Evidence map›Paper›PMID 41743539›Full record

ArticleTherapeutic advances in musculoskeletal disease2026

Three-drug combination therapy to prevent glucocorticoid-associated osteonecrosis in patients with systemic lupus erythematosus: a proof-of-concept study.

Goro Motomura, Yojiro Arinobu, Hiroaki Niiro, Kazuoto Hiramoto, Yuko Kaneko, Masaru Kato, Shuhei Takeyama, Shunsuke Furuta, Hiroshi Nakajima, Ran Nakashima and 16 more

Abstract read
In one paragraph

Article in Therapeutic advances in musculoskeletal disease, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

26 authors.

Goro MotomuraDepartment of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.ORCID https://orcid.org/0000-0001-7470-8202
Yojiro ArinobuDepartment of Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Hiroaki NiiroDepartment of Medical Education, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Kazuoto HiramotoDivision of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Yuko KanekoDivision of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Masaru KatoDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Shuhei TakeyamaDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Shunsuke FurutaDepartment of Allergy and Clinical Immunology, Chiba University Hospital, Chiba, Japan.
Hiroshi NakajimaDepartment of Allergy and Clinical Immunology, Chiba University Hospital, Chiba, Japan.
Ran NakashimaDepartment of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Hajime YoshifujiDepartment of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Takeshi KurodaHealth Administration Center, Niigata University, Niigata, Japan.
Koichi AmanoDepartment of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Masakazu MatsushitaDepartment of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Tokyo, Japan.
Ken YamajiDepartment of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Tokyo, Japan.
Koshiro SonomotoDepartment of Clinical Nursing, School of Health Sciences, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
Yoshiya TanakaFirst Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
Naoko HimuroDivision of Nephrology and Rheumatology, Department of Internal Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
Katsuhisa MiyakeDivision of Nephrology and Rheumatology, Department of Internal Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
Akihito MaruyamaDepartment of Rheumatology, Faculty of Medicine, Saga University, Saga, Japan.
Yoshifumi TadaDepartment of Rheumatology, Faculty of Medicine, Saga University, Saga, Japan.
Atsushi NomuraDepartment of Rheumatology, Ushiku Aiwa General Hospital, Ushiku, Japan.
Masato OkadaImmuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan.
Junji KishimotoCenter for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.
Yasuharu NakashimaDepartment of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Takuaki YamamotoDepartment of Orthopaedic Surgery, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Systemic lupus erythematosus (SLE) is a major underlying disease of glucocorticoid-associated osteonecrosis of the femoral head (ONFH). Despite its clinical significance, no prophylactic treatment has been established to prevent ONFH in patients receiving systemic glucocorticoid therapy. Objectives: To investigate the efficacy and safety of a three-drug combination therapy consisting of clopidogrel sulfate, pitavastatin calcium hydrate, and tocopherol acetate, administered concurrently with initial glucocorticoid therapy to prevent ONFH in patients with SLE. Design: A multicenter, single-arm, interventional clinical trial conducted as an advanced medical treatment approved by the Ministry of Health, Labor and Welfare of Japan. Methods: This study was conducted at 12 sites in Japan between August 2014 and March 2024. Patients with SLE who required initial glucocorticoid therapy (⩾0.5 mg/kg/day of prednisolone) received the three study drugs concurrently with glucocorticoids for 90 days. Magnetic resonance imaging of both hip joints was performed 180 days after initiation of glucocorticoid therapy to determine ONFH occurrence. The primary endpoint was ONFH incidence, and safety and potential risk factors were also evaluated using logistic regression analysis. Results: Of the 50 enrolled patients, 43 completed the 90-day regimen. ONFH was identified in 8 of 43 patients (18.6%), which was below the threshold incidence of 25% based on the historical control, suggesting a potential signal of reduced incidence ( Conclusion: The findings demonstrate the feasibility and acceptable safety of this three-drug combination therapy. Although the results should be regarded as preliminary and hypothesis-generating, they suggest a potential signal that warrants further investigation in adequately powered randomized controlled trials. Trial registration: Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus (UMIN000008230; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009636).

Indexed as

glucocorticoidosteonecrosispreventionsystemic lupus erythematosus

Identifiers

PMID41743539
PMCPMC12929830

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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.