Evidence map›Paper›PMID 22124575›Full record

Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2012

Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis.

J-Y Reginster, J-M Kaufman, S Goemaere, J P Devogelaer, C L Benhamou, D Felsenberg, M Diaz-Curiel, M-L Brandi, J Badurski, J Wark and 3 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 3 pooled it
11.4field-weighted citation impact, top 1% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 3 syntheses or guidelines pooled it, 109 citations in OpenAlex.

  1. Pooled it
  2. Strontium ranelate as a possible disease-modifying osteoarthritis drug: a systematic review.Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2018
    Pooled it
  3. European guidance for the diagnosis and management of osteoporosis in postmenopausal women.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2013
    Guideline
  4. Trial
  5. Review
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  9. Effect of Height of Fall on Mortality in Patients with Fall Accidents: A Retrospective Cross-Sectional Study.International journal of environmental research and public health · 2020
    Article
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  12. Review
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  14. Effect of strontium ranelate on pain behavior in an experimental model of osteoarthritis.Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2017
    Article
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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

13 authors at 10 institutions in 8 countries.

J-Y ReginsterDepartment of Public Health and Health Economics, University of Liège, Liège, Belgium. jyreginster@ulg.ac.be
J-M Kaufman
S Goemaere
J P Devogelaer
C L Benhamou
D Felsenberg
M Diaz-Curiel
M-L Brandi
J Badurski
J Wark
A Balogh
O Bruyère
C Roux
Ghent University Hospital · BEUniversity of Liège · BEBone Health and Osteoporosis Foundation · USCentre hospitalier régional d'Orléans · FRHospital Universitario Fundación Jiménez Díaz · ESKlinik und Poliklinik für Nuklearmedizin · DEUCLouvain · BEUniversité Paris Cité · FRUniversity of Debrecen · HUUniversity of Melbourne · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledIn an open-label extension study, BMD increased continuously with strontium ranelate over 10 years in osteoporotic women (P < 0.01). Vertebral and nonvertebral fracture incidence was lower between 5 and 10 years than in a matched placebo group over 5 years (P < 0.05). Strontium ranelate's antifracture efficacy appears to be maintained long term.

introductionStrontium ranelate has proven efficacy against vertebral and nonvertebral fractures, including hip, over 5 years in postmenopausal osteoporosis. We explored long-term efficacy and safety of strontium ranelate over 10 years.

methodsPostmenopausal osteoporotic women participating in the double-blind, placebo-controlled phase 3 studies SOTI and TROPOS to 5 years were invited to enter a 5-year open-label extension, during which they received strontium ranelate 2 g/day (n = 237, 10-year population). Bone mineral density (BMD) and fracture incidence were recorded, and FRAX® scores were calculated. The effect of strontium ranelate on fracture incidence was evaluated by comparison with a FRAX®-matched placebo group identified in the TROPOS placebo arm.

resultsThe patients in the 10-year population had baseline characteristics comparable to those of the total SOTI/TROPOS population. Over 10 years, lumbar BMD increased continuously and significantly (P < 0.01 versus previous year) with 34.5 ± 20.2% relative change from baseline to 10 years. The incidence of vertebral and nonvertebral fracture with strontium ranelate in the 10-year population in years 6 to 10 was comparable to the incidence between years 0 and 5, but was significantly lower than the incidence observed in the FRAX®-matched placebo group over 5 years (P < 0.05); relative risk reductions for vertebral and nonvertebral fractures were 35% and 38%, respectively. Strontium ranelate was safe and well tolerated over 10 years.

conclusionsLong-term treatment with strontium ranelate is associated with sustained increases in BMD over 10 years, with a good safety profile. Our results also support the maintenance of antifracture efficacy over 10 years with strontium ranelate.

Indexed as

AgedAged, 80 and overBone DensityBone Density Conservation AgentsDouble-Blind MethodDrug Administration ScheduleFemaleFemur NeckFollow-Up StudiesHip JointHumansLumbar VertebraeOrganometallic CompoundsOsteoporosis, PostmenopausalOsteoporotic FracturesThiophenesBone Density Conservation AgentsOrganometallic Compoundsstrontium ranelateThiophenes

Identifiers

PMID22124575
PMCPMC3277702
OpenAlexW2012535104

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.