 - 7 days of starting treatment and decreased levels of osteocalcin within 3 months.
Intravenske injekcije Bondenze so zmanjšale vrednosti serumskih C- telopeptidov alfa verige kolagena tipa I (CTX) v 3 do 7 dneh po začetku zdravljenja in vrednosti osteokalcina v 3 mesecih.
The histological analysis of bone biopsies after two and three years of treatment of postmenopausal women with doses of oral ibandronic acid 2.5 mg daily and intermittent intravenous doses of up to 1 mg every 3 months showed bone of normal quality and no indication of a mineralisation defect.
Histološka analiza biopsij kosti po dveh in treh letih zdravljenja žensk v postmenopavzi s peroralnimi 2, 5- mg odmerki ibandronske kisline enkrat na dan in intermitentnimi intravenskimi odmerki do 1 mg vsake 3 mesece, je pokazala normalno kakovost kosti brez znakov motenj mineralizacije.
An expected decrease in bone turnover, normal quality of bone and absence of defects in mineralization were also seen after two years of treatment with Bondenza 3 mg injection.
Tudi dveletno zdravljenje s 3- mg injekcijo Bondenze je pokazalo pričakovano zmanjšanje kostne premene, normalno kakovost kosti in odsotnost motenj mineralizacije.
Bondenza 3 mg intravenous injection, administered every 3 months, was shown to be at least as effective as oral ibandronic acid 2.5 mg daily in a 2-year, randomised, double-blind, multicentre, non- inferiority study (BM16550) of postmenopausal women (1386 women aged 55 - 80) with osteoporosis (lumbar spine BMD T-score below -2.5 SD at baseline).
Bondenza v obliki 3- mg intravenske injekcije, ki se daje vsake 3 mesece, se je izkazala za najmanj enako učinkovito kakor ibandronska kislina 2, 5 mg enkrat na dan peroralno v dveletni randomizirani, dvojno slepi, multicentrični, neinferiorni študiji (BM 16550) pri ženskah z osteoporozo v postmenopavzi (1386 žensk, starih 55 do 80 let z izhodiščno T- vrednostjo 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).
The primary analysis of data from study BM16550 at one year and the confirmatory analysis at 2 years demonstrated the non-inferiority of 3 mg every 3 months injection dosing regimen compared to 2.5 mg oral daily dosing regimen, in terms of mean increases in BMD at lumbar spine, total hip, femoral neck and trochanter (Table 3).
Primarna analiza podatkov iz študije BM 16550 po enem letu in potrditvena analiza po dveh letih sta pokazali, da v povprečnem zvišanju MKG ledvene hrbtenice, kolka, stegneničnega vratu in trohantra 3- mg injekcija, dana vsake 3 mesece ni manj učinkovita kot 2, 5 mg peroralno na dan (preglednica 3).
21 Table 3:
22 Preglednica 3.
One year data in study BM 16550
Povprečna relativna sprememba od izhodiščne vrednosti MKG ledvene hrbtenice, kolka, stegneničnega vratu in trohantra po enem letu (primarna analiza) in dveh letih zdravljenja (populacija po protokolu) v študiji BM 16550.
Two year data in study BM 16550
Dveletni podatki iz študije Enoletni podatki iz študije BM BM 16550 16550 Povprečna relativna
Mean relative changes
ibandronska
Bondenza ibandro
kislina 2, 5 mg
ibandronic acid Bondenza ibandronic
3 mg v obliki
Bondenza
v obliki
from baseline% [95% CI]
vrednosti% [95 -% interval
2.5 mg daily (N=377)
enkrat na dan
3 mg injection every 3 months (N=365)
injekcije vsake 3 mesece
acid 2.5 mg daily (N=334)
enkrat na dan (n = 334)
3 mg injection every 3 months (N=334)
injekcije vsake 3 mesece
Lumbar spine L2-L4 BMD
MKG ledvene hrbtenice L2– L4
Furthermore, Bondenza 3 mg injection every 3 months was proven superior to oral ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p < 0.001, and at two years, p < 0.001.
Zdravilo Bondenza 3 mg v obliki injekcije, dane vsake 3 mesece, se je izkazalo za boljše kakor peroralno dana ibandronska kislina 2, 5 mg enkrat na dan v povišanju MKG ledvene hrbtenice v prospektivno načrtovani analizi po enem letu, p < 0, 001, in dveh letih, p < 0, 001.
For lumbar spine BMD, 92.1% of patients receiving 3 mg injection every 3 months increased or maintained their BMD after 1 year of treatment (i. e. were responders) compared with 84.9% of patients receiving oral 2.5 mg daily (p=0.002).
MKG ledvene hrbtenice se je po enem letu povišala ali ostala enaka izhodiščni vrednosti pri 92, 1% bolnikov (t. i. odzivni bolniki), ki so prejemali 3- mg injekcijo vsake 3 mesece, in 84, 9% bolnikov, ki so prejemali 2, 5 mg na dan peroralno (p = 0, 002).
After 2 years of treatment, 92.8% of patients receiving 3 mg injections and 84.7% of patient receiving 2.5 mg oral therapy had increased or maintained lumbar spine BMD (p=0.001).
Po dveh letih zdravljenja se je MKG ledvene hrbtenice povišala ali ostala enaka izhodiščni vrednosti pri 92, 8% bolnikov, ki so prejemali 3- mg injekcije, in 84, 7% bolnikov, ki so prejemali peroralno zdravljenje z 2, 5 mg (p = 0, 001).
For total hip BMD, 82.3% of patients receiving 3 mg injection every 3 months were responders at one year, compared with 75.1% of patients receiving 2.5 mg daily orally (p=0.02).
Po enem letu je bilo na MKG kolka odzivnih 82, 3% bolnikov, ki so prejemali 3- mg injekcijo vsake 3 mesece, in 75, 1% bolnikov, ki so jemali 2, 5 mg na dan peroralno (p = 0, 02).
After 2 years of treatment, 85.6% of patients receiving 3 mg injections and 77.0% of patient receiving 2.5 mg oral therapy had increased or maintained total hip BMD (p=0.004).
Po dveh letih se je MKG kolka povišala ali ostala enaka izhodiščni vrednosti pri 85, 6% bolnikov, ki so prejemali 3- mg injekcije, in 77, 0% bolnikov, ki so prejemali peroralno zdravljenje z 2, 5 mg (p = 0, 004).
The proportion of patients who increased or maintained their BMD at one year at both lumbar spine and total hip was 76.2% in the 3 mg injection every 3 months arm and 67.2% in the 2.5 mg daily orally arm (p=0.007).
Delež bolnikov, ki se jim je MKG lumbalne hrbtenice in kolka povišala ali ostala enaka izhodiščni vrednosti po enem letu je bil 76, 2% v skupini, ki je prejemala 3- mg injekcijo vsake 3 mesece, in 67, 2% v skupini, ki je prejemala 2, 5 mg na dan peroralno (p = 0, 007).
At two years, 80.1% and 68.8% of patients met this criterion in the 3 mg every 3 months injection arm and the 2.5 mg daily arm (p=0.001).
Po dveh letih je tem kriterijem zadostilo 80, 1% bolnikov v skupini, ki je prejemala 3 mg vsake 3 mesece, in 68, 8% bolnikov v skupini, ki je prejemala 2, 5 mg na dan (p = 0, 001).
At 12 months median relative changes from baseline were – 58.6% for the intravenous injection of 3 mg every 3 months regimen and – 62.6% for oral 2.5 mg daily regimen.
Po 12 mesecih je bila mediana relativne spremembe od izhodiščne vrednosti – 58, 6% za odmerjanje 3 mg v obliki intravenskih injekcij vsake 3 mesece in – 62, 6% za peroralno odmerjanje 2, 5 mg na dan.
In addition, 64.8% of patients receiving 3 mg every 3 months injection were identified as responders (defined as a decrease ≥ 50% from baseline), compared with 64.9% of patients receiving 2.5 mg daily orally.
Poleg tega je bilo 64, 8% bolnikov, ki so prejemali 3- mg injekcijo vsake 3 mesece, odzivnih (odzivnost so definirali kot ≥ 50 -% zmanjšanje od izhodišča) v primerjavi s 64, 9% bolnikov, ki so prejemali 2, 5 mg na dan peroralno.
Based on the results of study BM 16550, Bondenza 3 mg intravenous injection, administered every 3 months is expected to be at least as effective in preventing fractures as the oral regimen of ibandronic acid 2.5 mg daily.
Glede na rezultate študije BM 16550 pričakujemo, da je Bondenza 3 mg v obliki intravenske injekcije, ki jo dajemo vsake 3 mesece, najmanj enako učinkovita v preprečevanju zlomov kakor peroralno odmerjena ibandronska kislina 2, 5 mg enkrat na dan.
22 Ibandronic acid 2.5 mg daily tablets
23 Ibandronska kislina, 2, 5- mg tableta, enkrat na dan
The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at the lumbar spine of -2 to -5 SD below the premenopausal mean (T-score) in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
Študija je vključevala ženske, stare od 55 do 80 let, ki so bile vsaj 5 let po menopavzi in ki so imele MKG ledvene hrbtenice – 2 do – 5 SD pod povprečno vrednostjo pred menopavzo (T- vrednost) pri vsaj enem vretencu (L1– L4) ter so imele enega do štiri predhodnih zlomov vretenc.
Efficacy was evaluated in 2,928 patients.
Učinkovitost so proučevali pri 2928 bolnicah.
Ibandronic acid 2.5 mg administered daily, showed a statistically significant and medically relevant reduction in the incidence of new vertebral fractures.
Dajanje 2, 5 mg ibandronske kisline na dan je povzročilo statistično značilno in klinično pomembno zmanjšanje incidence novih zlomov vretenc.
The incidence of clinical vertebral fractures was also significantly reduced by 49% after 3 years (p=0.011).
Incidenca kliničnih zlomov vretenc je bila značilno zmanjšana za 49% (p = 0, 011) po 3 letih.
The strong effect on vertebral fractures was furthermore reflected by a statistically significant reduction of height loss compared to placebo (p < 0.0001).
Močan vpliv na zlome vretenc se je kazal tudi z značilno manjšo izgubo telesne višine v primerjavi s placebom (p < 0, 0001).
Table 4:
Preglednica 4.
Relative risk reduction New morphometric vertebral fractures
ibandronska kislina 2, 5 mg
Placebo (N=974)
(n = 974)
ibandronic acid 2.5 mg daily (N=977) 62% (40.9, 75.1)
enkrat na dan (n = 977)
9.56% (7.5, 11.7)
62% (40, 9; 75, 1)
4.68%
9, 56
Relative risk reduction of clinical
Zmanjšanje relativnega tveganja za klinične zlome vretenc
vertebral fracture
Incidenca kliničnih zlomov vretenc
(14.03, 69.49)
5, 33%
Incidence of clinical vertebral fracture
2, 75%
5.33% (3.73, 6.92)
(3, 73; 6, 92)
2.75% (1.61, 3.89)
(1, 61; 3, 89)
1.26% (0.8, 1.7)
% (0, 8; 1, 7)
6.54% (6.1, 7.0)
% (6, 1; 7, 0)
BMD – mean change relative to baseline total hip at year 3
MKG – povprečna sprememba glede
-0.69% (-1.0, -0.4)
3, 36%
3.36% (3.0, 3.7)
(3, 0; 3, 7)
The treatment effect of ibandronic acid was further assessed in an analysis of the subpopulation of patients who, at baseline, had a lumbar spine BMD T-score below – 2.5 (table 5).
Učinek zdravljenja z ibandronsko kislino so nadalje proučevali v analizi podskupine bolnikov, katerih T- vrednost MKG ledvene hrbtenice je bila na začetku zdravljenja pod – 2, 5 (preglednica 5).
Results from 3 years fracture study MF 4411 (%, 95% CI) for patients with lumbar spine BMD T-score below – 2.5 at baseline
ki so imeli na začetku zdravljenja T- vrednost MKG ledvene hrbtenice pod – 2, 5.
Placebo (N=587)
placebo
Incidence of new morphometric vertebral fractures
ibandronska kislina 2, 5 mg
12.54%
(n = 587)
5.36% (3.31, 7.41)
enkrat na dan (n = 575)
Relative risk reduction of clinical vertebral fracture
Zmanjšanje relativnega tveganja za nove zlome vretenc (določeno morfometrično)
23
Incidenca novih zlomov vretenc (določeno morfometrično)
(N=575)
5, 36% (3, 31; 7, 41)
BMD – mean change relative to baseline lumbar spine at year 3
Incidenca kliničnih zlomov vretenc MKG – povprečna sprememba glede na izhodiščno vrednost za ledveno hrbtenico po 3 letih
3.59% (3.1, 4.1)
3, 59% (3, 1; 4; 1)
Daily oral treatment with ibandronic acid 2.5 mg tablets resulted in progressive increases in BMD at vertebral and nonvertebral sites of the skeleton.
Peroralno zdravljenje z 2, 5- mg tabletami ibandronske kisline enkrat na dan je povzročilo progresivno povišanje MKG vretenc in nevretenčnih delov skeleta.
Three-year lumbar spine BMD increase compared to placebo was 5.3% and 6.5% compared to baseline.
Porast MKG ledvene hrbtenice je po 3 letih v primerjavi s placebom znašal 5, 3%, v primerjavi z izhodiščno vrednostjo pa 6, 5%.
Biochemical markers of bone turnover (such as urinary CTX and serum Osteocalcin) showed the expected pattern of suppression to premenopausal levels and reached maximum suppression within a period of 3 - 6 months of using 2.5 mg ibandronic acid daily.
Biokemični označevalci kostne premene (kot so urinarni CTX in serumski osteokalcin) so pokazali pričakovan vzorec supresije do vrednosti pred menopavzo, največjo supresijo pa so dosegli po 3 do 6 mesecih uporabe 2, 5 mg ibandronske kisline enkrat na dan.
A clinically meaningful reduction of 50% of biochemical markers of bone resorption was observed as early as one month after starting treatment with ibandronic acid 2.5 mg.
Klinično pomembno 50 -% zmanjšanje biokemičnih označevalcev kostne resorpcije so opazili že en mesec po začetku zdravljenja z 2, 5 mg ibandronske kisline.
Plasma concentrations of ibandronic acid increase in a dose-proportional manner after intravenous administration of 0.5 mg to 6 mg.
Plazemske koncentracije ibandronske kisline se po intravenskem dajanju 0, 5 mg do 6 mg povečujejo sorazmerno z odmerkom.
Absorption Not applicable
Absorpcija Navedba smiselno ni potrebna.
Distribution After initial systemic exposure, ibandronic acid rapidly binds to bone or is excreted into urine.
Porazdelitev Po prvotni sistemski izpostavljenosti se ibandronska kislina hitro veže v kostno tkivo ali pa se izloči skozi ledvice.