natgillin/translations-raw huggingface dataset:
Clinical efficacy in the treatment of post-menopausal osteoporosis (PFT) The efficacy and safety of Aclasta 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).
Klinična učinkovitost pri zdravljenju postmenopavzalne osteoporoze (PFT) Učinkovitost in varnost zdravila Aclasta 5 mg na leto 3 leta zapored so dokazali pri postmenopavzalnih ženskah (7. 736 ženskah, starih 65- 89 let), ki so imele: bodisi vrednost T mineralne gostote kosti vratu stegnenice ≤ – 1, 5, pri tem pa prisotna vsaj dva manjša zloma ali en srednje hud zlom vretenca, ali pa vrednost T mineralne gostote kosti vratu stegnenice ≤ – 2, 5 z znaki prisotnega enega ali več zlomov vretenc ali brez njih.
85% of patients were bisphosphonate-naïve.
85% bolnic prej še ni prejemalo difosfonatov.
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.
7 so jih pregledovali glede zlomov vretenc, niso sočasno prejemale zdravil za zdravljenje osteoporoze, ki so jih sicer lahko prejemale tiste ženske, ki so jih pregledovali samo glede zlomov kolka in kliničnih zlomov.
All women received 1,000 to 1,500 mg elemental calcium and 400 to 1,200 IU of vitamin D supplements daily.
Vse ženske so prejemale dodatke 1. 000 do 1. 500 mg elementarnega kalcija in vitamina D v odmerkih 400 do 1. 200 i. e. dnevno.
Effect on morphometric vertebral fractures Aclasta significantly decreased the incidence of one or more new vertebral fractures over three years and as early as the one year timepoint (see Table 2).
Učinek na morfometrično opredeljene zlome vretenc Zdravilo Aclasta je statistično značilno znižalo incidenco enega ali več novih zlomov vretenc tako v obdobju treh let kot tudi že po enem letu opazovanja (glejte preglednico 2).
7 Table 2
Preglednica 2
Summary of vertebral fracture efficacy at 12, 24 and 36 months
Pregled učinkovitosti glede zlomov vretenc po 12, 24 in 36 mesecih
Aclasta Placebo Absolute reduction in (%) (%) fracture incidence% (CI)
Aclasta placebo absolutno znižanje (%) (%) odstotka zlomov% (IZ)
reduction in incidence% (CI)
relativno znižanje odstotka zlomov% (IZ)
At least one new vertebral fracture (0– 1 year)
vsaj en nov zlom vretenca (v prvem letu)
At least one new vertebral fracture (0– 2 year)
vsaj en nov zlom vretenca (v prvih dveh letih)
At least one new vertebral fracture (0– 3 year) ** p < 0.0001
vsaj en nov zlom vretenca (v prvih treh letih) ** p < 0, 0001
Aclasta-treated patients aged 75 years and older exhibited a 60% reduction in the risk of vertebral fractures compared to placebo patients (p < 0.0001).
Pri bolnikih, ki so bili stari 75 let ali starejši in so prejemali zdravilo Aclasta, je bilo tveganje za zlome vretenc za 60% manjše v primerjavi z bolniki, ki so prejemali placebo (p < 0, 0001).
Effect on hip fractures Aclasta demonstrated a consistent effect over 3 years, resulting in a 41% reduction in the risk of hip fractures (95% CI, 17% to 58%).
Učinek na zlome kolkov Zdravilo Aclasta je pokazalo stalen učinek v obdobju 3 let, kar je omogočilo 41- odstotno znižanje tveganja za zlom kolkov (95% IZ:
The hip fracture event rate was 1.44% for Aclasta-treated patients compared to 2.49% for placebo-treated patients.
Delež zlomov kolka je bil 1, 44% v skupini z zdravilom Aclasta v primerjavi z 2, 49% v skupini s placebom.
The risk reduction was 51% in bisphosphonate-naïve patients and 42% in patients allowed to take concomitant osteoporosis therapy.
Zmanjšanje tveganja je bilo 51- odstotno v skupini bolnikov, ki še niso jemali difosfonatov, in 42- odstotno pri bolnikih, ki so lahko sočasno jemali druga zdravila za zdravljenje osteoporoze.
Effect on all clinical fractures All clinical fractures were verified based on the radiographic and/ or clinical evidence.
Učinek na vse klinične zlome Vsi klinični zlomi so bili dokazani radiografsko in/ ali na podlagi kliničnih znakov.
Table 3
Pregled izsledkov je prikazan v preglednici 3.
Between treatment comparisons of the incidence over 3 years
Preglednica 3
of key clinical fracture variables
Primerjava incidenc ključnih kliničnih zlomov med obema načinoma zdravljenja v obdobju 3 let
Aclasta (N=3,875)
Aclasta placebo absolutno znižanje (N=3. 861) deleža zlomov% (N=3. 875)
Placebo Absolute reduction (N=3,861) in fracture event
relativno znižanje tveganja za zlome
Relative risk reduction in
delež (IZ) delež dogodkov dogodkov (%) (%)
event rate (%)
% (IZ)
event rate (%)
zlom (1) 8, 4 12, 8 4, 4 (3, 0, 5, 8)
rate% (CI)
33 (23, 42) **
fracture incidence% (CI)
klinični zlom vretenca (2)
Any clinical fracture (1) Clinical vertebral fracture (2) Non-vertebral fracture (1) *p-value < 0.001, **p-value < 0.0001
2, 6
8.4 0.5 8.0
2, 1 (1, 5, 2, 7)
12.8 2.6 10.7
77 (63, 86) **
4.4 2.1 2.7
10, 7
(3.0, 5.8) (1.5, 2.7) (1.4, 4.0)
2, 7 (1, 4, 4, 0)
33 (23, 42)** 77 (63, 86)** 25 (13, 36)*
25 (13, 36) *
(1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures
* vrednost p < 0, 001, ** vrednost p < 0, 0001 (1) brez zlomov prstov rok in nog ter zlomov na področju obraza (2) vključno s kliničnimi zlomi prsnih in ledvenih vretenc
Effect on bone mineral density (BMD) Aclasta significantly increased BMD at the lumbar spine, hip, and distal radius relative to treatment with placebo at all timepoints (6, 12, 24 and 36 months).
8 Učinek na mineralno gostoto kosti (bone mineral density - BMD) Zdravilo Aclasta je statistično značilno povečalo mineralno gostoto kosti ledvene hrbtenice, kolka in distalnega dela koželjnice v primerjavi s placebom po vseh obdobjih opazovanja (po 6, 12, 24 in 36 mesecih).
Treatment with Aclasta resulted in a 6.7% increase in BMD at the lumbar spine, 6.0% at the total hip, 5.1% at the femoral neck, and 3.2% at the distal radius over 3 years as compared to placebo.
Zdravljenje z zdravilom Aclasta je v obdobju 3 let zvečalo mineralno gostoto kosti ledvene hrbtenice za 6, 7%, celotnega kolka za 6, 0%, vratu stegnenice za 5, 1% in distalnega dela koželjnice za 3, 2% v primerjavi s placebom.
Bone histology Bone biopsies were obtained from the iliac crest 1 year after the third annual dose in 152 post- menopausal patients with osteoporosis treated with Aclasta (N=82) or placebo (N=70).
Histologija kosti Eno leto po tretjem letnem odmerku so 152 postmenopavzalnim bolnicam z osteoporozo, ki so se zdravile z zdravilom Aclasta (N=82) oziroma s placebom (N=70) opravili biopsijo kosti iz grebena črevnice (crista iliaca).
Histomorphometric analysis showed a 63% reduction in bone turnover.
Histomorfometrična analiza je pokazala 63% zmanjšanje kostne presnove.
Microcomputed
Označevanje s tetraciklini je bilo mogoče odkriti v vseh 82 biopsijskih vzorcih bolnic, ki so bile zdravljene z zdravilom Aclasta z izjemo enega vzorca.
8 tomography (μ CT) analysis demonstrated increased trabecular bone volume and preservation of trabecular bone architecture in patients treated with Aclasta compared to placebo.
Analiza s pomočjo mikroračunalniške tomografije (μCT) je pokazala povečan volumen trabekularne kostnine in ohranjeno trabekularno strukturo kosti pri bolnicah, ki so se zdravile z zdravilom Aclasta, v primerjavi s tistimi, ki so prejemale placebo.
Bone turnover markers Bone specific alkaline phosphatase (BSAP), serum N-terminal propeptide of type I collagen (P1NP) and serum beta-C-telopeptides (b-CTx) were evaluated in subsets ranging from 517 to 1,246 patients at periodic intervals throughout the study.
Markerji kostne presnove V celotnem poteku študije so podskupinam, ki so zajemale od 517 do 1. 246 bolnic, v rednih intervalih pregledovali kostno specifično alkalno fosfatazo (bone specific alkaline phosphatase - BSAP), N- končni propeptid kolagena tipa I (N- terminal propeptide of type I collagen - P1NP) v serumu in beta C- telopeptide (b- CTx).
Treatment with a 5 mg annual dose of Aclasta significantly reduced BSAP by 30% relative to baseline at 12 months which was sustained at 28% below baseline levels at 36 months.
Zdravljenje z odmerkom zdravila Aclasta 5 mg na leto je statistično značilno znižalo vrednosti kostno specifične alkalne fosfataze po 12 mesecih za 30% glede na izhodišče.
P1NP was significantly reduced by 61% below baseline levels at 12 months and was sustained at 52% below baseline levels at 36 months.
Vrednosti N- končnega propeptida kolagena tipa I so se po 12 mesecih statistično značilno znižale za 61% od izhodiščnih vrednosti, znižanje se je po 36 mesecih ohranilo na vrednosti 52% pod izhodiščnimi vrednostmi.
B-CTx was significantly reduced by 61% below baseline levels at 12 months and was sustained at 55% below baseline levels at 36 months.
Vrednosti beta C- telopeptida so se po 12 mesecih statistično značilno znižale za 61% od izhodiščnih vrednosti, znižanje se je po 36 mesecih ohranilo na vrednosti 55% pod izhodiščnimi vrednostmi.
During this entire time period bone turnover markers were within the pre-menopausal range at the end of each year.
V celotnem obdobju so bile ob koncu vsakega leta vrednosti markerjev kostne presnove v okviru premenopavzalnih vrednosti.
Repeat dosing did not lead to further reduction of bone turnover markers.
Ponovljeno odmerjanje ni povzročalo nadaljnega zniževanja vrednosti markerjev kostne presnove.
Effect on height In the three-year osteoporosis study standing height was measured annually using a stadiometer.
Učinek na telesno višino V triletni študiji osteoporoze so enkrat na leto s stadiometrom izmerili telesno višino.
The Aclasta group revealed approximately 2.5 mm less height loss compared to placebo (95% CI:
V skupini z zdravilom Aclasta je bilo zniževanje telesne višine za približno 2, 5 mm manjše kot v skupini s placebom (95% IZ:
Days of disability Aclasta significantly reduced the mean days of limited activity and the days of bed rest due to back pain by 17.9 days and 11.3 days respectively compared to placebo and significantly reduced the mean days of limited activity and the days of bed rest due to fractures by 2.9 days and 0.5 days respectively compared to placebo (all p < 0.01).
Poleg tega je v primerjavi s placebom statistično značilno znižalo povprečno število dni z omejeno aktivnostjo zaradi zlomov za 2, 9 dni in število dni, v katerih je zaradi zlomov potreben počitek v postelji, za 0, 5 dni (v vseh primerih p < 0, 01).
Clinical efficacy in the treatment of osteoporosis in patients at increased risk of fracture after a recent hip fracture (RFT) The incidence of clinical fractures, including vertebral, non-vertebral and hip fractures, was evaluated in 2,127 men and women aged 50-95 years (mean age 74.5 years) with a recent (within 90 days) low- trauma hip fracture who were followed for an average of 2 years on study medication.
Klinična učinkovitost pri zdravljenju osteoporoze pri bolnikih s povečanim tveganjem za zlome po nedavnem zlomu kolka (RFT) Incidenco kliničnih zlomov, vključno z zlomi vretenc, nevretenčnimi zlomi in zlomi kolka, so vrednotili pri 2. 127 moških in ženskah, starih 50- 95 let (povprečna starost 74, 5 let) z nedavnim (v okviru 90 dni) zlomom kolka po lažji poškodbi, ki so jih opazovali povprečno 2 leti med zdravljenjem s študijskim zdravilom.
Approximately 42% of patients had a femoral neck BMD T-score below -2.5 and approximately 45% of the patients had a femoral neck BMD T-score above -2.5.
Približno 42% bolnikov je imelo vrednost T mineralne gostote kosti vratu stegnenice pod - 2, 5 in približno 45% bolnikov je imelo vrednost T mineralne gostote kosti vratu stegnenice nad - 2, 5.
Aclasta was administered once a year, until at least 211 patients in the study population had confirmed clinical fractures.
Zdravilo Aclasta so prejemali enkrat na leto, dokler ni vsaj pri 211 bolnikih v študiji prišlo do dokazanega kliničnega zloma.
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.
Koncentracij vitamina D niso merili rutinsko, vendar je večina bolnikov 2 tedna pred infuzijo prejela večji začetni odmerek vitamina D (50. 000 do
All participants received 1,000 to 1,500 mg of elemental calcium plus 800 to 1,200 IU of vitamin D supplementation per day.
Vsi preiskovanci so prejemali dodatke 1. 000 do 1. 500 mg elementarnega kalcija in 800 do 1. 200 i. e. vitamina D na dan.
Ninety-five percent of the patients received their infusion two or more weeks after the hip fracture repair and the median timing of infusion was approximately six weeks after the hip fracture repair.
Petindevetdeset odstotkov bolnikov je prejelo infuzijo dva ali več tednov po zacelitvi zloma kolka, pri tem je bil mediani čas odmerjanja infuzije približno šest tednov po zacelitvi zloma kolka.
9 Table 4
Preglednica 4
Between treatment comparisons of the incidence of key clinical fracture variables
Primerjava incidenc ključnih kliničnih zlomov med obema načinoma zdravljenja
Aclasta Placebo Absolute reduction (N=1,065) (N=1,062) in fracture event
Izid
event rate event rate (%) (%)
placebo absolutno znižanje (N=1. 065) (N=1. 062) deleža zlomov% delež delež (IZ) dogodkov dogodkov (%) (%)
rate% (CI)
relativno znižanje tveganja za zlome% (IZ)
Any clinical fracture (1) Clinical vertebral fracture (2) Non-vertebral fracture (1) *p-value < 0.05, **p-value < 0.01
katerikoli klinični zlom (1) klinični zlom vretenca (2) nevretenčni zlom (1) * vrednost p < 0, 05, ** vrednost p < 0, 01
35 (16, 50)** 46 (8, 68)* 27 (2, 45)*
35 (16, 50) ** 46 (8, 68) * 27 (2, 45) *
(1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures
(1) brez zlomov prstov rok in nog ter zlomov na področju obraza (2) vključno s kliničnimi zlomi prsnih in ledvenih vretenc
All cause mortality was 10% (101 patients) in the Aclasta-treated group compared to 13% (141 patients) in the placebo group.
Umrljivost iz vseh vzrokov je bila 10% v skupini, zdravljeni z zdravilom Aclasta (101 bolnik), v primerjavi s 13% v skupini s placebom (141 bolnikov).
This corresponds to a 28% reduction in the risk of all cause mortality (p=0.01).
To ustreza 28- odstotnemu zmanjšanju tveganja za umrljivost iz vseh vzrokov (p=0, 01).
The incidence of delayed hip fracture healing was comparable between Aclasta (34 [3.2%]) and placebo (29 [2.7%]).
Incidenca zakasnitve celjenja zloma kolka je bila primerljiva med skupinama z zdravilom Aclasta (34 [3, 2%]) oziroma s placebom (29 [2, 7%]).
Effect on bone mineral density (BMD) In the HORIZON-RFT study Aclasta treatment significantly increased BMD at the total hip and femoral neck relative to treatment with placebo at all timepoints.
Učinek na mineralno gostoto kosti (bone mineral density - BMD) V študiji HORIZON- RFT je zdravljenje z zdravilom Aclasta ob vseh časih opazovanja pomembno povečalo mineralno gostoto kosti celotnega kolka in vratu stegnenice v primerjavi s placebom.
Treatment with Aclasta resulted in an increase in BMD of 5.4% at the total hip and 4.3% at the femoral neck over 24 months as compared to placebo.
Zdravljenje z zdravilom Aclasta je po 24 mesecih v primerjavi s placebom povzročilo povečanje mineralne gostote kosti celotnega kolka za 5, 4% in vratu stegnenice za 4, 3%.
Clinical efficacy in men In the HORIZON-RFT study 508 men were randomised into the study and 185 patients had BMD assessed at 24 months.
Klinična učinkovitost pri moških V študijo HORIZON- RFT so naključno izbrali 508 moških in 185 bolnikom so po 24 mesecih ocenili mineralno gostoto kosti.
At 24 months a similar significant increase of 3.6% in total hip BMD was observed for patients treated with Aclasta as compared to the effects observed in post-menopausal women in the HORIZON-PFT study.
Po 24 mesecih so pri bolnikih, ki so prejemali zdravilo Aclasta, opažali pomembno 3, 6- odstotno povečanje mineralne gostote kosti celotnega kolka, kar je podobno učinkom, ki so jih opažali pri postmenopavzalnih ženskah v študiji HORIZON- PFT.
The study was not powered to show a reduction in clinical fractures in men; the incidence of clinical fractures was 7.5% in men treated with Aclasta versus 8.7% for placebo.
S študijo ni bilo mogoče pokazati zmanjšanja obsega kliničnih zlomov pri moških; incidenca kliničnih zlomov je bila pri moških, zdravljenih z zdravilom Aclasta, 7, 5% v primerjavi z 8, 7% pri uporabi placeba.
Clinical efficacy in the treatment of Paget’ s disease of the bone Aclasta was studied in male and female patients aged above 30 years with primarily mild to moderate Paget’ s disease of the bone (median serum alkaline phosphatase level 2.6– 3.0 times the upper limit of the age-specific normal reference range at the time of study entry) confirmed by radiographic evidence.
10 Klinična učinkovitost pri zdravljenju Pagetove bolezni kosti Zdravilo Aclasta so proučevali pri bolnicah in bolnikih, starejših od 30 let, z rentgenološko potrjeno primarno blago do zmerno Pagetovo boleznijo kosti (mediana aktivnost alkalne fosfataze v serumu je bila 2, 6 do 3- krat večja od zgornje meje starostno specifičnega normalnega referenčnega območja v času vstopa v študijo).
The efficacy of one infusion of 5 mg zoledronic acid versus daily doses of 30 mg risedronate for 2 months was demonstrated in two 6-month comparative trials.
Ena infuzija 5 mg zoledronske kisline se je izkazala za bolj učinkovito kot odmerek 30 mg rizedronata na dan v 2 mesecih v dveh 6– mesečnih primerjalnih preskusih.
After 6 months, Aclasta 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).
Po 6 mesecih je zdravilo Aclasta pokazalo 96- odstotno (169/ 176) oziroma 89- odstotno odzivnost (156/ 176) oziroma pogostost normalizacije vrednosti serumske alkalne fosfataze (SAP) v primerjavi s 74% (127/ 171) oziroma 58% (99/ 171) pri rizedronatu (v vseh primerih p < 0, 001).
In the pooled results, a similar decrease in pain severity and pain interference scores relative to baseline were observed over 6 months for Aclasta and risedronate.
V združenih rezultatih so po 6 mesecih za zdravilo Aclasta in rizedronat ugotovili podobno zmanjšanje rezultatov ugotavljanja intenzivnosti bolečine in njenega oviranja vsakdanjih aktivnosti glede na izhodišče.
10 Patients who were classified as responders at the end of the 6 month core study were eligible to enter an extended follow-up period.
Bolniki, ki so se odzvali na zdravljenje v 6- mesečni osnovni študiji, so veljali za primerne za podaljšano spremljanje.
Of the 143 Aclasta-treated patients and 107 risedronate-treated patients who entered an extended observation study, after a median duration of follow-up of 18 months from time of dosing, 141 Aclasta-treated patients maintained their therapeutic response compared to 71 risedronate-treated patients.
Od 143 bolnikov, zdravljenih z zdravilom Aclasta, in 107 bolnikov, zdravljenih z rizedronatom, ki so bili vključeni v študijo podaljšanega opazovanja, je po mediani trajanja spremljanja 18 mesecev od časa odmerjanja terapevtski odziv vzdrževalo 141 bolnikov, zdravljenih z zdravilom Aclasta, in 71 bolnikov, zdravljenih z rizedronatom.
This corresponds to a 96% reduction of risk of relapse in Aclasta versus risedronate-treated patients.
To ustreza 96- odstotnemu zmanjšanju tveganja za ponovitev bolezni pri bolnikih, zdravljenih z zdravilom Aclasta, v primerjavi s tistimi, ki so bili zdravljeni z rizedronatom.
Bone histology was evaluated in 7 patients with Paget’ s disease 6 months after treatment with 5 mg zoledronic acid.
Histologijo kosti so ovrednotili pri 7 bolnikih s Pagetovo boleznijo 6 mesecev po zdravljenju s 5 mg zoledronske kisline.
These results were consistent with biochemical marker evidence of normalisation of bone turnover.
Dobljeni rezultati so se skladali z dokazi biokemijskih markerjev normalizacije kostne presnove.
Single and multiple 5 and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients yielded the following pharmacokinetic data, which were found to be dose independent.
Enkratne in večkratne 5- minutne in 15- minutne infuzije po 2, 4, 8 in 16 mg zoledronske kisline so pri 64 bolnikih dale naslednje farmakokinetične podatke, za katere so ugotovili, da so neodvisni od odmerka.
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.
Po začetku infundiranja zoledronske kisline so se koncentracije zdravilne učinkovine v plazmi hitro zvišale, dosegle ob koncu infundiranja vrh, ki mu je sledilo hitro znižanje na < 10% najvišje dosežene vrednosti po 4 urah in na < 1% najvišje dosežene vrednosti po 24 urah, čemur je sledilo dolgotrajno obdobje zelo nizkih koncentracij, ki niso presegle 0, 1% najvišje vrednosti.
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.
Intravensko dana zoledronska kislina se odstranjuje iz telesa s trifaznim procesom: hitro dvofazno izginotje iz sistemskega krvnega obtoka z razpolovnima časoma t1/ 2α 0, 24 ure in t1/ 2β 1, 87 ure, ki mu sledi dolga faza izločanja s končnim razpolovnim časom izločanja t1/ 2χ 146 ur.
Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
V prvih 24 urah se v seč izloči 39 ± 16% danega odmerka, preostanek pa se predvsem veže v kostno tkivo.
The total body clearance is 5.04 ± 2.5 l/ h, independent of dose, and unaffected by gender, age, race or body weight.
Skupni telesni očistek je 5, 04 ± 2, 5 l/ h, je neodvisen od odmerka in nanj ne vplivajo spol, starost, rasa ali telesna masa.
The inter- and intra-subject variation for plasma clearance of zoledronic acid was shown to be 36% and 34%, respectively.
Pokazali so, da je variabilnost plazemskega očistka zoledronske kisline med preiskovanci 36%, pri posameznem preiskovancu pa 34%.
No specific drug-drug interaction studies have been conducted with zoledronic acid.
11 Z zoledronsko kislino niso opravili specifičnih študij medsebojnega delovanja z drugimi zdravili.
Since zoledronic acid is not metabolised in humans and the substance was found to have little or no capacity as a direct- acting and/ or irreversible metabolism-dependent inhibitor of P450 enzymes, zoledronic acid is unlikely to reduce the metabolic clearance of substances which are metabolised via the cytochrome P450 enzyme systems.
Ker človek ne presnavlja zoledronske kisline in ker so ugotovili, da ta zdravilna učinkovina v manjši meri ali pa sploh ne deluje kot neposredno delujoči in/ ali ireverzibilni, od presnove odvisni, zaviralec encimov P450, ni verjetno, da bi zoledronska kislina zmanjšala presnovni očistek snovi, ki se presnavljajo prek encimskega sistema citokrom P450.
Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and binding is concentration independent.
Zoledronska kislina se ne veže v veliki meri na beljakovine plazme (vezana je približno v 43- 55%), vezava pa je neodvisna od koncentracije.
Special populations (see section 4.2) The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/ min (range 22 to 143 ml/ min) in the 64 patients studied.
Ledvični očistek je znašal 75 ± 33% kretininskega očistka, ki je pri 64 proučevanih bolnikih pokazal srednjo vrednost 84 ± 29 ml/ min (obseg 22 do 143 ml/ min).