Bazedoxifene for the treatment of osteoporosis

ABSTRACT

Introduction: Bazedoxifene (BZD) is a third-generation selective estrogen receptor modulator approved for the treatment of postmenopausal osteoporosis with additional favorable effects in lipids, uterine and breast tissue.

Areas covered: In this review, the authors outline clinical data regarding the efficacy, safety, and tolerability of continuous BZD administration up to seven years in randomized, placebo-controlled, phase III clinical trials. Long-term treatment with BZD for postmenopausal osteoporosis is generally safe and well tolerated. BZD achieves small but significant increases in the bone mineral density of the lumbar spine but not the total hip. In addition, BZD reduces significantly the risk of vertebral fractures but not of non-vertebral and hip fractures, with the exception of high fracture risk postmenopausal women in whom BZD significantly reduces non-vertebral fractures.

Expert opinion: BZD does not seem to offer significant advantages over the other available antiresorptive agents. However, considering the need for long-term management of osteoporosis, BZD may have a place in the long-term therapeutic planning of the disease.

KEYWORDS:

• Bazedoxifene
• fracture
• osteoporosis
• SERM

Article highlights

• Bazedoxifene is a third generation selective estrogen receptor modulator approved for the management of postmenopausal osteoporosis.

• It has been shown to exert additional favorable effects on lipid profile, breast and uterine tissue.

• It is generally considered a safe and well-tolerated drug, although not as efficacious as other anti-osteoporotic agents, and can be used as a sequential treatment in the long-term management of osteoporosis.

• The combination of bazedoxifene with conjugated estrogens shows additive bone effects of the two compounds with an additional positive effect on menopausal symptoms, while avoiding the need for progestin.

Declaration of interest

AD Anastasilakis has received lecture fees from Amgen Inc, Eli Lilly and Company, ITF Hellas, Elpen and Vianex. He also was investigator in the ARCH study. P Makras has received lecture fees and research grants from Amgen Inc and Gilead Sciences. He has also received lecture fees from GlaxoSmithKline, Eli Lilly and Company, Pfizer Inc, Leo Pharm, Genesis, Elpen, Vianex, and Rafarm SA and was also investigator in the ARCH study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

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Funding

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