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

Salubris Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Women With Osteoporosis

Treatments: Drug: Alendronate; Drug: SAL056 (56.5μg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07028320

SAL056A301

Details and patient eligibility

About

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

Full description

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.

Enrollment: 493 patients

Sex: Female

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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493 participants in 2 patient groups

Drug: SAL056 (56.5μg)

Experimental group

Description:

Administered by subcutaneous injection once a week during treatment phase

Treatment:

Drug: SAL056 (56.5μg)

Drug: Alendronate

Active Comparator group

Description:

70 mg tablet taken once a week during treatment phase

Treatment:

Drug: Alendronate