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First once-monthly therapy approved for treatment and prevention of osteoporosis

Boniva Ibandronate 150-mg tablets
ROCHE/GLAXOSMITHKLINEFirst once-monthly therapy approved for treatment and prevention of osteoporosis
Ibandronate is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. In postmenopausal women, this action reduces the elevated rate of bone turnover and leads to a net gain in bone mass on average. Ibandronate 150 mg was approved on March 24, 2005, for the once-monthly treatment and prevention of osteoporosis in post-menopausal women.

Efficacy. Ibandronate 150 mg once-monthly demonstrated noninferiority to ibandronate 2.5 mg daily in lumbar spine bone mineral density (BMD) in a 1-year double-blind study of women with postmenopausal osteoporosis (N=645). At 1 year, the mean increases in lumbar spine BMD from baseline were 3.86% (95% CI, 3.40%-4.32%) in the 2.5-mg daily group compared with 4.85% (95% CI, 4.41%- 5.29%) in the 150-mg once-monthly group. The mean difference between 2.5 mg daily and 150 mg monthly ibandronate was 0.99% (95% CI, 0.38%-1.60%; P=.002).

Safety. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before initiation of therapy with ibandronate. Patients who are unable to stand or sit upright for at least 60 minutes should not take ibandronate. Orally administered bisphosphonates have been associated with dysphagia, esophagitis, and esophageal or gastric ulcers as well as ocular inflammations such as uveitis and scleritis. Osteonecrosis, primarily in the jaw, has been reported in patients treated with bisphosphonates. Severe and occasionally incapacitating bone, joint, and/or muscle pain has also been reported in patients being treated with bisphosphonates. The most common adverse events associated with ibandronate 150 mg include dyspepsia, nausea, diarrhea, constipation, abdominal pain, arthralgia, back pain, and pain in extremity.

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