-
Je něco špatně v tomto záznamu ?
Real-world Management of Women with Postmenopausal Osteoporosis Treated with Denosumab: A Prospective Observational Study in the Czech Republic and Slovakia
O. Růžičková, Z. Killinger, P. Kasalický, L. Hamilton, R. Tyl, S. Tomková, L. Kalouche-Khalil,
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, pozorovací studie, práce podpořená grantem
Odkazy
PubMed
30191465
DOI
10.1007/s12325-018-0779-9
Knihovny.cz E-zdroje
- MeSH
- denosumab * aplikace a dávkování škodlivé účinky MeSH
- hodnocení rizik MeSH
- hodnocení výsledků zdravotní péče MeSH
- inhibitory kostní resorpce aplikace a dávkování škodlivé účinky MeSH
- kostní denzita účinky léků MeSH
- lidé středního věku MeSH
- lidé MeSH
- osteoporotické fraktury * epidemiologie etiologie prevence a kontrola MeSH
- postmenopauzální osteoporóza * komplikace farmakoterapie epidemiologie MeSH
- prospektivní studie MeSH
- senioři MeSH
- služby preventivní péče metody statistika a číselné údaje MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- pozorovací studie MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Česká republika MeSH
- Slovenská republika MeSH
INTRODUCTION: Osteoporosis is characterized by low bone mineral density (BMD) and an increased risk of fracture. In randomized controlled trials, denosumab has been shown to significantly reduce the fracture risk in women with osteoporosis. However, little is known about the real-world management of women who are prescribed denosumab. METHODS: This multicenter, prospective, observational real-world study in the Czech Republic and Slovakia evaluated the baseline characteristics and clinical management of women with postmenopausal osteoporosis prescribed denosumab for 24 months. RESULTS: A total of 600 women were included (300 in each country). In the Czech Republic and Slovakia, respectively, mean age at enrollment was 69.0 and 64.3 years, 67.7% and 30.0% of patients had a previous osteoporotic fracture, and 85.0% and 48.7% had previously received osteoporosis medication. In both countries, 'low BMD T score' and 'a history of osteoporotic fracture' were the main reasons for prescribing denosumab. Most patients received all four post-baseline denosumab injections (Czech Republic, 82.0%; Slovakia, 81.0%), and more than 98% of patients in both countries received all injections at the prescribing center. At 24 months, most patients experienced an increase in BMD T score for the lumbar spine, total hip, or femoral neck (Czech Republic, 69.7-91.7%; Slovakia, 67.1-92.9%). Adverse drug reactions were consistent with the known safety profile of denosumab. CONCLUSION: Baseline characteristics of patients receiving denosumab in the Czech Republic and Slovakia reflect the reimbursement criteria for this agent in each country. The findings of our study in patients who are at high risk for fracture are consistent with the growing body of evidence demonstrating the effectiveness of denosumab in real-world clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01652690. FUNDING: Amgen Inc.
Bone Metabolism Unit Affidea Prague Czech Republic
Department of Internal Medicine P J Šafárik University Košice Hospital Košice Šaca Šaca Slovakia
Private Rheumatology and Osteology Department Osteomed Trutnov Czech Republic
- 000
- 00000naa a2200000 a 4500
- 001
- bmc19045255
- 003
- CZ-PrNML
- 005
- 20200526102036.0
- 007
- ta
- 008
- 200109s2018 xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1007/s12325-018-0779-9 $2 doi
- 035 __
- $a (PubMed)30191465
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Růžičková, Olga $u Institute of Rheumatology, Prague, Czech Republic. ruzickova@revma.cz. Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic. ruzickova@revma.cz.
- 245 10
- $a Real-world Management of Women with Postmenopausal Osteoporosis Treated with Denosumab: A Prospective Observational Study in the Czech Republic and Slovakia / $c O. Růžičková, Z. Killinger, P. Kasalický, L. Hamilton, R. Tyl, S. Tomková, L. Kalouche-Khalil,
- 520 9_
- $a INTRODUCTION: Osteoporosis is characterized by low bone mineral density (BMD) and an increased risk of fracture. In randomized controlled trials, denosumab has been shown to significantly reduce the fracture risk in women with osteoporosis. However, little is known about the real-world management of women who are prescribed denosumab. METHODS: This multicenter, prospective, observational real-world study in the Czech Republic and Slovakia evaluated the baseline characteristics and clinical management of women with postmenopausal osteoporosis prescribed denosumab for 24 months. RESULTS: A total of 600 women were included (300 in each country). In the Czech Republic and Slovakia, respectively, mean age at enrollment was 69.0 and 64.3 years, 67.7% and 30.0% of patients had a previous osteoporotic fracture, and 85.0% and 48.7% had previously received osteoporosis medication. In both countries, 'low BMD T score' and 'a history of osteoporotic fracture' were the main reasons for prescribing denosumab. Most patients received all four post-baseline denosumab injections (Czech Republic, 82.0%; Slovakia, 81.0%), and more than 98% of patients in both countries received all injections at the prescribing center. At 24 months, most patients experienced an increase in BMD T score for the lumbar spine, total hip, or femoral neck (Czech Republic, 69.7-91.7%; Slovakia, 67.1-92.9%). Adverse drug reactions were consistent with the known safety profile of denosumab. CONCLUSION: Baseline characteristics of patients receiving denosumab in the Czech Republic and Slovakia reflect the reimbursement criteria for this agent in each country. The findings of our study in patients who are at high risk for fracture are consistent with the growing body of evidence demonstrating the effectiveness of denosumab in real-world clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01652690. FUNDING: Amgen Inc.
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a kostní denzita $x účinky léků $7 D015519
- 650 _2
- $a inhibitory kostní resorpce $x aplikace a dávkování $x škodlivé účinky $7 D050071
- 650 12
- $a denosumab $x aplikace a dávkování $x škodlivé účinky $7 D000069448
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a lidé středního věku $7 D008875
- 650 12
- $a postmenopauzální osteoporóza $x komplikace $x farmakoterapie $x epidemiologie $7 D015663
- 650 12
- $a osteoporotické fraktury $x epidemiologie $x etiologie $x prevence a kontrola $7 D058866
- 650 _2
- $a hodnocení výsledků zdravotní péče $7 D017063
- 650 _2
- $a služby preventivní péče $x metody $x statistika a číselné údaje $7 D011314
- 650 _2
- $a prospektivní studie $7 D011446
- 650 _2
- $a hodnocení rizik $7 D018570
- 651 _2
- $a Česká republika $x epidemiologie $7 D018153
- 651 _2
- $a Slovenská republika $x epidemiologie $7 D018154
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a pozorovací studie $7 D064888
- 655 _2
- $a práce podpořená grantem $7 D013485
- 700 1_
- $a Killinger, Zdenko $u 5th Department of Internal Medicine, Faculty of Medicine, Comenius University and University Hospital, Bratislava, Slovakia.
- 700 1_
- $a Kasalický, Petr $u Bone Metabolism Unit, Affidea, Prague, Czech Republic.
- 700 1_
- $a Hamilton, Lisa $u Amgen Ltd, Uxbridge, UK.
- 700 1_
- $a Tyl, Roman $u Private Rheumatology & Osteology Department Osteomed, Trutnov, Czech Republic.
- 700 1_
- $a Tomková, Soňa $u Department of Internal Medicine, P.J. Šafárik University Košice, Hospital Košice-Šaca, Šaca, Slovakia.
- 700 1_
- $a Kalouche-Khalil, Lama $u Amgen (Europe) GmbH, Zug, Switzerland.
- 773 0_
- $w MED00179771 $t Advances in therapy $x 1865-8652 $g Roč. 35, č. 10 (2018), s. 1713-1728
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/30191465 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y a $z 0
- 990 __
- $a 20200109 $b ABA008
- 991 __
- $a 20200526102032 $b ABA008
- 999 __
- $a ok $b bmc $g 1483524 $s 1083928
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2018 $b 35 $c 10 $d 1713-1728 $e 20180906 $i 1865-8652 $m Advances in therapy $n Adv Ther $x MED00179771
- LZP __
- $a Pubmed-20200109