To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women With Osteoporosis at High Fracture Risk

A Multicenter, Randomized, Open-label, Parallel Controlled, Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of SAL056 (Teriparatide for Injection ) in the Treatment of Postmenopausal Women With Osteoporosis at High Fracture Risk

To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women with Osteoporosis at High Fracture Risk

The trial consists of a screening period (4 weeks), an open-label treatment period (up to 48 weeks), and a follow-up period (1 weeks), totaling approximately 53 weeks. Subjects who withdraw early will be asked to complete an end of treatment visit, and a safety follow-up visit 2 weeks after the end of treatment visit.

Inclusion Criteria:

1. Postmenopausal women with the ability to live independently (≥45 and ≤80 years);
2. The patient has a body mass index(BMI) of 18.0 kg/m2 to 30 kg/m2； The patient has one of the following diagnostic criteria for osteoporosis and subject has at least 2 consecutive vertebrae region (L1 to L4) that are evaluable by dual-energy x-ray absorptiometry (DXA)，a) History of hip/vertebra fragility fracture and bone mineral density (BMD) T-score ≤-1; b）the axial bone (lumbar , femoral neck or total hip) mineral density (BMD) T-score ≤-2.50;c) Bone mineral density (BMD) T-score ≥-2.5 and ≤-1 with proximal humerus, pelvis, or distal forearm end fragility fracture

Exclusion Criteria:

1. In addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism;
2. Patients with other diseases affecting calcium or bone metabolism;
3. Received anti-osteoporosis treatment that does not meet protocol requirements;
4. Received medication that affects bone metabolism prior to screening, or is planned to use prohibited drugs/non-drug therapy under the protocol during the study period;
5. Patients requiring long-term or continuous use of digoxin and other digitalis drugs during the trial;
6. Patients with other severe underlying diseases； Patients with abnormal indicators that does not meet protocol requirements during the screening periodlaboratory tests