From the Guidelines
Romosozumab is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, particularly those who have failed or are intolerant to other osteoporosis therapies. The standard regimen consists of 210 mg administered as two subcutaneous injections once monthly for 12 months, followed by transition to an antiresorptive therapy such as alendronate or denosumab to maintain bone density gains 1.
Key Points
- Romosozumab works through a dual mechanism of action by both increasing bone formation and decreasing bone resorption, making it particularly effective for rapid increases in bone mineral density.
- It is most appropriate for patients with very low bone mineral density (T-score ≤ -2.5) and/or a history of fragility fractures, especially vertebral fractures.
- Romosozumab should not be used in patients with a history of myocardial infarction or stroke within the preceding year due to potential cardiovascular risks 1.
- Before initiating therapy, patients should have adequate calcium and vitamin D levels, and hypocalcemia should be corrected.
- Common side effects include arthralgia, headache, and injection site reactions.
- Due to its bone-building properties, romosozumab is typically used as a one-time, 12-month course rather than as a long-term therapy 1.
Considerations
- The use of romosozumab should be limited to 12 monthly doses because the anabolic effect wanes after 12 monthly doses 1.
- The analysis of the FDA Adverse Event Reporting System suggested higher risk for major adverse cardiovascular events associated with romosozumab 1.
- Higher risk for venous thromboembolism and fatal stroke in females who have documented coronary heart disease or are at increased risk for major coronary events 1.
From the FDA Drug Label
- 1 Treatment of Osteoporosis in Postmenopausal Women
Study 1 (NCT01575834) was a randomized, double-blind, placebo-controlled study of postmenopausal women aged 55 to 90 years (mean age of 71 years) with bone mineral density (BMD) T-score less than or equal to −2. 5 at the total hip or femoral neck.
The indications for Romosozumab are for the treatment of osteoporosis in postmenopausal women.
- Specifically, it is indicated for women with a bone mineral density (BMD) T-score less than or equal to −2.5 at the total hip or femoral neck.
- The goal of treatment is to reduce the incidence of new vertebral fractures and increase bone mineral density.
- Romosozumab has been shown to significantly reduce the incidence of new vertebral fractures through month 12 compared to placebo, and this reduction in fracture risk persists through the second year in women who receive romosozumab during the first year and transition to denosumab 2.
From the Research
Romosozumab Indications
- Romosozumab is indicated for the treatment of osteoporosis in postmenopausal women at high risk of fracture 3, 4, 5, 6, 7.
- The medication is approved for use in several countries, including the EU and the USA, for treating severe osteoporosis and osteoporosis in postmenopausal women at high risk of fracture 5, 7.
Patient Population
- Romosozumab is suitable for postmenopausal women with osteoporosis and mild-to-moderate chronic kidney disease 3.
- The medication can be considered a treatment option for postmenopausal women at very high risk for osteoporotic fracture 4.
Efficacy
- Romosozumab has been shown to significantly reduce vertebral and clinical fracture risk versus placebo and oral alendronate in postmenopausal women with osteoporosis 5, 6, 7.
- The medication increases bone mineral density (BMD) at the lumbar spine, femoral neck, and total hip in patients with osteoporosis 5, 6, 7.
Safety Profile
- Romosozumab has a generally manageable tolerability profile, but there is a potential risk of cardiovascular events 4, 6, 7.
- Hypocalcemia must be corrected prior to initiation of romosozumab 7.
- Clinicians should avoid romosozumab in patients with a history of myocardial infarction or stroke in the past 12 months 6.