Postmenopausal Women With Osteoporosis
Conditions
Keywords
Postmenopausal Women With Osteoporosis; Teriparatide
Brief summary
To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women with Osteoporosis at High Fracture Risk
Detailed 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.
Interventions
DRUGSAL056 (56.5μg)
Administered by subcutaneous injection once a week during treatment phase
DRUGAlendronate
70 mg tablet taken once a week during treatment phase
Sponsors
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks | Baseline to 48 Weeks | Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in S-CTX and P1NP From Baseline to12/ 24/48 Weeks | Baseline to 12/24/48 Weeks | Percent Change in S-CTX and P1NP From Baseline to 12/24/48 Weeks |
| Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 24 Weeks | Baseline to 24 Weeks | Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 24 Weeks |
| Percent Change in Bone Mineral Density (BMD) of Total Hip from Baseline to 24/48 Weeks | Baseline to 24/48 Weeks | Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to 24/48 Weeks |
| Proportion of Subjects with New Fragility Fractures from Baseline to 24/48 Week | Baseline to 24/48 Weeks | Proportion of Subjects With New Fragility Fractures from Baseline to 24/48 Weeks |
Countries
China
Outcome results
None listed