Evidence map›Paper›PMID 25236877›Full record

Observational studyOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2015

Persistence at 12 months with denosumab in postmenopausal women with osteoporosis: interim results from a prospective observational study.

S L Silverman, E Siris, D L Kendler, D Belazi, J P Brown, D T Gold, E M Lewiecki, A Papaioannou, C Simonelli, I Ferreira and 6 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02732210 (Prospective Observational Study to Evaluate Persistence With Prolia®), which is not on this map. Cited by 39 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing 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.

NCT02732210 completednot on this map

Prospective Observational Study to Evaluate Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis in Routine Clinical Practice

TypeobservationalSponsorAmgenRan2011 to 2014Enrolled935ConditionsOsteoporosis, Age-Related
3 · Its place in the literature

Who cites it

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

  1. 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
  2. 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
  3. Persistence with denosumab and persistence with oral bisphosphonates for the treatment of postmenopausal osteoporosis: a retrospective, observational study, and a meta-analysis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2015
    Pooled it
  4. Trial
  5. Article
  6. Article
  7. Article
  8. The efficacy of denosumab in Korean male patients with osteoporosis.The Korean journal of internal medicine · 2022
    Article
  9. Article
  10. Article
  11. The Widowhood Effect on Mortality in Older Patients with Hip Fracture.International journal of general medicine · 2022
    Article
  12. Article
  13. Article
  14. 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
  15. Article
  16. Cost-effectiveness of buffered soluble alendronate 70 mg effervescent tablet for the treatment of postmenopausal women with osteoporosis in Italy.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
  17. Article
  18. Article
  19. Adherence to fracture liaison service programs in patients over 70: the hidden part of the iceberg.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2020
    Article
  20. Persistence and compliance with osteoporosis therapies among postmenopausal women in the UK Clinical Practice Research Datalink.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2020
    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

16 authors.

S L SilvermanCedars-Sinai Medical Center and OMC Clinical Research Center, 8641 Wilshire Blvd, Suite 301, Los Angeles, CA, 90211, USA, stuarts@omcresearch.org.
E Siris
D L Kendler
D Belazi
J P Brown
D T Gold
E M Lewiecki
A Papaioannou
C Simonelli
I Ferreira
A Balasubramanian
P Dakin
P Ho
S Siddhanti
B Stolshek
C Recknor

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledTo determine persistence with subcutaneous denosumab every 6 months in women being treated for osteoporosis, we conducted a single-arm prospective, observational study in the United States and Canada. Among 935 patients enrolled, 12-month persistence was 82%, with 66 patients (7%) reporting serious adverse events and 19 patients (2%) reporting fractures.

introductionIncreased persistence with osteoporosis therapy is associated with reduced fracture risk. Denosumab reduced fracture risk in clinical trials; persistence in community settings is undetermined. This study evaluates persistence with denosumab in community practice in the United States (US) and Canada.

methodsIn a 24-month multicenter, prospective, single-arm, observational study, women being treated for osteoporosis were enrolled ≤4 weeks after the first subcutaneous injection of denosumab. For this 12-month prespecified interim analysis, endpoints include persistence (one injection at study entry and another within 6 months + 8 weeks), attributes associated with persistence (univariate analysis), and serious adverse events (SAEs).

resultsAmong 935 patients (mean age 71 years), mean baseline T-scores were -2.18 (femoral neck) and -2.00 (lumbar spine); 50% of patients had experienced osteoporotic fracture(s). At 12 months, 82 % of patients were persistent with denosumab. Baseline factors significantly (p < 0.05) associated with higher persistence included use of osteoporosis medications >5 years previously, lumbar spine T-score > -2.5, and treatment by female physicians (US). Lower persistence was associated (p < 0.05) with psychiatric diagnoses including depression, southern US residence, being divorced, separated, or widowed (US), and prior hip fracture (Canada). SAEs were reported in 66 patients (7%); no SAEs of osteonecrosis of the jaw, atypical femoral fracture, fracture healing complications, hypocalcemia, eczema, or hypersensitivity were reported. Nineteen patients (2%) reported osteoporotic fractures.

conclusionsThe 12-month persistence observed in this single-arm open-label study of US and Canadian community practice extends the evidence regarding denosumab's potential role in reducing fracture risk in postmenopausal women with osteoporosis.

Indexed as

Drug MonitoringAgedAged, 80 and overAntibodies, Monoclonal, HumanizedBone DensityBone Density Conservation AgentsCanadaDenosumabDrug Administration ScheduleFemaleFemur NeckHumansInjections, SubcutaneousLumbar VertebraeMiddle AgedOsteoporosis, PostmenopausalAntibodies, Monoclonal, HumanizedBone Density Conservation AgentsDenosumab

Identifiers

PMID25236877
PMCPMC4286624

What OpenQuestion holds

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LicenceCC BY-NC
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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.