Evidence map›Paper›PMID 30191465›Full record

Observational studyAdvances in therapy2018

Real-world Management of Women with Postmenopausal Osteoporosis Treated with Denosumab: A Prospective Observational Study in the Czech Republic and Slovakia.

Olga Růžičková, Zdenko Killinger, Petr Kasalický, Lisa Hamilton, Roman Tyl, Soňa Tomková, Lama Kalouche-Khalil

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Advances in therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01652690 (Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia® in Routine Clinical Practice), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01652690 completednot on this map

Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia® in Routine Clinical Practice

TypeobservationalSponsorAmgenRan2012 to 2015Enrolled600ConditionsOsteoporosis, PostmenopausalArmsDenosumab
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Olga RůžičkováInstitute of Rheumatology, Prague, Czech Republic. ruzickova@revma.cz.ORCID 0000-0003-4284-1003
Zdenko Killinger5th Department of Internal Medicine, Faculty of Medicine, Comenius University and University Hospital, Bratislava, Slovakia.
Petr KasalickýBone Metabolism Unit, Affidea, Prague, Czech Republic.
Lisa HamiltonAmgen Ltd, Uxbridge, UK.
Roman TylPrivate Rheumatology & Osteology Department Osteomed, Trutnov, Czech Republic.
Soňa TomkováDepartment of Internal Medicine, P.J. Šafárik University Košice, Hospital Košice-Šaca, Šaca, Slovakia.
Lama Kalouche-KhalilAmgen (Europe) GmbH, Zug, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOsteoporosis 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.

methodsThis 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.

resultsA 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.

conclusionBaseline 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 registrationClinicalTrials.gov identifier, NCT01652690.

fundingAmgen Inc.

Indexed as

DenosumabOsteoporosis, PostmenopausalOsteoporotic FracturesAgedBone DensityBone Density Conservation AgentsCzech RepublicFemaleHumansMiddle AgedOutcome Assessment, Health CarePreventive Health ServicesProspective StudiesRisk AssessmentSlovakiaBone Density Conservation AgentsDenosumabClinical practiceCzech RepublicDenosumabOsteoporosisPostmenopausalSlovakia

Identifiers

PMID30191465
PMCPMC6182647

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.