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About Boniva

Boniva is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, Boniva increases bone mineral density and reduces the incidence of vertebral fractures. Boniva also may be considered for postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and reduce the risk of vertebral fracture.Boniva is contraindicated in patients unable to stand or sit upright for at least 60 minutes, patients with hypersensitivity to any component of this product, and patients with uncorrected hypocalcemia. Boniva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer.

BONIVA (ibandronate sodium) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment and prevention of osteoporosis in postmenopausal women.
The approval was based on data showing Boniva, a new bisphosphonate, provided a 52 percent relative reduction in the incidence of new vertebral fractures in women with postmenopausal osteoporosis as well as a favorable tolerability profile. The approval of a once-daily formulation of Boniva marks the end of the initial milestone in developing this medicine. Roche and GSK will continue to study more convenient dosing regimens of Boniva in ongoing clinical trials.
Pivotal study
FDA's approval for the treatment of postmenopausal osteoporosis was based on a pivotal Phase III trial (Study 4411). The study showed that Boniva 2.5 mg once daily reduced the relative risk of new vertebral fractures by 52 percent compared to placebo over the course of three years (4.7 percent vs. 9.6 percent of patients in the Boniva vs. placebo group, respectively, experienced new vertebral fractures during the three years of the study, for an absolute reduction of 4.9 percent or a relative reduction of 52 percent). Treatment with 2.5 mg daily Boniva also resulted in decreases in markers of bone turnover to levels similar to those in premenopausal women.

Study 4411 was a randomized, double-blind, placebo-controlled, multinational study that included postmenopausal women, ages 55 to 80 years who were at least five years postmenopausal, and previously diagnosed with osteoporosis (by presence of at least one vertebral fracture on x-ray and a bone mineral density at least two standard deviations below the average for premenopausal women [T-score] in at least one vertebra [L1-L4]). Patients were randomized to receive either placebo (n=975) or 2.5 mg once daily Boniva (n=977) for three years. All participants received daily oral calcium (500 mg) and vitamin D (400 IU) supplementation. The primary efficacy endpoint was the occurrence of new radiographically diagnosed vertebral fractures after three years of treatment.

Oral Boniva has been studied in over 3900 postmenopausal osteoporosis patients in trials of up to three years. The overall adverse event profile of Boniva 2.5 mg once daily in these studies was similar to that of placebo. Data combined from Study 4411 and Study 4499, a Phase III trial of the 2.5 mg once daily regimen for the prevention of postmenopausal osteoporosis, demonstrated a favorable tolerability profile for Boniva, with the most commonly reported adverse events greater than five percent being (percent of patients taking placebo or Boniva 2.5 mg daily): back pain (12.2, 13.5), pain in extremities (6.4, 7.8), dyspepsia (9.8, 11.9), diarrhea (5.0, 6.8), myalgia (5.1, 5.7), headache (5.8, 6.5), bronchitis (6.8, 10), pneumonia (4.3, 5.9), upper respiratory tract infection (33.2, 33.7) and urinary tract infection (4.2, 5.5). Approximately 17 percent of patients in both the Boniva and placebo groups withdrew from the studies due to adverse events.

About Osteoporosis

Osteoporosis is a major public health threat for an estimated 44 million Americans. In the U.S. today, ten 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. One in two women over age 50 will have an osteoporosis-related fracture in their lifetime. Osteoporosis is responsible for more than 1.5 million fractures annually. The need for therapies to prevent and treat osteoporosis will continue to increase, especially as the number of postmenopausal women in the population continues to rise.

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