About this trial
This is a multicenter, randomized, open-label, parallel-controlled Phase II study designed to evaluate the differences in safety among four different dosing regimens of SAL056.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Received teriparatide treatment within 1 month prior to screening;
Patients with secondary osteoporosis, such as Cushing's syndrome, hyperprolactinemia, malabsorption syndrome or various gastrointestinal diseases related to malabsorption (such as Crohn's disease, chronic pancreatitis, etc.), rheumatoid arthritis, gout, multiple myeloma, etc.;
Patients with other diseases affecting calcium or bone metabolism, including hyperparathyroidism or hypoparathyroidism, hyperthyroidism or hypothyroidism (patients with hyperthyroidism or hypothyroidism receiving stable treatment with normal hormone levels are eligible; or patients with hypothyroidism where 5.5 mIU/L < thyroid-stimulating hormone ≤ 10.0 mIU/L but free thyroxine is within normal range are eligible), osteogenesis imperfecta, osteomalacia, Paget's disease of bone, hypercalcemia, hypocalcemia, active urolithiasis, etc.;
Patients who require treatment with other anti-osteoporosis drugs during the trial or long-term/continuous use of digitalis glycosides such as digoxin;
Trial design
Parallel
Treatments tested in this trial
SAL056 56.5μg
DrugSAL056 56.5μg administered once weekly for 8 weeks
Intervention Group 1
DrugTeriparatide Injection daily formulation administered for 2 weeks, followed by SAL056 for 6 weeks.
Intervention Group 2
DrugTeriparatide Injection daily formulation administered for 4 weeks, followed by SAL056 for 4 weeks.
Intervention Group 3
DrugSAL056 28.2μg administered twice weekly for 8 weeks.
Treatment groups
Trial outcomes
Primary outcomes
The incidence of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) between each intervention group and the control group during the treatment period,about 10weeks
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Lead sponsor
Salubris (Suzhou) Pharmaceutical Co., Ltd.
Collaborator