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

Osteoporosis, Osteopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898024
• Other study ID #: 2019 SHR-1222
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: August 15, 2020

Study information

• Verified date: June 2022
• Source: Second Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 15, 2020
• Est. primary completion date: July 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 59 Years

Eligibility

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;
• Serious infection, trauma or major surgery in 4 weeks prior to screening;
• A surgery plan during the study;
• Blood donation and transfusion in 3 months prior to screening;
• Unstable thyroid dysfunction in 6 months prior to screening;
• Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
• Intolerant to venous blood collection;
• A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar;
• Subjects with any other situation should not be involved, which determined by the researchers.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteoporosis
• Osteoporosis, Osteopenia

Intervention

Drug:
• SHR-1222
Pharmaceutical form: water injection; Route of administration: subcutaneous
• Placebo
Pharmaceutical form: water injection; Route of administration: subcutaneous

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of serum nitric oxide (NO) change after the administration of SHR-1222	NO level will be detected by nitrite/nitrate assay (colorimetric).	Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
Primary	Assessment of serum Endothelin-1 (ET-1) change after the administration of SHR-1222	ET-1 level will be detected by ELISA.	Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
Primary	Assessment of serum plasminogen activator inhibitor-1 (PAI-1) change after the administration of SHR-1222	PAI-1 level will be detected by ELISA.	Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
Primary	Assessment of serum hypersensitivity C-reactive protein (hs-CRP) change after the administration of SHR-1222	hs-CRP level will be detected by immunoturbidimetry assay.	Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration