Clinical trial NCT03898024: Effects of SHR-1222 on Vascular Inflammatory Factors in Patients With Low Bone Mass
Official title: Effects of SHR-1222 on Vascular Inflammatory Factors in Patients With Low Bone Mass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis, Osteopenia
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Assessment of serum nitric oxide (NO) change after the administration of SHR-1222
timeFrame: Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
measure: Assessment of serum Endothelin-1 (ET-1) change after the administration of SHR-1222
timeFrame: Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
measure: Assessment of serum plasminogen activator inhibitor-1 (PAI-1) change after the administration of SHR-1222
timeFrame: Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
measure: Assessment of serum hypersensitivity C-reactive protein (hs-CRP) change after the administration of SHR-1222
timeFrame: Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Second Xiangya Hospital of Central South University
name: Zhiguang Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References: