The FDA and two of its advisory committees have been debating whether to recommend limiting the duration of use of bisphosphonates in order to prevent atypical femoral fractures and possibly other side effects of the drugs. The agency produced a 182-page background document on this subject for a joint meeting of the Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committees held on September 9, 2011 (www.fda.gov). The document concluded that there is no clear evidence, with regard to fractures, of benefit or harm in continuing the drugs beyond 3-5 years. The two...

Radium Ra 223 dichloride (Xofigo – Bayer), a radiotherapeutic drug, has been approved by the FDA for intravenous treatment of castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease.

The FDA has approved romosozumab-aqqg (Evenity – Amgen), a sclerostin inhibitor, for once-monthly subcutaneous (SC) treatment of osteoporosis in postmenopausal women who are at high risk for fracture (history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or cannot tolerate other drugs for this indication. Romosozumab is the first sclerostin inhibitor to be approved in the US and the third drug for treatment of postmenopausal osteoporosis that stimulates bone formation; the parathyroid hormone (PTH) receptor agonists abaloparatide (Tymlos) and...

A 10-year study of daily oral alendronate (Fosamax) and a 7-year study of daily oral risedronate (Actonel) indicate that both drugs maintained increases in bone mineral density (BMD) and decreases in markers of bone remodeling throughout the study period. Both drugs are now more commonly taken once weekly. Available data are insufficient to compare fracture rates with alendronate and risedronate, and fracture rates are considered the most important endpoint in osteoporosis studies. Recent reports of severe pain and jaw osteonecrosis with these drugs are disturbing.

Ibandronate (Boniva - Roche) is the first bisphosphonate approved by the FDA for intravenous (IV) treatment of osteoporosis in postmenopausal women. It is given as a bolus injection once every 3 months. Ibandronate is also available as an oral once-a-month 150-mg tablet and as a daily 2.5-mg tablet.