effects of shr-1222 on vascular inflammatory factors in patients with low bone mass

Conditions: Osteoporosis, Osteopenia

Summary: this study aims to investigate the effects of shr-1222 on vascular inflammatory factors in patients with low bone mass.

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.