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that manufacture
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osteoporosis
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• actonel • aredia • boniva • didronel • evista • Forteo • fosamax • miacalcin • zometa • vivelle • reclast •
Boniva is a prescription medicine used to treat or
prevent osteoporosis in women after menopause. Boniva
may reverse bone loss by stopping more loss of bone and
increasing bone mass in most women who take it, even
though they won't be able to see or feel a difference.
Boniva may help lower the chances of fractures
Facts about
Boniva:
Daily Boniva (2.5 mg) was approved for the
treatment and prevention of osteoporosis based on
studies showing that, over three years, it significantly
reduced the risk of new vertebral fractures in women
with postmenopausal osteoporosis and increased bone
mineral density (BMD) in postmenopausal women without
osteoporosis
Once-monthly oral Boniva (150 mg)
was approved based on results from the MOBILE
study (Monthly Oral iBandronate In LadiEs), a
randomized, double-blind, multinational,
non-inferiority trial in 1,602 women with
postmenopausal osteoporosis. MOBILE showed the
following:
- The monthly dose was at least equivalent
to the daily dose in increasing BMD after
one year at the lumbar spine and other
skeletal sites
- The mean increase from baseline in
lumbar spine BMD was 4.9 percent in the
once-monthly group and 3.9 percent in the
daily group (p=0.002)
- The once-monthly group also had
consistently higher BMD increases at the
other skeletal sites compared to the daily
group
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What should I avoid while taking Boniva?
Do not take other medicines, or eat or drink
anything but plain water before you take Boniva and for
at least one hour after you take it.
Do not lie down for at least one hour after you take
Boniva.
What are the possible side effects of Boniva?:
pain or trouble with swallowing
chest pain
very bad heartburn or heartburn that does not get better
diarrhea
pain in extremities (arms or legs)
dyspepsia (upset stomach)
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. |
Once-a-Month
Osteoporosis Drug Approved
Boniva Is First Monthly Pill for Any Chronic Disease
March 28, 2005 - A new osteoporosis drug allows people
to protect their bones by taking just one pill a month.
Today (3/28/05) the FDA approved a once-a-month version
of the osteoporosis drug Boniva. The approval makes the
drug the first once-a-month medicine designed to treat
postmenopausal osteoporosis or any other chronic
disease.
Boniva is part of a class of osteoporosis drugs known as
bisphosphonates, which help build and maintain bone
density (a measure of bone strength) in people with
osteoporosis. Other drugs in
this class include Actonel and Fosamax, but these must
be taken daily or weekly.
Once-monthly Boniva is expected to become available in
U.S. pharmacies in April. Boniva is also available as a
daily osteoporosis drug.
12 Pills a Year
Nearly 50 million Americans over 50 are affected by or
at risk for osteoporosis, mostly postmenopausal women.
Currently, other bisphosphonates are prescribed as daily
or once-a-week pills. Researchers say the new treatment
option may allow some people with osteoporosis to cut
back on the number of pills they take to 12 tablets per
year.
The once-monthly pill should be taken with plain water
in the morning, and users should remain upright and
avoid other foods or drinks for at least 60 minutes.
This is to prevent the pill from
getting stuck in the esophagus and causing damage and
trouble swallowing.
Works as Well as Daily
The FDA approved the once-a-month
version of Boniva based on clinical trials involving
1,602 postmenopausal women with osteoporosis. The
studies showed that the once-monthly osteoporosis drug
was at least as good as the daily dose in increasing
bone density of the spine and lower back after one year
of treatment.
Boniva is not recommended for people who are unable to
stand or sit upright for at least 60 minutes, people
with high calcium levels, or people with sensitivities
to bisphosphonates. The most common side effects of
bisphosphonates include stomach disorders and ulcers.
Roche
Osteoporosis Drug Gets U.S. Approval
Monday, May 19, 2003
ZURICH (Reuters) - Roche Holding AG said on Monday U.S.
regulators had approved its Boniva drug for the
treatment and prevention of osteoporosis in
post-menopausal women, a condition that makes their
bones brittle.
Roche, which is developing the drug with
GlaxoSmithKline, said it was working on an improved
version of the medicine that does not have to be
administered every day -- a factor analysts said made it
uncompetitive in its approved form.
The approval of the once-daily formulation was based
on data showing the bisphosphonate helped reduce the
incidence of new vertebral fractures in women
with postmenopausal osteoporosis.
"Now we will focus on clinical trials of more
innovative, more patient-friendly regimens, which means
less frequent dosing," a Roche spokesman said. Clinical
trials were under way.
He did not say what frequency of dosing the partners
were aiming for given a dramatic switch away from
once-daily treatment in favour of once-a-week therapy.
Boniva used to be called Bonviva, but Roche has now
changed its name. It is also marketed in Europe under
the trade name Bondronat for cancer-related bone
complications.
Analysts questioned whether the drug would ever be
launched in its current dosing.
"This Boniva formulation will hardly be competitive
as current osteoporosis treatment options such as
Merck's Fosamax are administered once weekly, which is
more convenient for patients," Bank Sarasin's Denise
Gugerli wrote in a note.
"Roche told us that it is unlikely that they will
bring the once-daily formulation to the market," she
said, adding Roche was testing the drug when
administered once every three or four weeks.
Roche said some 10 million people in the United
States have osteoporosis and nearly 34 million more have
low bone mass, which boosts their risk of contracting
the disease.
| September 21, 2002 -- Nutley
N.J. |
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STUDY
DEMONSTRATES IBANDRONATE REDUCES
NEW VERTEBRAL FRACTURES WITH BETWEEN-DOSE
INTERVAL
OF GREATER THAN TWO MONTHS |
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| Ibandronate, a potent
bisphosphonate currently under clinical
investigation for the treatment and prevention
of osteoporosis in post-menopausal women, was
shown to reduce new vertebral fractures,
according to data presented here at the 24th
annual meeting of the American Society for Bone
and Mineral Research (ASBMR). Based on findings
from the large, multinational study,1
ibandronate is the first bisphosphonate shown to
reduce new vertebral fractures with a between
dose interval of greater than two months,
holding promise for development of new
convenient, less frequent dosing regimens.
Ibandronate is under joint development by Roche
and GlaxoSmithKline.
Results presented from BONE, a three-year,
pivotal phase III trial in more than 2,900 women
with postmenopausal osteoporosis showed oral 2.5
mg daily ibandronate reduced the risk of new
vertebral fractures by 62 percent compared with
placebo. In addition, study results showed an
intermittent (20 mg) dose of oral ibandronate
taken every other day for 24 days followed by a
between-dose interval of greater than two months
(i.e. 9-10 weeks), reduced the risk of new
vertebral fractures by 50 percent compared with
placebo.1
"These findings are encouraging because they
show that ibandronate reduced the risk of new
vertebral fractures in women with
post-menopausal osteoporosis,"said Robert
Recker, M.D., chief of endocrinology and
director of the Osteoporosis Research Center at
the Creighton University School of Medicine,
Omaha, Nebraska and an investigator in the
study. "Importantly, data from the intermittent
regimen provide a scientific basis for
evaluation of new dosing regimens that require
less frequent dosing. Such regimens may offer
added convenience for patients," he said.
Study and Findings
The presentation reported findings from a
three-year, randomized, double-blind,
placebo-controlled, multinational phase III
pivotal study and expanded on information first
reported at the World Congress on Osteoporosis
earlier this year. In the study, 2,946
post-menopausal women between age 55 and 80
years with osteoporosis were treated with either
placebo or one of two oral ibandronate
schedules: daily (2.5 mg) or intermittent (20
mg) taken every other day for 24 days followed
by a between-dose interval of greater than two
months. All participants received daily oral
calcium (500 mg) and vitamin D (400 IU)
supplementation.
Over the three years of the study, the daily
and intermittent ibandronate regimens
significantly reduced new vertebral fractures by
62 percent and 50 percent, respectively,
compared to placebo. The cumulative incidence of
vertebral fractures in the placebo group was
9.6% over three years, 4.7% in the 2.5mg daily
group and 4.9% in the 20mg intermittent group.
In the study, ibandronate demonstrated a
favorable tolerability profile, with the most
commonly reported adverse events being (percent
of patients taking placebo, ibandronate 2.5 mg
daily, and ibandronate 20 mg intermittent,
respectively): upper respiratory tract infection
(31, 32, 31), back pain (13, 14, 16), arthralgia
(14, 14, 15), dyspepsia (9, 11, 9) and
bronchitis (7, 11, 9). The percentage of
patients who withdrew from the study due to
adverse events was approximately 18 percent in
each of the three groups.
About Ibandronate
Ibandronate has been studied to date in
clinical trials involving more than 9,000
patients. The ongoing clinical development
program is evaluating monthly oral and
intermittent intravenous dosage regimens in
women with post-menopausal osteoporosis.
About Osteoporosis
Osteoporosis is a disease characterized by
low bone mass, increased fragility and a
consequent increase in fracture risk and
disability. It is estimated that one out of
three post-menopausal women aged 50 years and
older is affected by osteoporosis. One in two
women over the age of 50 will have an
osteoporosis-related fracture in their lifetime.
Approximately 80 percent of people with
osteoporosis are women, and 20 percent are men.
About the Roche/GlaxoSmithKline Alliance
In December 2001, Roche and GlaxoSmithKline
announced that they will co-develop and plan to
co-promote ibandronate for the treatment of
postmenopausal
osteoporosis. Roche and GlaxoSmithKline plan
to co-promote ibandronate in all countries,
except Japan. The Roche/GSK alliance provides
expertise and commitment to bring new
osteoporosis therapies to market as quickly as
possible.
About Roche
Hoffmann-La Roche Inc. (Roche), based in
Nutley, N.J., is the U.S. prescription drug unit
of the Roche Group, a leading research-based
health care enterprise that ranks among the
world’s leaders in pharmaceuticals, diagnostics
and vitamins. Roche discovers, develops,
manufactures and markets numerous important
prescription drugs that enhance people's health,
well-being and quality of life. Among the
company’s areas of therapeutic interest are:
dermatology; genitourinary disease; infectious
diseases, including influenza; inflammation,
including arthritis and osteoporosis; metabolic
diseases, including obesity and diabetes;
neurology; oncology; transplantation; vascular
diseases; and virology, including HIV/AIDS and
hepatitis C.
For more information on the Roche
pharmaceuticals business in the United States,
visit the company’s web site at:
http://www.rocheusa.com |
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