Evidence map›Paper›PMID 15959614›Full record

ReviewOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2006

A new concept for bisphosphonate therapy: a rationale for the development of monthly oral dosing of ibandronate.

Jean-Yves Reginster, Dieter Felsenberg, Cyrus Cooper, Jacob A Stakkestad, Paul D Miller, David L Kendler, Silvano Adami, Michael R McClung, Michael A Bolognese, Roberto Civitelli and 4 more

Abstract readReview
PubMed Publisher
In one paragraph

Review in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
6.1field-weighted citation impact, top 4% 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

14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. A systematic review of persistence and compliance with bisphosphonates for osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2007
    Pooled it
  4. Article
  5. Dietary NaturalMolecules (Basel, Switzerland) · 2018
    Article
  6. Balicatib, a cathepsin K inhibitor, stimulates periosteal bone formation in monkeys.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2012
    Article
  7. Balicatib, a cathepsin K inhibitor, stimulates periosteal bone formation in monkeys.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2011
    Article
  8. Partial adherence: a new perspective on health economic assessment in osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2011
    Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
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

14 authors at 12 institutions in 9 countries.

Jean-Yves ReginsterUnite d'Exploration du Metabolisme de l'Os et du Cartilage, CHU Centre Ville, Liége, Belgium. jyreginster@ulg.ac.be
Dieter Felsenberg
Cyrus Cooper
Jacob A Stakkestad
Paul D Miller
David L Kendler
Silvano Adami
Michael R McClung
Michael A Bolognese
Roberto Civitelli
Etienne Dumont
Bernard Bonvoisin
Robert R Recker
Pierre D Delmas
Bone Health and Osteoporosis Foundation · USCentre Hospitalier Universitaire de Liège · BEColorado Center for Bone Research · USCreighton University · USFreie Universität Berlin · DEGlaxoSmithKline (United States) · USOsteoporosis Canada · CARoche (Switzerland) · CHSouthampton General Hospital · GBUniversité Claude Bernard Lyon 1 · FRUniversity of Verona · ITWashington University in St. Louis · US

Funding

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

Abstract

Oral daily and weekly bisphosphonates represent the current mainstay of treatment for postmenopausal osteoporosis (PMO). However, the inconvenience of frequent dosing is known to negatively affect adherence to therapy in the long term. This has prompted the development of convenient oral bisphosphonate regimens that feature simple, less frequent dosing schedules. Such regimens require high potency agents, which can be given at low effective doses and that also have good tolerability. Ibandronate is a potent, nitrogen-containing bisphosphonate with proven efficacy when given intermittently to estrogen-depleted beagle dogs, rats and cynomolgus monkeys. Clinically, a pivotal prospective study has established that oral ibandronate has significant vertebral fracture efficacy in PMO, whether given daily (2.5 mg) or intermittently (20 mg every other day for 12 doses every 3 months; extended between-dose interval>2 months). Both oral regimens were well tolerated, which is noteworthy as patients with a history of gastrointestinal (GI) disturbance were not specifically excluded. As a result of these findings, a large, multinational, randomized, double-blind study (Monthly Oral iBandronate In LadiEs: MOBILE) is currently exploring the non-inferiority of once-monthly oral ibandronate (100 or 150 mg) to the oral daily ibandronate (2.5 mg) regimen with proven anti-fracture efficacy, in terms of lumbar spine bone mineral density (BMD) change. As with the trials investigating the weekly administration of other bisphosphonates, vertebral fracture efficacy will be inferred if the study demonstrates the non-inferiority of once-monthly ibandronate to the proven oral daily regimen in terms of spinal BMD change. The availability of this once-monthly ibandronate regimen is expected to offer benefits in terms of convenience (by having to follow dosing recommendations once a month vs. once daily or weekly) and potentially tolerability (by reducing the potential for upper GI irritation that can result from frequent, repeated exposure). Greater convenience and tolerability may enhance the therapy adherence and, hence, improve long-term therapeutic outcomes in PMO.

Indexed as

Administration, OralAnimalsBone DensityBone Density Conservation AgentsClinical Trials, Phase I as TopicDiphosphonatesDogsDrug Administration ScheduleFemaleHumansIbandronic AcidLumbar VertebraeMiddle AgedOsteoporosis, PostmenopausalPatient ComplianceRandomized Controlled Trials as TopicBone Density Conservation AgentsDiphosphonatesIbandronic Acid

Identifiers

PMID15959614
OpenAlexW2007180210

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.