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Effects of SHR-1222 on Vascular Inflammatory Factors in Patients With Low Bone Mass | Clinical Trials | Clareo Health

COMPLETEDNA

Effects of SHR-1222 on Vascular Inflammatory Factors in Patients With Low Bone Mass

NCT03898024•Second Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

This study aims to investigate the effects of SHR-1222 on vascular inflammatory factors in patients with low bone mass.

Detailed Description

In this study, total 50 patients with low bone mass will be enrolled and divided into 5 dose groups. In the lowest dose group 6 subjects will be recruited, among whom 4 will receive SHR-1222 and the other 2 will receive placebo. In each of the other 4 groups, 11 subjects will be recruited, among whom 9 will be administered with SHR-1222 and the other 2 with placebo. Levels of nitric oxide (NO), Endothelin-1 (ET-1), plasminogen activator inhibitor-1 (PAI-1) and hypersensitivity C-reactive protein (hs-CRP) will be detected in patients before and after the SHR-1222 injection.

Eligibility

Age

45 - 59 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Signed informed consent;
•Male or postmenopausal female;
•Age ≥45 and ≤59 years old;
•The body mass index (BMI) ≥18.5kg/m2 and ≤28 kg/m2;
•T value of areal bone mineral density on any lumbar spine (L1-L4) or collum femoris\>-2.5 and \<-1;
•The comprehensive physical examination is eligible or slightly abnormal but the researchers determine no clinical implication;
•No smoking, alcohol or drugs abuse.

Exclusion Criteria

•Any disease affecting bone metabolism;
•Past medical history of cerebral infarction or cerebral arterial thrombosis;
•Past medical history of myocardial infarction;
•Administration of the following drugs within 6m: Hormone replacement therapy, Calcitonin Parathyroid hormone (or any derivative), Supplemental Vitamin D\>1,000 IU/day, Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed), Anabolic steroids, Calcitriol and available analogues, thiazide diuretics;
•Administration of the following drugs within 12m: Bisphosphonates, Fluoride for osteoporosis;
•A bone fracture within the previous 6 months;
•A lumbar spine L1-L4 or femoral neck T-score ≤-2.5;
•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT) or total bilirubin, more than 1.5 x ULN during screening;
•3 months prior to screening involved in any drug clinical subjects;
•Subjects determined by the researchers have any food, dietary supplement or drugs that affect SHR-1222 absorption, distribution, metabolism and excretion in 4 weeks prior to screening or within 5 half-lives;
+8 more criteria

Locations (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Key Dates

Start Date

April 15, 2019

Primary Completion Date

July 27, 2020

Completion Date

August 15, 2020

Last Updated

June 30, 2022

Enrollment

ACTUAL participants

Conditions

Osteoporosis, Osteopenia

Interventions

SHR-1222

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 30, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of SHR-1222 on Vascular Inflammatory Factors in Patients With Low Bone Mass

Inclusion Criteria

Exclusion Criteria

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