Romosozumab is used to treat osteoporosis.
Romosozumab (brand name Evenity) is a humanized monoclonal antibody that targets sclerostin, a protein that naturally inhibits bone formation.
Unlike most osteoporosis drugs that only slow bone loss, romosozumab has a dual effect:
By blocking sclerostin, it activates the Wnt signaling pathway, which speeds up the activity of bone-building cells, osteoblasts.
It simultaneously slows down the cells that break down bone (osteoclasts).
It markedly increases bone formation and moderately reduces bone resorption.
Indications: It is primarily approved for postmenopausal women at a very high risk of osteporotic fracture.
The standard dose is 210 mg (given as two separate 105 mg injections) once a month.
Duration: Treatment is limited to 12 months because its bone-building effects wane after one year.
It is typically followed by an anti-resorptive agent, like denosumab or bisphosphonates, to maintain the newly built bone density.
Boxed Warning for a potential increased risk of heart attack, stroke, and cardiovascular death.
The drug should not be initiated in patients who have had a myocardial infarction or stroke in the past year.
Common Side Effects: These include joint pain and headache.
Rare but serious risks include hypocalcemia and osteonecrosis of the jaw.
It increases bone formation and decreases bone resorption in postmenopausal women with low bone density.
It decreases the risk of fractures of the spine.
Pregnancy category US: N (Not classified yet)Side effect include: headache, joint pain, and pain at the site of injection, increased the risk of heart attacks, strokes, and deaths from cardiovascular disease.
Two trials found a reduction rate of vertebral fracture: 73% and 50% lower risk of vertebral fracture after one year of treatment.
Anabolic medications, such as parathyroid hormone analogs or romosozumab should be considered as the first line agent in those at very high fracture risk for postmenopausal females with a T score of -2.5 or less for bone mineral density and prior fractures or those with multiple vertebral fractures.