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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
493
Administered by subcutaneous injection once a week during treatment phase
70 mg tablet taken once a week during treatment phase
Shanghai Sixth People's Hosptital
Shanghai, China
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks
Time frame: Baseline to 48 Weeks
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 24 Weeks
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 24 Weeks
Time frame: Baseline to 24 Weeks
Percent Change in Bone Mineral Density (BMD) of Total Hip from Baseline to 24/48 Weeks
Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to 24/48 Weeks
Time frame: Baseline to 24/48 Weeks
Percent Change in S-CTX and P1NP From Baseline to12/ 24/48 Weeks
Percent Change in S-CTX and P1NP From Baseline to 12/24/48 Weeks
Time frame: Baseline to 12/24/48 Weeks
Proportion of Subjects with New Fragility Fractures from Baseline to 24/48 Week
Proportion of Subjects With New Fragility Fractures from Baseline to 24/48 Weeks
Time frame: Baseline to 24/48 Weeks
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