Evidence map›Paper›PMID 23150144›Full record

Trial reportCalcified tissue international2013

A novel monthly dosing regimen of risedronate for the treatment of postmenopausal osteoporosis: 2-year data.

Michael R McClung, Claude-Laurent Benhamou, Zulema Man, Witold Tlustochowicz, Jose R Zanchetta, Rachelle Eusebio, Ana M Balske, Ellen Matzkin, Wojciech P Olszynski, Robert Recker and 1 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Calcified tissue international, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

5 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Bone safety with risedronate: histomorphometric studies at different dose levels and exposure.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
  3. The 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 · 2022
    Article
  4. Article
  5. Article
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

11 authors.

Michael R McClungOregon Osteoporosis Center, 5050 NE Hoyt Street, Suite 626, Portland, OR 97213, USA. mmcclung@orost.com
Claude-Laurent Benhamou
Zulema Man
Witold Tlustochowicz
Jose R Zanchetta
Rachelle Eusebio
Ana M Balske
Ellen Matzkin
Wojciech P Olszynski
Robert Recker
Pierre D Delmas

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This 2-year trial evaluated the efficacy and tolerability of a monthly oral regimen of risedronate. Postmenopausal women with osteoporosis were randomly assigned to double-blind treatment with risedronate 75 mg on 2 consecutive days each month (2CDM) or 5 mg daily. The primary end point was the percentage change from baseline in lumbar spine bone mineral density (BMD) at 12 months. Secondary end points included the change in BMD of the lumbar spine and proximal femur and in bone turnover markers as well as the number of subjects with at least one new vertebral fracture over 24 months. Among 1,229 patients who were randomized and received at least one dose of risedronate, lumbar spine BMD was increased in both treatment groups: mean percentage change from baseline was 4.2 ± 0.19 and 4.3 ± 0.19 % in the 75 mg 2CDM and 5 mg daily groups, respectively, at month 24. The treatment difference was 0.17 (95 % confidence interval -0.35 to 0.68). There were no statistically significant differences between treatment groups on any secondary efficacy parameters. Both treatment regimens were well tolerated. Risedronate 75 mg 2CDM was noninferior in BMD efficacy and did not show a difference in tolerability compared to 5 mg daily after 24 months of treatment in women with postmenopausal osteoporosis. This monthly regimen may provide a more convenient dosing schedule to some patients with postmenopausal osteoporosis.

Indexed as

AgedBone and BonesBone DensityBone Density Conservation AgentsDouble-Blind MethodDrug Administration ScheduleEtidronic AcidFemaleHumansLumbar VertebraeMiddle AgedOsteoporosis, PostmenopausalPatient SafetyResearch DesignRisedronic AcidSpinal FracturesBone Density Conservation AgentsEtidronic AcidRisedronic Acid

Identifiers

PMID23150144
PMCPMC3528955

What OpenQuestion holds

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LicenceCC BY
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.