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Romosozumab
FDA ApprovedSince 2019
Also known as Evenity
Function
Primary
Postmenopausal Osteoporosis
Mechanism
Anti-sclerostin monoclonal antibody — dual action: increases bone formation AND decreases resorption simultaneously.
Evidence
Clinical RCT (Phase III)
Research
Phase III FRAME / ARCH trials
Dosing
Range
210 mg/month
Frequency
Monthly (12 doses)
Route
Subcutaneous
Cycling
12 monthly doses, then transition to antiresorptive.
Benefits
- ·Rapid and substantial BMD gains
- ·Reduced vertebral and clinical fractures
- ·Short 12-month course
Risks
- ·MI/stroke (black box CV warning)
- ·Jaw osteonecrosis
- ·Atypical femoral fractures
- ·Hypocalcemia
Contraindications
- ·Recent MI or stroke (1 year)
- ·Hypocalcemia
Regulatory
FDA-Approved Rx
Functional Groups
Cited Works
- Cosman F et al. Romosozumab Treatment in Postmenopausal Osteoporosis (FRAME). N Engl J Med. 2016;375:1532.source