natgillin/translations-raw huggingface dataset:
Patienter i behandling med Zometa bør ikke behandles med Aclasta.
Aclasta contains the same active substance found in Zometa (zoledronic acid), used for oncology indications, and a patient being treated with Zometa should not be treated with Aclasta.
Osteonekrose af kæberne:
Osteonecrosis of the jaw (ONJ):
Osteonekrose af kæberne er blevet rapporteret overvejende hos patienter med cancer, som får et behandlingsregime, der også omfatter bisfosfonater, herunder zoledronsyre.
Osteonecrosis of the jaw has been reported predominantly in patients with cancer receiving treatment regimens including bisphosphonates, including zoledronic acid.
Størstedelen af de rapporterede tilfælde har været i forbindelse med tandoperationer, så som udtrækning af en tand.
The majority of reported cases have been associated with dental procedures such as tooth extraction.
Mange viste tegn på lokal infektion inklusive osteomyelitis.
Many had signs of local infection including osteomyelitis.
Et tandeftersyn med passende forebyggende tandbehandling bør overvejes før behandling med bisfosfonater hos patienter med flere samtidige risikofaktorer (f. eks. cancer, kemoterapi, kortikosteroider, dårlig mundhygiejne).
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e. g. cancer, chemotherapy, corticosteroids, poor oral hygiene).
Den behandlende læges kliniske bedømmelse bør bestemme behandlingsplanen for den enkelte patient baseret på vurdering af individuel fordel/ risiko.
The clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/ risk assessment.
Der er ikke udført specifikke lægemiddelinteraktionsstudier med zoledronsyre.
Specific drug-drug interaction studies have not been conducted with zoledronic acid.
5. 2).
Zoledronic acid is not systemically metabolised and does not affect human cytochrome P450 enzymes in vitro (see section 5.2).
Zoledronsyre bindes ikke mærkbart til plasmaproteiner (cirka 43- 55% bundet), og interaktioner med stærkt proteinbundende stoffer på grund af fortrængning, er derfor usandsynlig.
Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and interactions resulting from displacement of highly protein-bound drugs are therefore unlikely.
Forsigtighed tilrådes når Aclasta administreres samtidig med lægemidler, der har en signifikant indvirkning på nyrefunktionen (f. eks. aminoglykosider eller diuretika, som kan forårsage dehydrering).
Caution is indicated when Aclasta is administered in conjunction with medicinal products that can significantly impact renal function (e. g. aminoglycosides or diuretics that may cause dehydration).
5. 3).
Studies in animals with zoledronic acid have shown reproductive toxicological effects including malformations (see section 5.3).
Det vides ikke, om zoledronsyre udskilles i human brystmælk.
It is not known whether zoledronic acid is excreted into human breast milk.
4. 3).
Aclasta is contraindicated during pregnancy and in breast-feeding women (see section 4.3).
4. 8 Bivirkninger
4 4.8 Undesirable effects
Den overordnede procentdel af patienter, som oplevede symptomer efter dosering, var henholdsvis 44, 7%, 16, 7% og 10, 2% efter første, anden og tredje infusion.
The overall percentage of patients who experienced post-dose symptoms were 44.7%, 16.7% and 10.2% after the first, second and third infusion, respectively.
Feber (17, 1%), muskelsmerter (7, 8%), influenzalignende symptomer (6, 7%), ledsmerter (4, 8%) og hovedpine (5, 1%).
Incidence of individual symptoms following the first infusion was: fever (17.1%), myalgia (7.8%), flu-like symptoms (6.7%), arthralgia (4.8%) and headache (5.1%).
Incidensen af disse symptomer faldt markant ved de efterfølgende doser af Aclasta.
The incidence of these symptoms decreased markedly with subsequent doses of Aclasta.
Størstedelen af disse symptomer opstår inden for de første tre dage efter administration af Aclasta.
The majority of these symptoms occur within the first three days following Aclasta administration.
Størstedelen af disse symptomer var milde til moderate og ophørte
The majority of these symptoms were mild to moderate and resolved within three days of the event onset.
Procentdelen af patienter, som oplevede symptomer efter dosering, var lavere i et mindre studie (19, 5%, 10, 4%, 10, 7% efter henholdsvis den første, anden og tredje infusion), hvor profylakse mod post- doseringssymptomer blev anvendt som beskrevet nedenfor.
The percentage of patients who experienced post-dose symptoms was lower in a smaller study (19.5%, 10.4%, 10.7% after the first, second and third infusion, respectively), where prophylaxis against post-dose symptoms was used as described below.
4. 2).
The incidence of post-dose symptoms occurring within the first three days after administration of Aclasta can be reduced with the administration of paracetamol or ibuprofen shortly following Aclasta administration (see section 4.2).
I HORIZON – Betydningsfuld Fraktur Studie [PFT] (se pkt.
In the HORIZON – Pivotal Fracture Trial [PFT] (see section 5.1), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving Aclasta and placebo, respectively.
5. 1) var den generelle forekomst af atrieflimren 2, 5% (96 ud af 3. 852) og 1, 9% (75 ud af 3. 852) hos patienter, som fik henholdsvis Aclasta og placebo.
The rate of atrial fibrillation serious adverse events was increased in patients receiving Aclasta (1.3%) (51 out of 3,862) compared with patients receiving placebo (0.6%) (22 out of 3,852).
Frekvensen af atrieflimren som alvorlig utilsigtigt hændelse var øget hos patienter i behandling med Aclasta (1, 3%) (51 ud af 3. 862) sammenlignet med patienter som modtog placebo (0, 6%) (22 ud af 3. 852) Mekanismen bag den øgede forekomst af atrieflimren er ukendt.
The mechanism behind the increased incidence of atrial fibrillation is unknown.
I osteoporoseforsøget (PFT, HORIZON – Tilbagevendende Fraktur Studie [RFT] var den samlede incidens for atrieflimren sammenlignelig for Aclasta (2, 6%) og placebo (2, 1%).
In the osteoporosis trials (PFT, HORIZON - Recurrent Fracture Trial [RFT]) the pooled atrial fibrillation incidences were comparable between Aclasta (2.6%) and placebo (2.1%).
For alvorlige bivirkninger af atrieflimren var den samlede incidens 1, 3% for Aclasta og 0, 8% for placebo.
For atrial fibrillation serious adverse events the pooled incidences were 1.3% for Aclasta and 0.8% for placebo.
Meget almindelige ≥ 1/ 10), almindelige (≥ 1/ 100 til, < 1/ 10), ikke almindelige (≥ 1/ 1. 000 til, < 1/ 100), sjældne (≥1/ 10. 000 til, < 1/ 1. 000) er opført i tabel 1.
Very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1,000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1,000) adverse drug reactions are shown in Table 1.
Tabel 1 *
Table 1*
Undersøgelser Hjerte Nervesystemet
Investigations Cardiac disorders Nervous system disorders
Ikke almindelige Almindelig Almindelige Ikke almindelige
Uncommon Common Common Uncommon
Forhøjet blodtryk Atrieflimren Hovedpine, svimmelhed Lethargia, paræstesi, somnolens, tremor, synkope
Blood pressure increased Atrial fibrillation Headache, dizziness Lethargy, paraesthesia, somnolence, tremor, syncope
Øjne
Eye disorders
Konjunktivit, øjensmerter Uveit, episklerit, irit
Conjunctivitis, eye pain Uveitis, episcleritis, iritis
Øre og labyrint Luftveje, thorax og mediastinum Mave- tarmkanalen
Ear and labyrinth disorders Respiratory, thoracic and mediastinal disorders
Ikke almindelig Ikke almindelig Almindelige Ikke almindelige
Uncommon Uncommon
Vertigo Dyspnø Kvalme, opkastning Diarré, dyspepsi, mavesmerter, mundtørhed
Vertigo Dyspnoea
Nyrer og urinveje Hud og subkutane væv
Gastrointestinal disorders
Ikke almindelige Ikke almindelig
Common Uncommon
Blodkreatinin øget, pollakiuri Udslæt, nattesved, hyperhidrose, pruritus, erytem
Nausea, vomiting Diarrhoea, dyspepsia, abdominal pain, dry mouth
Knogler, led, muskler og bindevæv
Renal and urinary disorders Skin and subcutaneous tissue disorders
Almindelige
Uncommon Uncommon
Muskelsmerter, ledsmerter, knoglesmerter, rygsmerter, smerter i ekstremitet
Blood creatinine increased, pollakiuria Rash, night sweats, hyperhydrosis, pruritus, erythema
Nakkesmerter, stivhed i bevægeapparatet, hævelse af led, skuldersmerter, muskelkramper, smerter i bevægeapparatet, ikke- hjertebetingede brystsmerter, arthritis, muskelsvækkelse, ledstivhed
Myalgia, arthralgia, bone pain, back pain, pain in extremity Neck pain, musculoskeletal stiffness, joint swelling, shoulder pain, muscle spasms, musculoskeletal pain, non-cardiac chest pain, arthritis, muscular weakness, joint stiffness
Hypocalcæmia † Anoreksi, nedsat appetit
Hypocalcaemia† Anorexia, decreased appetite
Infektioner og parasitære sygdomme Vaskulære sygdomme
5
5 Almene symptomer og reaktionr på administrationsstedet
Infections and infestations Vascular disorders General disorders and administration site conditions
Meget almindelig Almindelige
Uncommon Uncommon Very common Common
Feber Influenzalignende symptomer, kulderystelser, træthed, asteni, smerter, utilpashed, rigor †
Influenza Hypertension, flushing Fever Flu-like symptoms, chills, fatigue, asthenia, pain, malaise, rigors†
Perifert ødem, tørst
Peripheral oedema, thirst
Ikke kendt **
Not known**
Hypersensitivitetsreaktioner inklusive sjældne tilfælde af bronkokonstriktion, urticaria og angioødem, og meget sjældne tilfælde af anafylaktisk reaktion/ shock
Hypersensitivity reactions including rare cases of bronchoconstriction, urticaria and angioedema, and very rare cases of anaphylactic reaction/ shock
* Yderligere bivirkninger, som blev rapporterede i de enkelte studier, men som ikke blev inkluderet i den samlede præsentation, er:
* Additional adverse events which were reported in the individual studies but were not included due to the pooled presentation are:
Ikke almindelig: smagsforstyrrelse, øsofagit, tandpine. † Kun almindelig ved Pagets sygdom.
Uncommon: dysgeusia, oesophagitis, toothache. † Common in Paget’ s disease only.
Se også tekst nedenfor vedrørende hypocalcæmia. ** Baseret på post- marketing rapporter.
For hypocalcaemia, see also text below. ** Based on post-marketing reports.
Det er ikke muligt at lave et pålideligt estimat over frekvensen eller at påvise en årsagssammenhæng, da disse rapporter stammer fra en befolkning af ukendt størrelse og indeholder modstridende oplysninger.
Since these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency or establish a causal relationship to exposure to the medicinal product.
Nedsat nyrefunktion Zoledronsyre er associeret med nedsat nyrefunktion manifesteret som en forringelse af nyrefunktionen (dvs. øget serumkreatinin) og i sjældne tilfælde akut nyresvigt.
Renal dysfunction Zoledronic acid has been associated with renal dysfunction manifested as deterioration in renal function (i. e. increased serum creatinine) and in rare cases acute renal failure.
Renal dysfunktion er set efter administration af zoledronsyre, specielt hos patienter med eksisterende nyreproblemer eller yderligere risikofaktorer (f. eks. onkologipatienter i kemoterapibehandling, samtidig behandling med nefrotoksisk medicin, svær dehydrering), hvoraf de fleste modtog en dose på 4 mg hver 3. - 4. uge, men det er set hos patienter efter en enkelt administration.
Renal dysfunction has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal compromise or additional risk factors (e. g oncology patients with chemotherapy, concomitant nephrotoxic medications, severe dehydration), the majority of whom received a 4 mg dose every 3– 4 weeks, but it has been observed in patients after a single administration.
I kliniske studier om osteoporose var ændringen i kreatininclearance (målt årligt før dosering) og incidensen af nyresvigt og nedsat nyrefunktion sammenlignelig for Aclasta - og placebobehandlingsgruppen over tre år.
In clinical trials in osteoporosis, the change in creatinine clearance (measured annually prior to dosing) and the incidence of renal failure and impairment was comparable for both the Aclasta and placebo treatment groups over three years.
Der sås en forbigående stigning i serumkreatinin inden for 10 dage hos 1, 8% af patienterne behandlet med Aclasta mod 0, 8% hos patienterne behandlet med placebo.
There was a transient increase in serum creatinine observed within 10 days in 1.8% of Aclasta-treated patients versus 0.8% of placebo-treated patients.
Hypocalcæmi I kliniske studier om osteoporose havde omkring 0, 2% af patienterne et betydeligt fald i serumcalciumniveauet (mindre end 1, 87 mmol/ l) efter administration af Aclasta.
Hypocalcaemia In clinical trials in osteoporosis, approximately 0.2% of patients had notable declines of serum calcium levels (less than 1.87 mmol/ l) following Aclasta administration.
Der sås ingen symptomatiske tilfælde af hypocalcæmi.
No symptomatic cases of hypocalcaemia were observed.
1% af patienterne, og det forsvandt hos alle.
In the Paget’ s disease trials, symptomatic hypocalcaemia was observed in approximately 1% of patients, in all of whom it resolved.
Laboratorieundersøgelser viste forbigående kalciumniveauer under den normale referenceværdi (mindre end 2, 10 mmol/ l) hos 2, 3% af de Aclasta- behandlede patienter i et større klinisk studie sammenlignet med 21% af Aclasta- behandlede patienter i de kliniske forsøg med Pagets sygdom.
Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less than 2.10 mmol/ l) occurred in 2.3% of Aclasta-treated patients in a large clinical trial compared to 21% of Aclasta-treated patients in the Paget’ s disease trials.
Frekvensen af hypocalcæmi var meget lavere efter de efterfølgende infusioner.
The frequency of hypocalcaemia was much lower following subsequent infusions.
4. 2).
All patients received adequate supplementation with vitamin D and calcium in the post-menopausal osteoporosis trial, the prevention of clinical fractures after hip fracture trial, and the Paget’ s disease trials (see also section 4.2).
4. 2).
In the trial for the prevention of clinical fractures following a recent hip fracture, vitamin D levels were not routinely measured but the majority of patients received a loading dose of vitamin D prior to Aclasta administration (see section 4.2).
Lokale reaktioner I et større klinisk studie blev der rapporteret lokale reaktioner som rødme, hævelse og/ eller smerter på infusionsstedet (0, 7%) efter administration af zoledronsyre.
Local reactions In a large clinical trial, local reactions at the infusion site, such as redness, swelling and/ or pain, were reported (0.7%) following the administration of zoledronic acid.
6 Osteonekrose af kæberne I sjældne tilfælde er osteonekrose (primært i kæberne) blevet rapporteret overvejende hos cancerpatienter, der er i behandling med bisfosfonater, herunder zoledronsyre.
6 Osteonecrosis of the jaw Uncommonly, cases of osteonecrosis (primarily of the jaw) have been reported, predominantly in cancer patients treated with bisphosphonates, including zoledronic acid.
Der er mange veldokumenterede risikofaktorer for osteonekrose i kæberne inklusive cancer- diagnose, samtidige behandlinger (f. eks. kemoterapi, strålebehandling, kortikosteroider) og følgesygdomme (f. eks. anæmi, koagulationslidelse, infektion, præ- eksisterende tandsygdomme).
Osteonecrosis of the jaw has multiple well documented risk factors including a diagnosis of cancer, concomitant therapies (e. g. chemotherapy, radiotherapy, corticosteroids) and co-morbid conditions (e. g. anaemia, coagulopathies, infection, pre- existing dental disease).
Selvom årsagen ikke er blevet bestemt, er det klogt at undgå tandoperationer, fordi helbredelsen kan blive forlænget (se pkt.
Although causality has not been determined, it is prudent to avoid dental surgery as recovery may be prolonged (see section 4.4).
I et større klinisk studie med 7. 736 patienter er der rapporteret om osteonekrose i kæberne hos en patient behandlet med Aclasta og en patient behandlet med placebo.
In a large clinical trial in 7,736 patients, osteonecrosis of the jaw has been reported in one patient treated with Aclasta and one patient treated with placebo.
Der er ingen erfaring med akut forgiftning med Aclasta.
There is no experience of acute intoxication with Aclasta.
I tilfælde af klinisk signifikant hypocalcæmi kan tilstanden reverseres ved supplerende oral calcium og/ eller intravenøs infusion af calciumglukonat.
In the event of overdose leading to clinically significant hypocalcaemia, reversal may be achieved with supplemental oral calcium and/ or an intravenous infusion of calcium gluconate.
Farmakoterapeutisk klassifikation:
Pharmacotherapeutic group:
Bisfosfonat, ATC- kode:
Bisphosphonate, ATC code:
Virkningsmekanisme Zoledronsyre tilhører gruppen af nitrogenholdige bisfosfonater og virker primært på knoglerne.
Mechanism of action Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone.
Laveste niveau blev nået for resorptionsmarkørene efter 7 dage og for formationsmarkørene efter 12 uger.
Pharmacodynamic effects Aclasta treatment rapidly reduced the rate of bone turnover from elevated post-menopausal levels with the nadir for resorption markers observed at 7 days, and for formation markers at 12 weeks.
Klinisk effekt ved behandling af postmenopausal osteoporose [PFT] Virkning og sikkerhed af Aclasta 5 mg en gang årligt i 3 konsekutive år er påvist hos post - menopausale kvinder (7. 736 kvinder i alderen 65- 89 år) med enten: en knoglemineraltæthed (BMD) med en t- score for lårbenshalsen ≤ - 1, 5, og mindst to milde eller en moderat eksisterende vertebral( e) fraktur( er); eller en BMD T- score for lårbenshalsen ≤ - 2, 5 med eller uden bevis for eksisterende vertebral (e) fraktur( er).
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).
85% af patienterne blev behandlet med bisphosphonat for første gang.
85% of patients were bisphosphonate-naïve.
Kvinder, som blev evalueret for incidens af vertebrale frakturer, modtog ikke samtidig osteporosebehandling, hvilket var tilladt for kvinder, som bidrog til evalueringerne af hoftefrakturer og alle kliniske frakturer.
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.
Alle kvinder modtog 1. 000 til 1. 500 mg usammensat calcium og 400 til 1. 200 IU D- vitamintilskud dagligt.
All women received 1,000 to 1,500 mg elemental calcium and 400 to 1,200 IU of vitamin D supplements daily.
Effekt på morfometriske vertebrale frakturer Aclasta reducerede incidensen af en eller flere nye vertebrale frakturer signifikant over 3 år og så tidligt som ved 1 år (se tabel 2).
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).
7 Tabel 2 Resumé af effekt på vertebrale frakturer ved 12, 24 og 36 måneder
Summary of vertebral fracture efficacy at 12, 24 and 36 months
Absolut reduktion af
Aclasta Placebo Absolute reduction in (%) (%) fracture incidence% (CI)
Relativ reduktion af
Relative fracture
frakturincidens% (CI)
reduction in incidence% (CI)
Mindst en ny vertebral fraktur (0- 1 år)
At least one new vertebral fracture (0– 1 year)
Mindst en ny vertebral fraktur (0- 2 år)
At least one new vertebral fracture (0– 2 year)
Mindst en ny vertebral fraktur (0- 3 år) ** p < 0, 0001
At least one new vertebral fracture (0– 3 year) ** p < 0.0001
Patienter på 75 år og derover, der blev behandlet med Aclasta, reducerede risikoen med 60% for vertebral fraktur sammenlignet med placebo patienter (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).
Effekt på hoftefrakturer Aclasta viste en konsistent effekt over 3 år på 41% reduktion i risikoen for hoftefrakturer (95% CI, 17% til 58%).
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%).
Hændelsesraten for hoftefrakturer var 1, 44% for patienter behandlet med Aclasta sammenlignet med 2, 49% for patienter behandlet med placebo.
The hip fracture event rate was 1.44% for Aclasta-treated patients compared to 2.49% for placebo-treated patients.
Risikoreduktionen var 51% for patienter som ikke havde fået bifosfonat tidligere og 42% for patienter, som fik lov at være i samtidig osteoporosebehandling.
The risk reduction was 51% in bisphosphonate-naïve patients and 42% in patients allowed to take concomitant osteoporosis therapy.
Effekt på alle kliniske frakturer Alle kliniske frakturer blev verificeret ud fra radiografi og/ eller klinisk dokumentation.
Effect on all clinical fractures All clinical fractures were verified based on the radiographic and/ or clinical evidence.
Sammenligninger mellem behandlinger af incidensen af vigtige kliniske frakturvariabler over 3 år
Between treatment comparisons of the incidence over 3 years
Aclasta Placebo Absolut reduktion i
of key clinical fracture variables
Relativ
Outcome
(N=3. 875)
Aclasta (N=3,875)
(N=3. 861)
Placebo Absolute reduction (N=3,861) in fracture event
frakturhændelses -
Relative risk reduction in
risikoreduktion i
event rate (%)
hændelses - hændelses - rate (%) rate (%)
event rate (%)
rate% (CI)
rate% (CI)
frakturincidens% (CI)
fracture incidence% (CI)
Alle kliniske frakturer (1) Klinisk vertebral fraktur (2) Ikke- vertebral fraktur (1) * p- værdi < 0, 001, ** p- værdi < 0, 0001
Any clinical fracture (1) Clinical vertebral fracture (2) Non-vertebral fracture (1) *p-value < 0.001, **p-value < 0.0001
8, 4 0, 5 8, 0
8.4 0.5 8.0
12, 8 2, 6 10, 7
12.8 2.6 10.7
4, 4 (3, 0, 5, 8) 2, 1 (1, 5, 2, 7) 2, 7 (1, 4, 4, 0)
(3.0, 5.8) (1.5, 2.7) (1.4, 4.0)
33 (23, 42) ** 77 (63, 86) ** 25 (13, 36) *
33 (23, 42)** 77 (63, 86)** 25 (13, 36)*
(1) Ekskl. frakturer på fingre, tær og ansigt (2) Inkl. kliniske frakturer på torakale og lumbale ryghvirvler
(1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures
Effekt på knoglemineraltæthed (BMD) Aclasta øgede BMD signifikant ved den lumbale columna, hofte og distale radius i forhold til behandling med placebo på alle tidspunkter (6, 12, 24 og 36 måneder).
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).
Behandling med Aclasta resulterede i en øgning af BMD med 6, 7% ved den lumbale columna, 6, 0% ved total hofte, 5, 1% ved lårbenshals og 3, 2% ved den distale radius over 3 år sammenlignet med placebo.
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.
Knoglehistologi Der blev udført biopsier fra crista iliaca 1 år efter den tredje årlige dose på 152 postmenopausale patienter med osteoporose behandlet med Aclasta (N=82) eller placebo (N=70).
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).
Den histomorfometriske analyse viste en 63% reduktion i knogleomsætningen.
Histomorphometric analysis showed a 63% reduction in bone turnover.
Tetracyklinmarkering kunne påvises i alle, undtagen en, af de 82 biopsier fra patienter på Aclasta.
Microcomputed