Evidence map›Paper›PMID 37091850›Full record

Trial reportFrontiers in endocrinology2023

Multiple doses of SHR-1222, a sclerostin monoclonal antibody, in postmenopausal women with osteoporosis: A randomized, double-blind, placebo-controlled, dose-escalation phase 1 trial.

Zhijie Dai, Ronghua Zhu, Zhifeng Sheng, Guijun Qin, Xianghang Luo, Qun Qin, Chunli Song, Liping Li, Ping Jin, Guoping Yang and 23 more

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Frontiers in endocrinology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 28% 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

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. 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

33 authors at 11 institutions in 1 country.

Zhijie DaiNational Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China.
Ronghua ZhuPhase I Clinical Trial Center and Department of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha, China.
Zhifeng ShengNational Clinical Research Center for Metabolic Diseases, Hunan Provincial Key Laboratory of Metabolic Bone Diseases, Department of Metabolism and Endocrinology, and Health Management Center, The Second Xiangya Hospital of Central South University, Changsha, China.
Guijun QinDepartment of Endocrinology and Metabolism, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Xianghang LuoDepartment of Endocrinology, Xiangya Hospital of Central South University, Changsha, China.
Qun QinNational Agency for Clinical Trial of Medicines, Xiangya Hospital of Central South University, Changsha, China.
Chunli SongOrthopedics Department, Peking University Third Hospital, Beijing, China.
Liping LiEndocrine Department, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China.
Ping JinDepartment of Endocrinology, The Third Xiangya Hospital of Central South University, Changsha, China.
Guoping YangCenter of Clinical Pharmacology, The Third Xiangya Hospital of Central South University, Changsha, China.
Yanxiang ChengDepartment of Gynecology, Renmin Hospital of Wuhan University, Wuhan, China.
Danhong PengDepartment of Gynaecology and Obstetrics, Zhongda Hospital Southeast University, Nanjing, China.
Chong ZouDepartment of Clinical Pharmacology, Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.
Lijuan WangDepartment of Endocrinology, Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.
Jianzhong ShentuClinical Pharmacy, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Qin ZhangDepartment of Geriatrics, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Zhe ZhangEndocrinology and Metabolism, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Xiang YanNational Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China.
Pingfei FangPhase I Clinical Trial Center and Department of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha, China.
Qiangyong YanPhase I Clinical Trial Center and Department of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha, China.
Lingfeng YangNational Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China.
Xiao FanPhase I Clinical Trial Center and Department of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha, China.
Wei LiuNational Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China.
Bo WuNational Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China.
Rongrong CuiNational Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China.
Xiyu WuNational Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China.
Yuting XieNational Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China.
Chang ShuClinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
Kai ShenClinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
Wenhua WeiClinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
Wei LuClinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
Hong ChenClinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
Zhiguang ZhouNational Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, China.
Central South University · CNJiangsu Hengrui Medicine (China) · CNSecond Xiangya Hospital of Central South University · CNFirst Affiliated Hospital Zhejiang University · CNJiangsu Province Hospital · CNFirst Affiliated Hospital of Henan University of Science and Technology · CNFirst Affiliated Hospital of Zhengzhou University · CNPeking University Third Hospital · CNRenmin Hospital of Wuhan University · CNThird Xiangya Hospital · CNZhongda Hospital Southeast University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

SHR-1222, a novel humanized monoclonal antibody targeting sclerostin, has been shown to induce bone formation and decrease bone resorption at a single dose ranging 50-400 mg in our previous phase 1 trial. This study was a randomized, double-blind, placebo-controlled, dose-escalation phase 1 trial, which further investigated the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of multiple ascending doses of SHR-1222 in women with postmenopausal osteoporosis (POP). A total of 105 women with POP were enrolled and randomly assigned. Twenty-one received placebo and eighty-four received SHR-1222 sequentially (100 mg QM, n=4; 200 or 300 mg QM, n=20; and 400 or 600 mg Q2M, n=20). The most common adverse events included increased blood parathyroid hormone, increased low-density lipoprotein, increased blood alkaline phosphatase, increased blood cholesterol, back pain, and arthralgia, the majority of which were mild in severity without noticeable safety concerns. Serum SHR-1222 exposure (C

Indexed as

Bone ResorptionOsteoporosis, PostmenopausalAlkaline PhosphataseAntibodies, MonoclonalBone DensityCollagen Type IFemaleHumansPostmenopauseAlkaline PhosphataseAntibodies, MonoclonalCollagen Type IProcollagen Type Ibone mineral densitypharmacodynamicspharmacokineticspostmenopausal osteoporosissclerostin

Identifiers

PMID37091850
PMCPMC10116854
OpenAlexW4362634558

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.