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Two FDA advisory committees recently concluded that use of a nasal spray formulation of the peptide hormone salmon calcitonin for treatment of postmenopausal osteoporosis is associated with an increased risk of cancer. Salmon calcitonin is available as 2 nasal sprays (Miacalcin, Fortical) and an injectable formulation (Miacalcin Injection) for use in osteoporosis.1The new cancer concern arose from the results of an unpublished meta-analysis that included 18 studies of Miacalcin Nasal Spray in which the risk of any cancer was 1.54 times greater (95% CI: 1.06, 2.23) in patients who used the...

A new effervescent formulation of alendronate (Binosto – Mission) was recently approved by the FDA for treatment of osteoporosis. The new 70-mg effervescent tablet is considered bioequivalent to the usual 70-mg tablet formulations of alendronate (Fosamax, and generics), which are difficult to swallow and can cause esophageal injury.1 No published studies of the new formulation are available.LABELING — The new strawberry-flavored effervescent tablet should be dissolved over at least 5 minutes in 4 ounces of water (not mineral or flavored water) and stirred for 10 seconds before drinking....

Long-term use of bisphosphonates for prevention and treatment of osteoporosis has been associated with osteonecrosis of the jaw, atypical fractures of the femur, and possibly esophageal cancer. So for how long should patients take them?

The US Preventive Services Task Force (USPSTF) has issued a Draft Recommendation Statement saying, in effect, that community-dwelling women and men should not take calcium and vitamin D supplements for primary prevention of osteoporotic fractures because the evidence that they are helpful is insufficient and they increase the risk of kidney stones. The Medical Letter has said previously that there is no evidence that patients with an adequate intake of calcium (1000-1200 mg/day) and vitamin D (600-800 IU/day) will benefit from taking supplements.11. Drugs for postmenopausal osteoporosis....

Osteoporosis is characterized by low bone mass with microarchitectural disruption and skeletal fragility that results in an increased risk of fracture. The diagnosis has traditionally been established by bone densitometry, which is generally reported in terms of standard deviations (SD) from mean values in young adults (T-score). The World Health Organization (WHO) has defined normal bone mineral density (BMD) for women as a value within one SD of the young adult mean. Values 2.5 SD or more below the mean (T score -2.5) are defined as osteoporosis. The WHO has developed a computerized model...

The FDA has approved Duexis (Horizon), a fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the H2-receptor antagonist (H2RA) famotidine, for symptomatic relief of osteoarthritis and rheumatoid arthritis and to decrease the risk of developing gastric and duodenal ulcers in patients at risk for NSAID-associated ulcers. Vimovo, a combination of the NSAID naproxen and the proton pump inhibitor (PPI) esomeprazole, is also approved by the FDA for prevention of NSAID-associated gastric ulcers.

Supplemental calcium is recommended for prevention of postmenopausal osteoporosis in women with an inadequate dietary intake of calcium. The safety of calcium supplements has recently been questioned; patients may ask if they should continue to take them. The source of this concern was the publication of 2 meta-analyses in the British Medical Journal.

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...

Revised 6/22/11: The last sentence in the Dosage and Cost section about alendronate has been revised.A new enteric-coated delayed-release formulation of risedronate (Atelvia – Warner Chilcott) has been approved by the FDA for treatment of postmenopausal osteoporosis. Unlike immediate-release risedronate (Actonel) and all other oral bisphosphonates, which must be taken after an overnight fast and at least 30 minutes before eating breakfast, the new formulation is taken immediately after breakfast with at least 4 ounces of water. Then the patient must remain upright for at least 30...

The FDA has approved use of denosumab (Prolia – Amgen) for treatment of osteoporosis in postmenopausal women at high risk for fracture.