Tuesday, October 04, 2005

Study Shows Women Prefer Once-Monthly Osteoporosis Medicine Over a Once-Weekly

A new study shows the majority of women with postmenopausal osteoporosis prefer a once-monthly dosing regimen compared to a once-weekly.

“In my practice, active women look for an osteoporosis medication that disrupts their routine less often – one that fits their busy lifestyle,” said Ronald Emkey, M.D., lead investigator of the study and medical director of Radiant Research in Reading, Pa. “This makes a once-monthly regimen an important dosing option.”

The study was presented at the 27th Annual Meeting of the American Society for Bone and Mineral Research and included 342 women with postmenopausal osteoporosis who took once-monthly oral Boniva® (ibandronate sodium) and once-weekly oral alendronate (70 mg) each for three consecutive months. The efficacy of the two treatments was not assessed in the study.

In March, the U.S. Food and Drug Administration approved Boniva 150 mg as the first and only once-a-month prescription treatment for postmenopausal osteoporosis. Boniva is co-promoted by Roche and GlaxoSmithKline.

Osteoporosis and low bone mass (osteopenia) are becoming more prevalent in the U.S. today, as the number of postmenopausal women continues to rise. In the U.S. today, 10 million individuals, eight million of whom are women, are estimated to already have osteoporosis, and almost 34 million more are estimated to have low bone mass, placing them at increased risk for the disease. By 2010, osteoporosis and low bone mass are expected to affect an estimated 52 million Americans age 50 and older.

Osteoporosis treatments won’t work if patients don’t stay on therapy – a serious problem since more than half of patients stop taking their medication within a year.

Patients who take Boniva are eligible to sign up for MyBONIVA, a support program designed to help patients maintain the unique monthly regimen.

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Important Safety Information

Boniva is contraindicated in patients unable to stand or sit upright for at least 60 minutes, with uncorrected hypocalcemia, or with known hypersensitivity to any component of Boniva. Boniva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcer. Boniva is not recommended in patients with severe renal impairment. Adequate intake of calcium and vitamin D is important in all patients.

Rarely, patients have reported severe bone, joint and/or muscle pain after taking bisphosphonate therapy for osteoporosis. Additionally, osteonecrosis of the jaw has rarely been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures.

The most commonly reported adverse events with once-monthly Boniva regardless of causality were abdominal pain (Boniva 150 mg 7.8 percent vs. Boniva 2.5 mg 5.3 percent), hypertension (6.3 percent vs. 7.3 percent), dyspepsia (5.6 percent vs. 7.1 percent), arthralgia (5.6 percent vs. 3.5 percent), nausea (5.1 percent vs. 4.8 percent) and diarrhea (5.1 percent vs. 4.1 percent).

For complete prescribing information for Boniva, go to www.boniva.com.

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