May 8, 2019
Romosozumab-aqqg (Evenity) Approved for Treatment of Osteoporosis: In April 2019, the US. Food and Drug Administration (FDA) approved romosozumab-apqg to treat osteoporosis in postmenopausal women at high risk of fracture. The monoclonal antibody blocks the effects of the protein sclerostin and primarily stimulates new bone formation, although it also has antiresorptive activity. Two phase 3 clinical trials demonstrated reductions in bone fractures after 12 months when compared to placebo and to oral alendronate 70 mg daily. The labeling contains a boxed warning that it may increase the risk of MI, stroke and cardiovascular death, which may limit use of the drug because the target population is older women who may be at higher cardiovascular risk. Romosozumab-apqg offers a novel anabolic treatment strategy for women who are at high risk of osteoporotic fracture but is expensive, with a U.S. list price reported to be $21,900 for a full 12-month course of injections.
August 31, 2017
Updated Guidelines for Prevention and Treatment of Glucocorticoid-Induced Osteoporosis: The American College of Rheumatology (ACR) updated its previous 2010 recommendations for preventing and treating glucocorticoid-induced osteoporosis (GIOP). An expert panel performed a systematic review involving patients taking systemic glucocorticoids (prednisone >2.5 mg/day) for ≥3 months. The guidelines address initial assessment and reassessment of patients starting or continuing glucocorticoid treatment and the relative benefits and risks of lifestyle changes and use of calcium, vitamin D, bisphosphonates, raloxifene, teriparatide, and denosumab in adults and select special populations.
June 2, 2017
Abaloparatide for Treatment of High-Risk Postmenopausal Osteoporosis: Abaloparatide (TymlosTM) is a synthetic analog of human parathyroid hormone (PTH) related peptide acting as an anabolic agent to stimulate bone formation. It is FDA-approved for treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as multiple risk factors for fracture or a history of osteoporotic fracture) or patients who have failed or are intolerant to other therapies. The Phase 3 controlled ACTIVE Trial demonstrated reduced new vertebral and nonvertebral fractures and increased bone mineral density after 18 months with abaloparatide compared with placebo. There are no controlled trials comparing abaloparatide with teriparatide or other agents. When abaloparatide is discontinued, antiresorptive treatment should be considered as sequential therapy to protect against bone loss.
CHAPTER SUMMARY FROM THE PHARMACOTHERAPY HANDBOOK
For the chapter in the Wells Handbook, please go to Chapter 3. Osteoporosis.
Osteoporosis is a public health epidemic that affects all ages, genders, races, and ethnicities. Lifestyle behaviors, diseases, and medications should be reviewed to identify risk factors for developing osteoporosis and osteoporotic fractures. Healthcare providers should identify and resolve reversible risks. Patients with early onset or severe osteoporosis should be evaluated for secondary causes of bone loss.
Bone physiology and pathophysiology are complex, involving many different cell lines, pathways, and ...