Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Romosozumab Prefilled Syringe [Evenity], Romosozumab Prefilled Syringe, Romosozumab
Romosozumab/mL · 3 trials · 1 indication
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...
Romosozumab is a monoclonal antibody being developed for musculoskeletal conditions including postmenopausal osteoporosis, osteogenesis imperfecta, osteopenia, and premenopausal idiopathic osteoporosis. It is currently in Phase 2 clinical development for premenopausal idiopathic osteoporosis, with earlier studies completed in osteopenia.
Romosozumab is developed by Amgen Inc., traded on NASDAQ under the ticker AMGN. The company is conducting clinical trials to evaluate the drug for osteoporosis-related conditions.
Romosozumab is in Phase 2 clinical development. One active Phase 2 trial is studying the drug in premenopausal idiopathic osteoporosis, while three Phase 1 trials have been completed in osteopenia. It is investigational and not yet approved.
Romosozumab has four clinical trials. The active Phase 2 trial is NCT04800367 for premenopausal idiopathic osteoporosis. Completed Phase 1 trials include NCT00950950, NCT01059435, and NCT01101061, all studying osteopenia in postmenopausal women or healthy participants.
Romosozumab is also known as Romosozumab Prefilled Syringe [Evenity] and Romosozumab Prefilled Syringe. These names refer to the same drug product, which is being developed by Amgen for osteoporosis-related conditions.