Evidence map›Paper›PMID 19082528›Full record

Trial reportJournal of bone and mineral metabolism2009

Randomized controlled study on the prevention of osteoporotic fractures (OF study): a phase IV clinical study of 15-mg menatetrenone capsules.

Tetsuo Inoue, Toshiharu Fujita, Hideaki Kishimoto, Toshitaka Makino, Tetsuro Nakamura, Toshitaka Nakamura, Tosiya Sato, Kaoru Yamazaki

Registry-linked trialAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of bone and mineral metabolism, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04539418 (Effect of Vitamin K2 Supplementation on Vascular Calcification in Hemodialysis Patients), which is not on this map. Cited by 39 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 6 pooled it
2.2field-weighted citation impact, top 12% 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.

NCT04539418 phase4completednot on this mapstarted 2016, after this paper: background citation

Effect of Vitamin K2 Supplementation on Vascular Calcification in Hemodialysis Patients: a Controlled Randomized Trial.

TypeinterventionalSponsorCatholic University of SaltaRan2016 to 2017Enrolled59ConditionsRenal DiseaseArmsVitamin K 2
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 6 syntheses or guidelines pooled it, 89 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Effect of vitamin K on bone mineral density and fractures in adults: an updated systematic review and meta-analysis of randomised 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 · 2019
    Pooled it
  4. The efficacy and safety of menatetrenone in the management of osteoporosis: a systematic review and 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 · 2019
    Pooled it
  5. Does vitamin K2 play a role in the prevention and treatment of osteoporosis for postmenopausal women: 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
  6. Pooled it
  7. Comparison of concurrent treatment with vitamin KJournal of bone and mineral metabolism · 2017
    Trial
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  10. Vitamin K2 supplementation does not influence bone loss in early menopausal women: a randomised double-blind placebo-controlled trial.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2010
    Trial
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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

8 authors at 7 institutions in 2 countries.

Tetsuo InoueAoyama General Hospital, Kosakai, Japan.
Toshiharu Fujita
Hideaki Kishimoto
Toshitaka Makino
Tetsuro Nakamura
Toshitaka Nakamura
Tosiya Sato
Kaoru Yamazaki
Hamamatsu University · JPInstitute of Aging · CAJapan Chemical Industry Association · JPKyoto University · JPSanin Rosai Hospital · JPThe Institute of Statistical Mathematics · JPUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

An open-label study with blinded evaluation was performed to compare the preventive effect of a calcium supplement alone (monotherapy) or calcium supplement plus menatetrenone (combined therapy) on fracture in osteoporotic postmenopausal women aged 50 years or older. Patients were randomized to receive monotherapy (n = 2,193) or combined therapy (n = 2,185). Before randomization, the subjects were stratified into a subgroup without vertebral fractures (n = 2,986; no-fracture subgroup) and a subgroup with at least one vertebral fracture (n = 1,392; fracture subgroup). The incidence rate of new vertebral fractures during 36 months of treatment (primary endpoint) did not differ significantly between either subgroup of the two treatment groups. Although the cumulative 48-month incidence rate of new clinical fractures (secondary endpoint) was lower in the combined therapy group, the difference was not significant. There was a lower risk of new vertebral fractures in patients with at least five baseline fractures who received combined therapy. Also, the loss of height was less with combined therapy than with monotherapy among patients 75 years of age or older at enrollment, those whose last menstrual period occurred 30 years or more before enrollment, and those with at least five vertebral fractures at enrollment. Adverse events and adverse reactions were more frequent in the combined therapy group. In conclusion, menatetrenone therapy was not effective for preventing vertebral fractures in the full analysis set of this study, but the results suggested that it may prevent vertebral fractures in patients with more advanced osteoporosis.

Indexed as

Spinal FracturesAgedAged, 80 and overCalcium, DietaryDietary SupplementsDrug Therapy, CombinationFemaleHemostaticsHumansMiddle AgedOsteoporosis, PostmenopausalVitamin K 2Calcium, DietaryHemostaticsmenatetrenoneVitamin K 2

Identifiers

PMID19082528
OpenAlexW2137005590

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.