Untreated Postmenopausal Women With Osteoporosis At Risk For First Spinal Fracture Within One Year

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AACE: Untreated Postmenopausal Women With Osteoporosis At Risk For First

Spinal Fracture Within One Year

BOSTON, MA -- April 28, 2004 -- Results of a new analysis found that,

without

treatment, one out of 13 postmenopausal osteoporotic women who were

initially

fracture-free were likely to experience a spinal fracture within one year.

This risk of fracture was present despite these patients taking supplemental

calcium, and if necessary, Vitamin D. Data were presented today at the

annual

meeting of the American Association of Clinical Endocrinologists (AACE).

Additionally, a statistical model was presented that predicted the

progression over time of subsequent spinal fractures in a population of

osteoporotic

women who were initially fracture-free. The model was based upon data from

the

placebo arms of Phase III fracture trials for Actonel® (risedronate sodium

tablets), and it included data for 2,326 patients whose fracture status

(i.e.

number of spinal fractures) was assessed at baseline and at yearly

intervals. The

model showed that the prevalence of spinal fractures rapidly increased over

time if the population of osteoporotic women was not treated, and projected

that therapy which reduced the risk of a first fracture within one year

could

substantially reduce the risk of future fracture.

" We previously established in another analysis that a postmenopausal

osteoporotic woman who has already suffered a spinal fracture has a one in

five risk

of having another spinal fracture within one year; therefore, intervening

before that first fracture occurs is important, " said Dr. ,

Chief of

Internal Medicine at Helen Hospital, West Haverstraw, NY and principal

investigator on this study. " With one in 13 osteoporotic women at risk of

that

first spinal fracture within the year, choosing a therapy proven to act

rapidly is important. "

About the Analysis

Data for the analysis were from patients in the placebo arms of the Actonel

fracture trials (VERT-MN, VERT-NA, HIP). The women had lumbar spine or

femoral

neck bone mineral density T-scores of less than -2.5 or had one or more

prevalent spinal fractures. All patients received 1,000 mg daily calcium

and, if

baseline levels were low, up to 500 IU Vitamin D daily.

The data were used to estimate the probabilities of having zero, one, or

multiple spinal fractures within one year for patients having any number

(0-13) of

prevalent spinal fractures. Using these one-year risk estimates, a simple

Markov model was constructed to model the progression of spinal fractures

over

time in a population of untreated osteoporotic women who were initially

fracture-free.

About Osteoporosis

Osteoporosis is a disease characterized by reduced bone strength

predisposing

a person to an increased risk of fracture. According to the National

Osteoporosis Foundation (NOF), 8 million women in the U.S. have

osteoporosis, and 1.2

million osteoporotic fractures occur annually. The NOF estimates that every

20

seconds an osteoporosis-related fracture occurs. Risk factors for

osteoporosis in postmenopausal women include age, personal history or family

history of

fracture, low bone mineral density, cigarette use, and race.

Studies show that among postmenopausal women with osteoporosis who

experience

a spinal fracture, one out of five will suffer their next spinal fracture

within just one year, potentially leading to a fracture cascade. Fractures

can

progress quickly if osteoporosis is left untreated. The NOF, National

Institutes

of Health, and American Association of Clinical Endocrinologists agree that

fracture risk reduction is the efficacy endpoint by which osteoporosis

therapies should be evaluated.

Preventive measures, such as not smoking, maintaining a balanced diet

supplemented with calcium and vitamin D, if needed, and engaging in weight-

bearing

exercise, like walking, can reduce an individual's chances of developing

osteoporosis. However, in some women, these preventive measures may not be

enough,

and prescription medications such as Actonel may be beneficial.

About Actonel® (risedronate sodium tablets)

Actonel is developed by Procter & Gamble Pharmaceuticals and co-marketed by

Procter & Gamble Pharmaceuticals and Aventis. Actonel 35 mg Once-a-Week and

Actonel 5 mg daily are indicated for the prevention and treatment of

osteoporosis

in postmenopausal women. Actonel 5 mg daily is also indicated for the

prevention and treatment of glucocorticoid-induced osteoporosis (GIO) in men

and

women either initiating or continuing systemic glucocorticoid treatment (>

or =

7.5 mg/d prednisone or equivalent) for chronic diseases.

In clinical trials, Actonel was generally well tolerated. Actonel is

contraindicated in patients with hypocalcemia, known hypersensitivity to any

component

of this product, or inability to stand or sit upright for at least 30

minutes. Hypocalcemia and other disturbances of bone and mineral metabolism

should be

effectively treated before starting Actonel therapy. Actonel is not

recommended for use in patients with severe renal impairment (creatinine

clearance < 30

mL/min).

Bisphosphonates may cause upper gastrointestinal disorders such as

dysphagia,

esophagitis and esophageal or gastric ulcer. Patients should pay particular

attention to the dosing instructions, as failure to take the drug according

to

instructions may compromise clinical benefits and may increase the risk of

adverse events.

In clinical trials, the overall incidence of adverse events with Actonel 5

mg

daily was comparable to placebo. The most commonly reported adverse events

regardless of causality were infection (primarily upper respiratory, placebo

29.7 percent vs. Actonel 5 mg 29.9 percent), back pain (23.6 percent vs.

26.1

percent), and arthralgia (21.1 percent vs. 23.7 percent).

In a one-year clinical trial comparing Actonel 35 mg Once-a-Week and Actonel

5 mg daily, the overall incidence of adverse events with the two dosing

regimens was similar. The most commonly reported adverse events regardless

of

causality were infection (Actonel 35 mg 20.6 percent vs. Actonel 5 mg 19.0

percent),

arthralgia (14.2 percent vs. 11.5 percent) and constipation (12.2 percent

vs.

12.5 percent). Please visit http://www.actonel.com for full prescribing

information for Actonel.

SOURCE: The Alliance for Better Bone Health

http://www.docguide.com/news/content.nsf/news/8525697700573E1885256E84004A38

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