Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02791516 | A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis | PHASE3 | COMPLETED | 67 | — | — | Jan 16, 2017 | Dec 21, 2018 | Oct 7, 2019 | 10 | South Korea |
| NCT02016716 | A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis | PHASE3 | COMPLETED | 294 | — | — | Dec 3, 2013 | Dec 8, 2014 | Nov 8, 2018 | 12 | United States, Czechia +1 |
| NCT01575834 | Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis | PHASE3 | COMPLETED | 7,180 | — | — | Mar 15, 2012 | Dec 28, 2016 | Aug 28, 2024 | 218 | United States, Argentina +22 |
Bone mineral density (BMD) at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method. The Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale: * Grade 0 (Normal) = no fracture; * Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); * Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; * Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.
New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method. The Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale: * Grade 0 (Normal) = no fracture; * Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); * Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; * Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo subcutaneous injection once a month for 6 months. |
| Romosozumab | EXPERIMENTAL | Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months. |
| Romosozumab 90 mg/mL | EXPERIMENTAL | Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous (SC) 1.17 mL injections of a 90 mg/mL solution, for 6 months. |
| Placebo 90 mg/mL | EXPERIMENTAL | Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months. |
| Romosozumab 70 mg/mL | EXPERIMENTAL | Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1.0 mL injections of a 70 mg/mL solution, for 6 months. |
| Placebo 70 mg/mL | PLACEBO_COMPARATOR | Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months. |
| Name | Type | Description |
|---|---|---|
| Romosozumab | DRUG | Administered by subcutaneous injection once a month (QM) |
| Placebo | DRUG | Administered by subcutaneous injections once a month |
| Romosozumab 90 mg/mL | DRUG | Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS). |
| Placebo 90 mg/mL | DRUG | Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS. |
| Romosozumab 70 mg/mL | DRUG | Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS. |
| Placebo 70 mg/mL | DRUG | Placebo administered as 3 SC injections with the 1.0 mL glass PFS. |
| Denosumab | DRUG | Administered by subcutaneous injection once every 6 months (Q6M) |
Inclusion Criteria: * Ambulatory postmenopausal Korean women, ≥ 55 to ≤ 90 years of age at enrollment. * Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more consecutive months prior to screening. * BMD T-score \</= -2.50 at the lumbar spine, total hip or femoral n...