Bone · FDA Approved
Sclerostin Antibodies (Romosozumab)
FDA-approved
01 · Overview
Romosozumab is a humanized monoclonal antibody that binds and inhibits sclerostin, a glycoprotein produced by osteocytes that negatively regulates Wnt signaling. By blocking sclerostin it increases bone formation and decreases bone resorption (PMID 27641143).
It is marketed as Evenity and is listed in FDA approval records as a prescription biologic indicated for osteoporosis in postmenopausal women at high risk for fracture. It is given by subcutaneous injection.
02 · Research summary & key findings
In the FRAME trial, 7180 postmenopausal women received monthly romosozumab or placebo for 12 months followed by denosumab, and new vertebral fractures at 12 months occurred in 0.5 percent of romosozumab patients versus 1.8 percent of placebo patients (PMID 27641143). In the ARCH trial, 4093 women with osteoporosis and a fragility fracture were randomized to romosozumab or alendronate, and over 24 months the romosozumab-to-alendronate group had a 48 percent lower risk of new vertebral fracture, a 27 percent lower risk of clinical fracture, a 19 percent lower risk of nonvertebral fracture and a 38 percent lower risk of hip fracture (PMID 28892457). The current label carries a boxed warning about potential risk of myocardial infarction, stroke and cardiovascular death, and advises against initiation in patients with such an event in the preceding year.
03 · Regulatory status
Sclerostin Antibodies (Romosozumab) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
Sclerostin Antibodies (Romosozumab) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.
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Sclerostin Antibodies (Romosozumab) is prescribed for the conditions on its label, and it is not part of our intake. If you are working on injury recovery and tissue repair, a licensed clinician can tell you at a free consultation whether an FDA-approved or lawfully compounded treatment fits you, or whether nothing does.
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04 · Administration routes
- Subcutaneous injection
References
- [1]Romosozumab Treatment in Postmenopausal Women with Osteoporosis N Engl J Med, 2016. PMID 27641143
- [2]Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis N Engl J Med, 2017. PMID 28892457
Primary literature
- PubMed: "Sclerostin Antibodies"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Sclerostin Antibodies"
Registered interventional and observational studies, including status and phase.
- PubChem: "Sclerostin Antibodies"
Chemical structure, molecular properties, and bioactivity data.
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