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.

Ibandronate (Boniva - Roche/GSK), a new oral bisphosphonate, was recently approved by the FDA in a once-monthly formulation for prevention and treatment of postmenopausal osteoporosis. The drug was initially approved in 2003 as a daily tablet, but was not marketed. An intravenous formulation for use once every 3 months is under investigation.

The bisphosphonate risedronate (Actonel - Procter & Gamble) was recently approved by the FDA in a 150- mg once-monthly oral tablet for prevention and treatment of postmenopausal osteoporosis. The drug is also available for the same indication in 5-mg daily, 35-mg weekly and 75-mg twice-monthly tablets.

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...

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...

Zoledronic acid (Reclast - Novartis) is the first bisphosphonate approved by the FDA for once-yearly intravenous (IV) treatment of osteoporosis in postmenopausal women. Reclast is also approved for treatment of Paget's disease. Another IV formulation of zoledronic acid (Zometa) is approved for treatment of hypercalcemia of malignancy, multiple myeloma and bone metastases from solid tumors.

Pharmacologic treatment is recommended for postmenopausal women who have bone density T-scores (standard deviations from normal mean values in the spine, femoral neck, total hip, or distal radius) of -2.5 or below, T-scores between -1.0 and -2.5 with a history of fragility (low-trauma) fracture of the hip or spine, or T-scores between -1.0 and -2.5 with a FRAX 10-year probability of ≥3% for hip fracture or ≥20% for major osteoporotic fracture.