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Young People Get Osteoporosis Too 

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DISCLAIMER:

Please be advised that the inclusion of any medication on this site is not indicative of an endorsement.  I do not have any affiliation with the pharmaceutical corporations that manufacture prescription osteoporosis medications.  I am not a doctor, therefore I am not medically qualified to counsel or advise osteoporosis patients about which medication is best suited for their individual case.

• 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

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.
 

STUDY DEMONSTRATES IBANDRONATE REDUCES
NEW VERTEBRAL FRACTURES WITH BETWEEN-DOSE INTERVAL
OF GREATER THAN TWO MONTHS

 
 
 
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