Study of Over 33,000 Women Comparing Two Most Prescribed Osteoporosis Treatments Shows Significant Difference in Hip Fra

PARIS, November 17 /PRNewswire/ --

-- Actonel Almost Halves the Risk of Breaking a Hip When Compared to Alendronate in the First Year of Treatment

-- For Non-US Journalists Only

Data published today from a retrospective study of over 33,000 postmenopausal women showed that among patients newly prescribed one of the two most popular osteoporosis treatments, patients taking Actonel(R) (risedronate sodium) were approximately half as likely to sustain a hip fracture as those taking alendronate in the first year of treatment. These results were published today in the peer-reviewed journal Osteoporosis International.(1)

"The rapid onset of fracture reduction observed for risedronate in this study is consistent with results from randomised clinical trials of risedronate," says Professor Pierre Delmas, study author, Université Claude Bernard, Lyon. "Earlier fracture protection means that fewer patients will suffer the devastating consequences of an osteoporotic fracture, helping to both preserve patients' quality of life and to reduce the economic burden of healthcare."

The REAL (RisedronatE, ALendronate) retrospective cohort study included 33,830 women newly treated with once-weekly doses of either Actonel or alendronate in 'real-life' clinical practice. Results showed that at six months patients on Actonel had a 46% (p=0.02) lower incidence of hip fractures compared to patients on alendronate. At 12 months similar results were seen, with Actonel resulting in a 43% (p=0.01) greater reduction in risk of hip fracture versus alendronate. The two treatments were not compared on the basis of side effects in this study.

This study adds to the body of evidence from randomised controlled trials demonstrating that Actonel exerts an early onset of fracture protection, seen as early as six months for clinical vertebral fracture and non-vertebral fractures.(2-3) No other bisphosphonate treatments for osteoporosis have been shown in clinical trials to reduce clinical fractures this early for patients. However, data are limited that compare therapies directly in the same study on the basis of fracture reduction - the clinically important endpoint in osteoporosis treatment.

"In the osteoporosis field it is unlikely that prospective, head-to-head clinical fracture trials will be conducted due to the large number of patients required to show a difference between two effective therapies," said Professor Delmas. "Large, comparative, retrospective analyses, like the REAL study, are one way to fill the knowledge gap and should be considered in the total body of evidence for a drug to optimise treatment decisions and enhance patient care."

Currently 1.6 million hip fractures occur worldwide per year,(4) accounting for approximately EUR104 billion in worldwide annual healthcare costs.(5) Among those patients who suffer a hip fracture, approximately one in five will die within the following year,(6,7) and 40% will be unable to walk independently one year later.(8)

Notes to Editors:

About the REAL study

The RisedronatE, ALendronate (REAL) cohort study was a retrospective analysis of a health service utilisation database. These databases are generated by medical insurers for the payment or reimbursement of health services. They include longitudinal, patient specific information such as diagnosis codes for reimbursable expenses (e.g. fractures) and pharmacy dispensations. The REAL study utilised a US database of 12 million insured participants. It was a pooled dataset of one health plan within Ingenix Lab/Rx, and the 100 employer health plans within Medstat Marketscan.

From the dataset, women aged 65 years and older were identified who were new users of weekly bisphosphonate therapy, either risedronate 35 mg (N=12,215) or alendronate 35 mg or 70 mg (N=21,615). Patients had to have at least six months medical history prior to treatment initiation and were followed for 12 months after bisphosphonate initiation to assess 6 and 12 month fracture incidence at both the hip and at a composite group of non-vertebral sites (hip, wrist, clavicle, humerus, pelvis and leg). Standard statistical methods were used to compare the incidence of fracture between the risedronate and alendronate groups (Cox proportional hazard modelling). As with all retrospective cohort studies, an important concern is that in real world clinical practice patients are not randomly assigned to treatment groups, potentially introducing "selection bias" into the results. The risedronate and alendronate groups were compared for risk factors for fracture at baseline, and all results were risk-adjusted for potential differences in baseline fracture risk.

In the study, patients on Actonel had 46% (p=0.02) and 43% (p=0.01) lower incidence of hip fracture than patients taking alendronate at 6 and 12 months, respectively. Prior to risk adjustment for baseline differences in fracture risk, the crude incidence of fracture in each population was as follows: At six months, 0.29% of alendronate patients had sustained a hip fracture, compared to 0.17% of Actonel patients. At 12 months, 0.58% of alendronate patients had suffered a hip fracture, compared to 0.37% of Actonel patients.

With respect to non-vertebral fracture, patients on risedronate had 19% (p=0.05) and 18% (p=0.03) lower incidence of non-vertebral fracture than patients on alendronate at 6 and 12 months, respectively. Prior to risk adjustment for baseline differences in fracture risk, the crude incidence of fracture in each population was as follows: At six months, 1.31% of alendronate patients had experienced non-vertebral fracture, compared to 1.14% of Actonel patients. At 12 months, 2.30% of alendronate patients had sustained non-vertebral fracture, compared to 1.99% of Actonel patients.

Please see the full prescribing information for each treatment to obtain more information on the adverse events associated with each therapy.

All study investigators had full access to the complete dataset, and each of them independently verified the results of the analyses at their respective institutions. The study was sponsored by The Alliance for Better Bone Health.

About osteoporosis

Osteoporosis is a skeletal disease that increases bone fragility and susceptibility to fracture. Fracture is a devastating consequence of osteoporosis and can occur at any site of the body. A 50-year-old woman has around a 40% lifetime risk of suffering a fracture from osteoporosis(9) - equivalent to the women's lifetime risk for cardiovascular disease.(10)

About The Alliance for Better Bone Health

The Alliance for Better Bone Health was formed by Procter & Gamble Pharmaceuticals and Aventis part of the sanofi-aventis Group, in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe.

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 over 135,000 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.

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