Evidence map›Paper›PMID 16339289›Full record

Trial reportAnnals of the rheumatic diseases2006

Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study.

J-Y Reginster, S Adami, P Lakatos, M Greenwald, J J Stepan, S L Silverman, C Christiansen, L Rowell, N Mairon, B Bonvoisin and 6 more

Erratum issuedOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 90 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 21 pooled it
22.6field-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

90 citing papers in PubMed, 21 syntheses or guidelines pooled it, 329 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Guideline
  4. Pooled it
  5. Pooled it
  6. Guideline
  7. Pooled it
  8. 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 · 2019
    Guideline
  9. Pooled it
  10. Efficacy of bisphosphonates against osteoporosis in adult men: a meta-analysis of randomized controlled trials.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
  11. Pooled it
  12. Clinician's Guide to Prevention and Treatment of Osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2014
    Guideline
  13. Long-term fracture rates seen with continued ibandronate treatment: pooled analysis of DIVA and MOBILE long-term extension studies.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2014
    Pooled it
  14. 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
  15. Pooled it
  16. Evidence-based guidelines for the pharmacological treatment of postmenopausal osteoporosis: a consensus document by the Belgian Bone Club.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2010
    Guideline
  17. Pooled it
  18. Guideline
  19. Guideline
  20. 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 · 2008
    Guideline

30 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

16 authors at 14 institutions in 10 countries.

J-Y ReginsterUniversity of Liège, Liège, Belgium. jyreginster@ulg.ac.be
S Adami
P Lakatos
M Greenwald
J J Stepan
S L Silverman
C Christiansen
L Rowell
N Mairon
B Bonvoisin
M K Drezner
R Emkey
D Felsenberg
C Cooper
P D Delmas
P D Miller
Roche (Switzerland) · CHCedars-Sinai Medical Center · USCenter for Clinical & Basic Research · DKCharles University · CZDesert Medical Imaging · USHumboldt-Universität zu Berlin · DEPanorama Research (United States) · USRadiant Research (United States) · USSemmelweis University · HUUniversité Claude Bernard Lyon 1 · FRUniversity of Liège · BEUniversity of Southampton · GBUniversity of Verona · ITUniversity of Wisconsin–Madison · US

Funding

Medical Research Council G0400491Medical Research Council MC_UP_A620_1014
6 · The paper itself

Abstract

backgroundReducing bisphosphonate dosing frequency may improve suboptimal adherence to treatment and therefore therapeutic outcomes in postmenopausal osteoporosis. Once-monthly oral ibandronate has been developed to overcome this problem.

objectiveTo confirm the 1 year results and provide more extensive safety and tolerability information for once-monthly dosing by a 2 year analysis.

methodsMOBILE, a randomised, phase III, non-inferiority study, compared the efficacy and safety of once-monthly ibandronate with daily ibandronate, which has previously been shown to reduce vertebral fracture risk in comparison with placebo.

results1609 postmenopausal women were randomised. Substantial increases in lumbar spine bone mineral density (BMD) were seen in all treatment arms: 5.0%, 5.3%, 5.6%, and 6.6% in the daily and once-monthly groups (50 + 50 mg, 100 mg, and 150 mg), respectively. It was confirmed that all once-monthly regimens were at least as effective as daily treatment, and in addition, 150 mg was found to be better (p<0.001). Substantial increases in proximal femur (total hip, femoral neck, trochanter) BMD were seen; 150 mg produced the most pronounced effect (p<0.05 versus daily treatment). Independent of the regimen, most participants (70.5-93.5%) achieved increases above baseline in lumbar spine or total hip BMD, or both. Pronounced decreases in the biochemical marker of bone resorption, sCTX, observed in all arms after 3 months, were maintained throughout. The 150 mg regimen consistently produced greater increases in BMD and sCTX suppression than the 100 mg and daily regimens. Ibandronate was well tolerated, with a similar incidence of adverse events across groups.

conclusionsOnce-monthly oral ibandronate is at least as effective and well tolerated as daily treatment. Once-monthly administration may be more convenient for patients and improve therapeutic adherence, thereby optimising outcomes.

Indexed as

Administration, OralAgedAged, 80 and overBone DensityBone Density Conservation AgentsDiphosphonatesDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFemurHip JointHumansIbandronic AcidLumbar VertebraeMiddle AgedBone Density Conservation AgentsDiphosphonatesIbandronic Acid

Identifiers

PMID16339289
PMCPMC1798147
OpenAlexW2109465803

What OpenQuestion holds

Textmetadata
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.