BoneFDA Approved

Sclerostin Antibodies (Romosozumab)

Subcutaneous injection

Overview

Romosozumab is a humanized monoclonal antibody that binds and inhibits sclerostin, a glycoprotein produced by osteocytes that negatively regulates the Wnt signaling pathway. By blocking sclerostin, romosozumab increases Wnt pathway activity in osteoblasts, simultaneously promoting bone formation and reducing bone resorption.

Mechanism of Action

This dual mechanism produces rapid and substantial increases in bone mineral density. The antibody is composed of two heavy and two light immunoglobulin chains in a standard IgG2 configuration..

Research Summary & Key Findings

Romosozumab received FDA approval in 2019 based on the FRAME and ARCH trials, which demonstrated significant reductions in vertebral, clinical, and hip fractures in postmenopausal women with osteoporosis. The ARCH trial (NEJM, 2017) showed superior fracture reduction compared to alendronate over 24 months. A boxed warning was added regarding cardiovascular risk, including myocardial infarction and stroke, based on numerical imbalances observed in the ARCH study.

Clinical Status

FDA Approved

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.

Administration Routes

Subcutaneous injection

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol.