New study shows women with osteoporosis preferred once-monthly dosing of Boniva over a once-weekly medicine
Women cite ease of compliance as key reason for preferring the once-monthly dosing of Boniva
Nutley, N.J. and Research Triangle Park, N.C. (March 17, 2006) – Roche and GlaxoSmithKline (GSK) today announced results of an international study that demonstrates more than two-thirds (70%) of women with postmenopausal osteoporosis, who expressed a preference, preferred once-monthly dosing with Boniva® (ibandronate sodium) over weekly dosing with Fosamax® (alendronate sodium).  The study, called BALTO II (BonivaALendronate Trial in Osteoporosis), is being presented for the first time at the Sixth European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO). The majority of patients found once-monthly dosing of Boniva to be more convenient than weekly dosing of Fosamax.
In the study, the most common reason women gave for their preference was that one tablet a month is an easier treatment regimen to follow for a long period of time. Faced with no immediate symptoms from osteoporosis, half to almost two-thirds of women quit their daily or weekly osteoporosis medication within one year. Once-monthly Boniva , a bisphosphonate was approved by the FDA in March 2005. Bisphosphonates are the most frequently prescribed class of medication for the treatment and prevention of postmenopausal osteoporosis.
“Rigorous clinical studies have demonstrated that Bonivabuilds and maintains bone density and reduces the risk of fracture,” said Ronald Emkey, M.D., Director, Metabolic Bone Disease, Arthritis and Osteoporosis Clinic, Reading, PA and lead investigator of the U.S.-based BALTO I study presented at the biggest bone and mineral research meeting in the U.S.last year. “This new study confirms that women view the once-monthly dosing of Boniva to be convenient and easier to follow over the long term. This is important because fracture protection can only be achieved if women stay on therapy.”
About BALTO II
BALTO II is a six-month, prospective, randomized, open-label crossover trial that included 350 women with postmenopausal osteoporosis who took both once-monthly oral Boniva (150 mg) and once-weekly oral alendronate (70 mg) each for three consecutive months during the study. As is standard practice, physicians involved in the study were aware of existing clinical data for both study medications and were therefore able to ensure all patients enrolled were suitable for either medicine. By the end of the trial, the majority of women reporting a preference (n = 299) chose the once monthly Boniva regimen (70.6%). A total of 6.9% of patients did not have a preference for either treatment regimen. Of those reporting on convenience, 76.6% found the monthly Boniva dose more convenient than weekly alendronate. 11.7% found both treatments equally convenient. The efficacy of the regimens was not assessed in the study.
Boniva Fracture Efficacy
In a 3-year clinical study, oral Boniva (2.5 mg daily) decreased the relative risk of new vertebral fractures by 52 percent at year three compared to placebo. Oral Boniva (2.5 mg daily) also has demonstrated significant increases in bone mineral density (BMD) – a proven surrogate marker for fracture protection – starting as early as six months and progressing through three years at both the vertebral and nonvertebral (total hip, femoral neck, trochanter) sites. In a separate two-year study, once-monthly Boniva (150 mg) demonstrated consistently higher BMD increases at all measured skeletal sites, as compared to Boniva 2.5 mg daily after both one and two years of therapy.
Osteoporosis (porous bones) is a disease in which bones become brittle and more likely to break. 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 (osteopenia), placing them at increased risk for osteoporosis. Unfortunately, the prevalence of osteoporosis is growing, especially as the number of postmenopausal women in the population continues to rise. Together, osteoporosis and osteopenia are expected to affect an estimated 52 million women and men age 50 and older by 2010, and 61 million by 2020.4 Direct medical costs of osteoporosis total nearly $18 billion in the U.S.each year.
Osteoporosis treatment does not work if patients do not stay on therapy (poor persistence), which is a serious problem since approximately half to almost two-thirds of patients quit taking their osteoporosis medication within a year.2
About Once-Monthly Oral Boniva
Once-monthly Boniva is a small, film-coated, easy-to-swallow tablet dosed at 150 mg. Patients should take Boniva with plain water on an empty stomach upon rising in the morning. They should remain upright and avoid food, drink and other medications for at least 60 minutes.
Patients who take Boniva are eligible to sign up for MyBONIVA, a program designed to help enhance compliance (taking therapy as directed) and persistence with this unique once-monthly regimen. For more information on this program call 1-800-4BONIVA or visit www.myboniva.com.
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. Bonivais 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 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 , see contact information at the end of the news release or go to www.boniva.com.
Roche and GSK Collaboration
F. Hoffmann-La Roche (Roche) and GlaxoSmithKline (GSK) co-promote Bonivafor the treatment and prevention of postmenopausal osteoporosis in all countries except Japan. The Roche and GSK collaboration provides expertise and commitment to bringing new osteoporosis therapies to market as quickly as possible.
Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. For further information, visit www.rocheusa.com.
GSK, one of the world’s leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GSK on the World Wide Web at www.gsk.com.
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Fosamax is a registered trademark of Merck & Co., Inc.
 BALTO II Clinical Study Report, MA17844(RR1020118)
 Data on file from an October 2002-2003 study of prescription data of women with osteoporosis. (Ref. 161-011), Hoffmann-La Roche Inc., Nutley, NJ.
 Stafford RS, Drieling RL, Hersh AL. National trends in osteoporosis visits and osteoporosis treatment, 1988-2003. Arch Intern Med. Jul 26 2004;164(14):1525-1530.
4 America’s Bone Health: The State of Osteoporosisand Low Bone Mass in Our Nation: The National Osteoporosis Foundation; February 2002.
 Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD: U.S.Department of Health and Human Services, Office of the Surgeon General; 2004.
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