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.
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
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
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.