Evidence map›Paper›PMID 12972476›Full record

Trial reportAnnals of the rheumatic diseases2003

Intravenous ibandronate injections given every three months: a new treatment option to prevent bone loss in postmenopausal women.

J A Stakkestad, L I Benevolenskaya, J J Stepan, A Skag, A Nordby, E Oefjord, A Burdeska, I Jonkanski, P Mahoney, Ibandronate Intravenous Study Group

Open access · bronzeAbstract readClinical TrialClinical Trial, Phase IIClinical Trial, Phase III
In one paragraph

Trial report in Annals of the rheumatic diseases, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
8.8field-weighted citation impact, top 2% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 72 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Effective doses of ibandronate do not influence the 3-year progression of aortic calcification in elderly osteoporotic women.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2005
    Trial
  4. Article
  5. Article
  6. Validation of the Surrogate Threshold Effect for Change in Bone Mineral Density as a Surrogate Endpoint for Fracture Outcomes: The FNIH-ASBMR SABRE Project.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2022
    Article
  7. Article
  8. Intravenous bisphosphonates for postmenopausal osteoporosis.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2010
    Article
  9. Review
  10. Review
  11. Review
  12. Use of intravenous bisphosphonates in osteoporosis.Current osteoporosis reports · 2007
    Article
  13. Review
  14. Review
  15. Article
  16. Review
  17. Effective and rapid treatment of painful localized transient osteoporosis (bone marrow edema) with intravenous ibandronate.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2005
    Article
  18. Postmenopausal osteoporosis.Current osteoporosis reports · 2004
    Review
  19. Ibandronate in osteoporosis: preclinical data and rationale for intermittent dosing.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2004
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 5 countries.

J A StakkestadCECOR AS, Haugesund, Norway. jacobas@cecor.no
L I Benevolenskaya
J J Stepan
A Skag
A Nordby
E Oefjord
A Burdeska
I Jonkanski
P Mahoney
Ibandronate Intravenous Study Group
Roche (Switzerland) · CHLos Angeles Clinical Trials · USCharles University · CZNORCE Norwegian Research Centre · NONorwegian Veterinary Institute · NOVA Nasonova Scientific Research Institute of Rheumatology · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the efficacy, safety, and dose response of three doses of ibandronate, given intermittently by intravenous (IV) injection every three months, in preventing postmenopausal osteoporosis. PATIENTS AND

methods629 postmenopausal women, categorised according to time since menopause and baseline lumbar spine (L1-4) bone mineral density (BMD), were enrolled into a multicentre, double blind, placebo controlled trial. They were randomly allocated to receive IV ibandronate 0.5 mg, 1 mg or 2 mg, or placebo every three months. All women received daily calcium supplementation.

resultsOne year's treatment with intermittent IV ibandronate injections produced a dose dependent gain in mean (SD) lumbar spine BMD from baseline of 2.5 (2.5)%, 1.8 (2.6)%, and 1.0 (2.8)% in the groups receiving 2 mg, 1 mg, and 0.5 mg ibandronate, respectively, compared with a loss of BMD of 0.4 (2.4)% in the women in the placebo group; p=0.0001 for each ibandronate dose v placebo. Highest BMD gains occurred in women with osteopenia receiving 2 mg ibandronate. Similarly, at the hip, all three doses of ibandronate produced significantly better gains in BMD than placebo (p<0.05), with the greatest gains in the women with osteopenia receiving the 2 mg dose. Ibandronate concomitantly and dose dependently suppressed markers of bone turnover in comparison with placebo, and injections were well tolerated.

conclusionIV ibandronate injections, given every three months, may be an effective alternative to oral bisphosphonates and hormonal therapy in the prevention of bone loss in postmenopausal women.

Indexed as

Alkaline PhosphataseBiomarkersBone DensityCollagenCollagen Type ICzech RepublicDiphosphonatesDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHumansIbandronic AcidInjections, IntravenousLumbar VertebraeMiddle AgedAlkaline PhosphataseBiomarkersCollagenCollagen Type Icollagen type I trimeric cross-linked peptideDiphosphonatesIbandronic AcidOsteocalcinParathyroid HormonePeptides

Identifiers

PMID12972476
PMCPMC1754320
OpenAlexW2104515255

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.