Evidence map›Paper›PMID 26466937›Full record

Trial reportCalcified tissue international2016

Efficacy and Safety of Risedronate in Osteoporosis Subjects with Comorbid Diabetes, Hypertension, and/or Dyslipidemia: A Post Hoc Analysis of Phase III Trials Conducted in Japan.

Daisuke Inoue, Ryoichi Muraoka, Ryo Okazaki, Yoshiki Nishizawa, Toshitsugu Sugimoto

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Calcified tissue international, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 14% 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

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Bone Health in Patients With Type 2 Diabetes.Journal of the Endocrine Society · 2024
    Article
  7. Review
  8. Review
  9. Biochemical Markers of Bone Fragility in Patients with DiabetesThe Journal of clinical endocrinology and metabolism · 2023
    Article
  10. Article
  11. Observational
  12. Review
  13. Review
  14. Article
  15. Article
  16. Diabetes and bone.Osteoporosis and sarcopenia · 2019
    Review
  17. Article
  18. Diagnosis and management of bone fragility in diabetes: an emerging challenge.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2018 · on this map
    Review
  19. Review
  20. 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

5 authors at 4 institutions in 1 country.

Daisuke InoueThird Department of Medicine, Teikyo University Chiba Medical Center, 3426-3, Anesaki, Ichihara-shi, Chiba, 299-0111, Japan. inoued@med.teikyo-u.ac.jp.
Ryoichi MuraokaData Science Group, Clinical Development Department, Ajinomoto Pharmaceuticals Co., Ltd., Tokyo, Japan.
Ryo OkazakiThird Department of Medicine, Teikyo University Chiba Medical Center, 3426-3, Anesaki, Ichihara-shi, Chiba, 299-0111, Japan.
Yoshiki NishizawaDepartment of Metabolism, Endocrinology, and Molecular Medicine, Graduate School of Medicine, Osaka City University, Osaka, Japan.
Toshitsugu SugimotoFirst Department of Internal Medicine, Faculty of Medicine, Shimane University, Matsue, Shimane, Japan.
Teikyo University Chiba Medical Center · JPAjinomoto (Japan) · JPOsaka City University · JPShimane University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Many osteoporotics have comorbid diabetes mellitus (DM), hypertension (HT), and dyslipidemia (DL). However, whether such comorbidities alter response to anti-osteoporotic treatment is unknown. We did post hoc analyses of combined data from three risedronate Japanese phase III trials to determine whether the presence of DM, HT, or DL affects its efficacy and safety. Data from 885 subjects who received 48-week treatment with risedronate were collected and combined from the three phase III trials. They were divided into two groups by the presence or absence of comorbidities: DM (n = 53) versus non-DM (n = 832); HT (n = 278) versus non-HT (n = 607); and DL (n = 292) versus non-DL (n = 593). Bone mineral density (BMD), urinary type 1 collagen N-telopeptide (uNTX), and serum bone-specific alkaline phosphatase (BAP) were measured at baseline and sequentially until 48 weeks. BMD or bone markers were not different between any of the two groups. Overall, BMD was increased by 5.52%, and uNTX and BAP were decreased by 35.4 and 33.8%, respectively. Some bone markers were slightly lower in DM and DL subjects, but the responses to risedronate were not significantly different. Statin users had lower uNTX and BAP, but showed no difference in the treatment response. All the other medications had no apparent effect. Adverse event incidence was marginally higher in DL compared with non-DL (Relative risk 1.06; 95% confidence interval 1.01-1.11), but was not related to increase in any specific events. Risedronate shows consistent safety and efficacy in suppressing bone turnover and increasing BMD in osteoporosis patients with comorbid DM, HT, and/or DL.

Indexed as

AdultAgedBone DensityBone Density Conservation AgentsComorbidityDiabetes MellitusDouble-Blind MethodDyslipidemiasFemaleHumansHypertensionJapanMaleMetabolic SyndromeMiddle AgedOsteoporosisBone Density Conservation AgentsRisedronic AcidBisphosphonateBone mineral densityBone turnover markersLife style-related diseaseMetabolic syndromeRisedronate

Identifiers

PMID26466937
PMCPMC4723633
OpenAlexW1951369680

What OpenQuestion holds

Textmetadata
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.