Evidence map›Paper›PMID 23716037›Full record

Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2014

Effect of the cathepsin K inhibitor odanacatib administered once weekly on bone mineral density in Japanese patients with osteoporosis--a double-blind, randomized, dose-finding study.

T Nakamura, M Shiraki, M Fukunaga, T Tomomitsu, A C Santora, R Tsai, G Fujimoto, M Nakagomi, H Tsubouchi, E Rosenberg and 1 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00620113 (A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Dose-Finding Study of MK-0822 in the Treatment of Involutional Osteoporosis), which is not on this map. Cited by 17 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 3 pooled it
6.5field-weighted citation impact, top 3% 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.

NCT00620113 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Dose-Finding Study of MK-0822 in the Treatment of Involutional Osteoporosis

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2007 to 2009Enrolled287ConditionsOsteoporosis PostmenopausalArmsOdanacatib, Vitamin D3, Calcium carbonate, Placebo
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 44 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Efficacy of combined treatment with alendronate (ALN) and eldecalcitol, a new active vitamin D analog, compared to that of concomitant ALN, vitamin D plus calcium treatment in Japanese patients with primary osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2015
    Trial
  5. OptimizingPeerJ · 2026
    Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Effect of osteoporosis medications on fracture healing.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2016
    Review
  12. Article
  13. Multicentric reticulohistiocytosis: a critical review.Current rheumatology reports · 2015
    Review
  14. Chronic kidney disease and bone metabolism.Journal of bone and mineral metabolism · 2015
    Article
  15. Article
  16. Osteochemonecrosis: an overview.Head and neck pathology · 2014
    Review
  17. 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

11 authors at 4 institutions in 2 countries.

T NakamuraNational Center for Global Health and Medicine, Shinjuku-ku Tokyo, 162-8655, Japan, toshinak@med.uoeh-u.ac.jp.
M Shiraki
M Fukunaga
T Tomomitsu
A C Santora
R Tsai
G Fujimoto
M Nakagomi
H Tsubouchi
E Rosenberg
S Uchida
MSD K.K. (Japan) · JPKawasaki Medical School · JPMerck & Co., Inc., Rahway, NJ, USA (United States) · USNational Center for Global Health and Medicine · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledThe efficacy and safety of oral placebo or odanacatib 10, 25, or 50 mg once weekly for 52 weeks were evaluated in a double-blind, randomized, multi-center study in Japanese female and male patients with osteoporosis.

introductionOdanacatib is a selective and reversible cathepsin K inhibitor that decreases bone resorption and increases bone mineral density (BMD).

methodsThe primary efficacy endpoint was percent change from baseline to week 52 in lumbar spine BMD. Secondary endpoints included percent change in total hip, femoral neck, and trochanter BMD and in bone biomarkers after treatment for 52 weeks.

resultsIn this study, 286 patients [94% female, mean age (SD) 68.2 (7.1) years] were included in the analysis. The least-squares mean percent changes from baseline to week 52 in the groups receiving placebo, 10, 25 and 50 mg of odanacatib for lumbar spine (L1~L4) BMD were 0.5, 4.1, 5.7, and 5.9% and for total hip BMD were -0.4, 1.3, 1.8, and 2.7%, respectively. The changes in femoral neck and trochanter BMD were similar to those at the total hip. Bone turnover markers were reduced in a dose-dependent manner. However, the effects of odanacatib on bone formation markers were less compared with the effects on bone resorption markers. Tolerability and safety profiles were similar among all treatment groups with no dose-related trends in any adverse events.

conclusionsWeekly odanacatib treatment for 52 weeks increased BMD at the lumbar spine and at all hip sites in a dose-dependent manner and was well tolerated in Japanese patients with osteoporosis.

Indexed as

AgedAnthropometryBiomarkersBiphenyl CompoundsBone DensityBone Density Conservation AgentsCathepsin KDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHip JointHumansLumbar VertebraeMaleMiddle AgedBiomarkersBiphenyl CompoundsBone Density Conservation AgentsCathepsin Kodanacatib

Identifiers

PMID23716037
OpenAlexW2016160364

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.