Efficacy and Safety of JMT103 in the Treatment of Glucocorticoid Induced Osteoporosis

Inclusion Criteria: * 1\. Both genders aged 18 years or above, capable of autonomous action; * 2\. In the course of an ongoing glucocorticoid treatment for at least 3months with prednisone≥7.5 mg or its equivalent taken currently, and expected to be treated of no less than 6 months in total; * 3\. Any of the followings: a. History of osteoporotic fracture; b. Age≥50 years and lumbar (L1-L4) or total hip BMD of T≤-2.0 by DXA; c. Age≥40 years and a predicted 10-year risk of major osteoporotic fractures ≥ 10% (vertebral body, forearm, hip, shoulder) or a predicted 10-year risk of hip fracture ≥ 1% estimated by hormone adjusted FRAX; * 4\. At least two lumbar vertebrae from L1 to L4 evaluable by DXA; * 5\. Uncompromised ability to maintain good communication with investigator and comply with all required study procedures; * 6\. A signed informed consent under the capability of thorough understanding. Exclusion Criteria: * 1\. Currently pregnant or lactating; For those of child bearing potential, refusal to use effective forms of contraception from signing informed consent to 6 months after last administration; * 2\. Previous or ongoing osteomyelitis or necrosis of jaw; Unhealed dental/oral operation wound; Acute jaw bone or dental disease requiring oral surgery; Planned invasive dental surgery during the study period; * 3\. Selected into other clinical studies of which the latest administration is less than 4 weeks (or 5 elimination half-lives, whichever is longer) from the first administration in this study; * 4\. Intravenous use of bisphosphonates, fluoride or strontium in the past 5 years; Oral bisphosphonates use for more than 3 years in total, or between 3 months to 3 years in total with the last medication used in the past 1 year prior to signing informed consent; * 5\. Receptor Activator for Nuclear Factor-κ B Ligand (RANKL) antibody used within 6 months prior to screening; * 6\. Administration of any of the following bone metabolism affecting drugs within 3 months prior to screening: a. Parathyroid hormone (PTH) or PTH derivatives (e.g., teriparatide); b. Anabolic hormones or testosterone; c. Sex hormone replacement; d. Selective estrogen receptor modulators (SERMs, e.g., raloxifene); e. Calcitonin; f. Other bone metabolism activating drugs include anticonvulsants (except benzodiazepines) and heparin; g. Long-term systemic use of ketoconazole, adrenocorticotropic hormone (ACTH), cinacalcet, aluminium, lithium, protease inhibitor, methotrexate or gonadotropin releasing hormone agonist; * 7\. Administration of any of the following biologic agents within 4 weeks prior to screening: a. Anti-alpha 4 integrin antibody (e.g., natalizumab); b. Anti CD4/CD8 T-cells (e.g., alefacept); c. Anti-IL12/anti-IL23 (e.g., ustekinumab); d. CTLA4 inhibitor (e.g., abatacept); e. IL1 receptor antagonist (e.g., anakinra); f. IL6 inhibitor (e.g., tocilizumab); g. Monoclonal antibody to CD20 (e.g., rituximab); h. TNF antagonist (e.g., adalimumab, certolizumab, golimumab, etanercept, infliximab); * 8\. Requirement of \>1 biologic agent (other than trial drug) for the treatment of underlying inflammatory disease; * 9\. Bone metabolic disorders (other than osteoporosis alone): a. Hypo- or hyperparathyroidism; b. Osteogenesis imperfecta; c. Malignant tumor; d. Hypopituitarism; e. Hyperprolactinemia; f. Acromegaly; g. Paget disease of bone; * 10\. Hyperthyroidism or hypothyroidism, except for a stable replacement therapy for at least 3 months turning out a normal ranged TSH or increased TSH≤10.0 μIU/mL with normal ranged FT4; * 11\. Malabsorption syndrome or various gastrointestinal diseases associated with malabsorption, such as Crohn's disease and chronic pancreatitis * 12\. Liver cirrhosis or unstable liver disease (defined as ascites, hepatic encephalopathy, coagulation disorder, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice); Known or clinically significant biliary abnormalities judged by investigator (except Gilbert syndrome, asymptomatic gallstones and gallbladder polyps); * 13\. Previous organ or bone marrow transplantation; * 14\. Unwilling to take vitamin D and calcium supplements as the procedure requires; * 15\. Uncontrolled concurrent diseases, including but not limited to: uncontrolled diabetes (\> 2 grade according to NCI-CTCAE5.0), symptomatic congestive heart failure, hypertension with blood pressure greater than 150/90 mmHg after standard treatment, unstable angina pectoris, arrhythmia requiring medication or instrument treatment, myocardial infarction history within 6 months, and echocardiography with left ventricular ejection fraction \< 50%; * 16\. 25\[OH\] vitamin D level \< 20 ng/mL, retest allowed after 5000 iu/day vitamin D added for 4-6 weeks; * 17\. Current hypocalcemia or hypercalcemia, defined as albumin-corrected serum calcium level of ≤ 2.2 mmol/L (8.8 mg/dL) or ≥ 2.9 mmol/L (11.5 mg/dL) (no supplementation of calcium for at least 8 hours before test); * 18\. Serum whole parathyroid hormone (iPTH) \> 65 pg/mL; * 19\. Any of the followings: a. Routine blood test (shall no treatment such as blood transfusion or hematopoietic stimulating factor was received within 7 days): absolute neutrophil count \< 1.5×10\^9/L, platelet \< 75 × 10\^9/L, or hemoglobin \< 90 g/L; b. Liver function test: total bilirubin \> 1.5 × upper limit of normal value (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 × ULN (retest allowed after 2-4 weeks for AST and ALT); c. Renal function test: estimated glomerular filtration rate (eGFR) \< 35 L/(min·1.73m\^2); d. Coagulation function test: activated partial thromboplastin time \> 1.5 × ULN, or international normalized ratio (INR) \> 1.5 × ULN; * 20\. Active bacterial or fungal infections requiring systematic treatment within 7 days prior to randomization; * 21\. HIV infection, active hepatitis, known or suspected active tuberculosis; * 22\. Any malignant tumor within 5 years prior to screening, except those expected to be cured (e.g., completely resected in situ skin basal cell or squamous cell carcinoma, cervical cancer or breast ductal cancer, etc.); * 23\. Known allergic/hypersensitive reaction or intolerance to JMT103, positive control drug, calcium and vitamin D; * 24\. Contraindicated to alendronate therapy: abnormalities of the esophagus which delay esophageal emptying (e.g., stricture or achalasia), or inability to stand or sit upright for at least 30 minutes; * 25\. BMD measurement by DXA interrupted: \< 2 measurable lumbar vertebrae; Interrupting height, weight or waist circumference; Severe scoliosis and other measurement affecting conditions; * 26\. Considered unsuitable for the research project by investigator.