Evidence map›Paper›PMID 28643265›Full record

Trial reportArchives of osteoporosis2017

Factors associated with high 24-month persistence with denosumab: results of a real-world, non-interventional study of women with postmenopausal osteoporosis in Germany, Austria, Greece, and Belgium.

A Fahrleitner-Pammer, N Papaioannou, E Gielen, M Feudjo Tepie, C Toffis, I Frieling, P Geusens, P Makras, E Boschitsch, J Callens and 5 more

Registry-linked trialAbstract readMulticenter StudyPragmatic Clinical Trial
In one paragraph

Trial report in Archives of osteoporosis, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01668589 (Prospective Observational Study to Evaluate Medication-taking Behavior With Denosumab), which is not on this map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
–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.

NCT01668589 completednot on this map

Prospective Observational Study to Evaluate Medication-taking Behavior With Denosumab (Prolia) and Patient Characteristics in Postmenopausal Women With Osteoporosis in Routine Clinical Practice in Germany, Austria, Greece and Belgium

TypeobservationalSponsorAmgenRan2011 to 2015Enrolled1,501ConditionsPostmenopausal Osteoporosis
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Persistence and adherence to parenteral osteoporosis therapies: a systematic review.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2020
    Pooled it
  3. A systematic review of factors affecting medication adherence among patients with osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2018
    Pooled it
  4. Denosumab-efficacy, safety, persistence and sequential strategies-a systematic review.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
    Review
  5. Article
  6. Article
  7. A quasi-experimental study about shared decision-making and motivational interviewing on patients with a recent fracture attending Fracture Liaison Services.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2024
    Article
  8. Article
  9. Article
  10. Article
  11. [Osteoporosis: diagnostics and treatment].Orthopadie (Heidelberg, Germany) · 2023
    Article
  12. Review
  13. [Osteoporosis: diagnostics and treatment].Zeitschrift fur Gerontologie und Geriatrie · 2022
    Article
  14. [Osteoporosis: diagnostics and treatment].Chirurgie (Heidelberg, Germany) · 2022
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Does theFrontiers in endocrinology · 2022
    Article
  20. Treatment patterns and long-term persistence with osteoporosis therapies in women with Medicare fee-for-service (FFS) coverage.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
    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

15 authors.

A Fahrleitner-PammerDepartment of Endocrinology and Metabolism, Medical University Graz, Graz, Austria.
N PapaioannouMedical School, Laboratory for the Research of Musculoskeletal System, KAT Hospital, University of Athens, Athens, Greece.
E GielenDepartment of Geriatrics and Center for Metabolic Bone Diseases, UZ Leuven, Leuven, Belgium.
M Feudjo TepieAmgen Ltd, Uxbridge, UK.
C ToffisAmgen Ltd, Cambridge, UK.
I FrielingOsteoporosis Center, Hamburg, Germany.
P GeusensDepartment of Internal Medicine, Maastricht University Medical Centre, Maastricht, Netherlands.
P MakrasDepartment of Endocrinology and Diabetes, 251 Hellenic Airforce and VA General Hospital, Athens, Greece.
E BoschitschAmbulatorium KLIMAX, Menopause and Osteoporosis Clinic, Vienna, Austria.
J CallensDepartment of Orthopedics, Rheumatology and Physical Medicine and Rehabilitation, AZ Zeno, Knokke, Belgium.
A D AnastasilakisDepartment of Endocrinology, 424 General Military Hospital, Thessaloniki, Greece.
C NiedhartOsteoporosis Center, Heinsberg, Germany.
H ReschMedical Department II, St Vincent Hospital, Academic Teaching Hospital of the Medical University of Vienna, Vienna, Austria.
L Kalouche-KhalilAmgen (Europe) GmbH, Zug, Switzerland.
P HadjiDepartment of Obstetrics and Gynecology, Krankenhaus Nordwest, Frankfurt, Germany. hadji.peyman@khnw.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Persistence with osteoporosis therapy is vital for fracture prevention. This non-interventional study of postmenopausal women receiving denosumab in Germany, Austria, Greece, and Belgium found that persistence with denosumab remains consistently high after 24 months in patients at high risk of fracture. PURPOSE: Continued persistence with osteoporosis therapy is vital for fracture prevention. This non-interventional study of clinical practice evaluated medication-taking behavior of postmenopausal women receiving denosumab in Germany, Austria, Greece, and Belgium and factors influencing persistence.

methodsSubcutaneous denosumab (60 mg every 6 months) was assigned according to prescribing information and local guidelines before and independently of enrollment; outcomes were recorded during routine practice for up to 24 months. Persistence was defined as receiving the subsequent injection within 6 months + 8 weeks of the previous injection and adherence as administration of subsequent injections within 6 months ± 4 weeks of the previous injection. Medication coverage ratio (MCR) was calculated as the proportion of time a patient was covered by denosumab. Associations between pre-specified baseline covariates and 24-month persistence were assessed using multivariable logistic regression.

resultsThe 24-month analyses included 1479 women (mean age 66.3-72.5 years) from 140 sites; persistence with denosumab was 75.1-86.0%, adherence 62.9-70.1%, and mean MCR 87.4-92.4%. No covariate had a significant effect on persistence across all four countries. For three countries, a recent fall decreased persistence; patients were generally older with chronic medical conditions. In some countries, other covariates (e.g., older age, comorbidity, immobility, and prescribing reasons) decreased persistence. Adverse drug reactions were reported in 2.3-6.9% patients.

conclusionsTwenty-four-month persistence with denosumab is consistently high among postmenopausal women in Europe and may be influenced by patient characteristics. Further studies are needed to identify determinants of low persistence.

Indexed as

Drug MonitoringAgedAge FactorsBone Density Conservation AgentsComorbidityDenosumabDrug Administration ScheduleEuropeFemaleHumansInjections, SubcutaneousMiddle AgedOsteoporosis, PostmenopausalOsteoporotic FracturesProspective StudiesRisk FactorsBone Density Conservation AgentsDenosumabAdherenceComplianceDenosumabNon-interventional studyOsteoporosisPersistence

Identifiers

PMID28643265
PMCPMC5486684

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.