TORONTO, June 5 /PRNewswire/ -- Results from a recent Phase III trial evaluating the safety and efficacy of risedronate sodium tablets 35mg for male osteoporosis were presented today at the International Osteoporosis Foundation (IOF) World Congress on Osteoporosis. In the trial, patients treated with risedronate experienced a statistically significant 4.5 percent (p<0.0001) increase in lumbar spine bone mineral density (LS BMD) compared to patients receiving placebo after two years.
"Osteoporosis in men is a widely underrecognized and underdiagnosed condition," said Dr. Steven Boonen, MD, PhD, Professor of Medicine at Leuven University Centre for Metabolic Bone Diseases in Leuven, Belgium. "There is need for greater attention to the disease and for the development of safe, effective therapeutic options. Risedronate, if approved for the treatment of male osteoporosis, would provide a valuable new treatment option for some patients."
In the trial, sponsored by Procter & Gamble Pharmaceuticals and sanofi-aventis U.S. (The Alliance for Better Bone Health), patients treated with risedronate experienced statistically significant improvements in LS BMD at all time points measured, 6, 12, and 24 months. Likewise, statistically significant reductions in bone turnover markers (BTMs) were achieved at all time points measured, 3, 6, 12, and 24 months. Overall, risedronate was well-tolerated, and adverse events were generally similar between patients receiving risedronate and patients receiving placebo. The most commonly reported adverse events were constipation, back pain, arthralgia, influenza, and nasopharyngitis.
About the Study
The double-blind, randomized, placebo-controlled, parallel group, multicenter study included 284 men (95 percent Caucasian) between the ages of 36 and 84 years, inclusive, who had osteoporosis (lumbar spine T-score less than or equal to -2.5 and femoral neck T-score less than or equal to -1 SD, or lumbar spine T-score less than or equal to -1 and femoral neck T-score less than or equal to -2 SD) and not more than one osteoporosis-related fracture. Study participants were randomized (2:1) to either risedronate sodium tablets 35 mg once a week (N=191) or placebo (N=93) and received daily supplements of calcium (1000 mg) and vitamin D (400-500 IU) for two years. The primary endpoint was mean percent change from baseline in lumbar spine BMD relative to placebo. Secondary endpoints included BMD changes at the femoral neck, femoral trochanter, and total proximal femur, as well as percent changes from baseline in BTMs including type I collagen C-telopeptide (CTx), type I collagen N-telopeptide/creatinine (NTx/cr), and bone-specific alkaline phosphatase (BAP).
About Male Osteoporosis
According to the National Osteoporosis Foundation, osteoporosis affects two million men in the U.S. and another 12 million men are at risk for developing the disease. However, osteoporosis in men remains largely underrecognized and underdiagnosed, and is often viewed as a woman's disease. Patients with osteoporosis are at increased risk of fracture. Because it is difficult to see or feel bone loss, many men do not realize that they have osteoporosis until they experience a fracture. In many cases, early prevention and treatment may make a difference.
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe. It is a collaboration between Procter & Gamble Pharmaceuticals and sanofi-aventis U.S.
About Procter & Gamble (NYSE:PG)
Three billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Pampers(R), Tide(R), Ariel(R), Always(R), Whisper(R), Pantene(R), Mach3(R). Bounty(R), Dawn(R), Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R), Iams(R), Crest(R), Oral-B(R), Actonel(R), Duracell(R), Olay(R), Head & Shoulders(R), Wella, Gillette(R), and Braun. The P&G community consists of almost 140,000 employees working in over 80 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.
About sanofi-aventis
Sanofi-aventis is the world's third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE:SNY) .
For P&G: All statements, other than statements of historical fact included in this release, are forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. In addition to the risks and uncertainties noted in this release, there are certain factors that could cause actual results to differ materially from those anticipated by some of the statements made. These include: (1) the ability to achieve business plans, including with respect to lower income consumers and growing existing sales and volume profitably despite high levels of competitive activity, especially with respect to the product categories and geographical markets (including developing markets) in which the company has chosen to focus; (2) successfully executing, managing and integrating key acquisitions (including the Domination and Profit Transfer Agreement with Wella); (3) the ability to manage and maintain key customer relationships; (4) the ability to maintain key manufacturing and supply sources (including sole supplier and plant manufacturing sources); (5) the ability to successfully manage regulatory, tax and legal matters (including product liability matters), and to resolve pending matters within current estimates; (6) the ability to successfully implement, achieve and sustain cost improvement plans in manufacturing and overhead areas, including the success of the company's outsourcing projects; (7) the ability to successfully manage currency (including currency issues in volatile countries), interest rate and certain commodity cost exposures; (8) the ability to manage the continued global political and/or economic uncertainty and disruptions, especially in the company's significant geographical markets, as well as any political and/or economic uncertainty and disruptions due to terrorist activities; (9) the ability to successfully manage increases in the prices of raw materials used to make the company's products; (10) the ability to stay close to consumers in an era of increased media fragmentation; and (11) the ability to stay on the leading edge of innovation. For additional information concerning factors that could cause actual results to materially differ from those projected herein, please refer to our most recent 10-K, 10-Q and 8-K reports.
Source: The Alliance for Better Bone Health
CONTACT: Paula Koenigs of Procter & Gamble Pharmaceuticals,
+1-513-622-3923, koenigs.pm@pg.com; or Terri Pedone of sanofi-aventis,
+1-908-243-6578, terri.pedone@sanofi-aventis.com; or Angela Collom,
+1-215-928-2188, acollom@dorland.com, or Kate Gormley, +1-215-928-2720,
kgormley@dorland.com, both of Dorland Global Public Relations for The Alliance
for Better Bone Health