Medical uses and indications - Used for osteoporosis at high risk for fractures - Used for bone loss due to certain medications - Used for those with bone metastases - Reduces the risk of fractures in those with cancer - Considered a reasonable treatment for postmenopausal osteoporosis
Adverse effects - Common side effects include joint and muscle pain in the arms or legs - Increased risk of infections such as cellulitis - Increased risk of hypocalcemia (low blood calcium) - Increased risk of hypersensitivity allergy reactions - Increased risk of osteonecrosis of the jaw and atypical femur fractures
Contraindications and interactions - Contraindicated in people with hypocalcemia - Requires sufficient calcium and vitamin D levels before starting therapy - Missing data regarding interactions with other drugs - May increase the risk of osteonecrosis of the jaw following dental procedures - Invasive dental procedures should be avoided during treatment
Mechanism of action - Bone remodeling is the process of removing old bone tissue and replacing it with new bone - Osteoclasts are cells responsible for breaking down bone - RANKL is a protein that promotes the maturation of osteoclasts - Denosumab inhibits the maturation of osteoclasts by binding to and inhibiting RANKL - Denosumab mimics the action of osteoprotegerin, a natural RANKL inhibitor
Regulatory approval - Approved by the FDA for use in postmenopausal women with risk of osteoporosis - Approved by the FDA for prevention of skeleton-related events in patients with bone metastases - First RANKL inhibitor to be approved by the FDA - Approved by the European Commission for the treatment of postmenopausal osteoporosis - Approved by the European Commission for the treatment of bone loss in men with hormone ablation therapy for prostate cancer