Osteoporosis, Osteopenia
Conditions
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.
Interventions
DRUGSHR-1222
Pharmaceutical form: water injection; Route of administration: subcutaneous
DRUGPlacebo
Pharmaceutical form: water injection; Route of administration: subcutaneous
Sponsors
Second Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 59 Years
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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of serum nitric oxide (NO) change after the administration of SHR-1222 | Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration | NO level will be detected by nitrite/nitrate assay (colorimetric). |
| Assessment of serum Endothelin-1 (ET-1) change after the administration of SHR-1222 | Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration | ET-1 level will be detected by ELISA. |
| Assessment of serum plasminogen activator inhibitor-1 (PAI-1) change after the administration of SHR-1222 | Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration | PAI-1 level will be detected by ELISA. |
| Assessment of serum hypersensitivity C-reactive protein (hs-CRP) change after the administration of SHR-1222 | Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration | hs-CRP level will be detected by immunoturbidimetry assay. |
Countries
China
Outcome results
None listed