Fosamax Drug Aids Bones, Study Finds

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March 18, 2004 Los Angeles Times

Drug Aids Bones, Study Finds

Fosamax, which has become a popular alternative to hormone supplements,

helped osteoporosis sufferers avoid fractures.

From Associated Press

BOSTON — The osteoporosis drug Fosamax keeps strengthening bones, easing

fears that the medicine might eventually boomerang and start making hips

and spines brittle and prone to break, researchers said in a study

released today.

The study is the longest test yet of Fosamax, which was approved in

1995. It has gained quickly in popularity as an alternative to hormone

supplements, which have been linked in recent years to heart disease and

cancer.

" This is a chronic condition and requires long-term treatment, so it's

really important to have the data, " said Dr. Henry Bone, the study's

lead author at St. Medical Center in Detroit.

The results of the research, which was backed by the drug's maker, Merck

& Co. of Whitehouse Station, N.J., and collected by an international

research team, were published today in The New England Journal of

Medicine. The group, which included several researchers who disclosed

that they had ties to Merck, had reported previously on the first

several years of findings in the 10-year experiment. Reporting on the

last five years, the researchers focused on 247 middle-aged and elderly

women with postmenopausal osteoporosis.

The findings are likely to reassure doctors as well as patients who take

Fosamax, known generically as alendronate.

About 8 million American women and 2 million men have osteoporosis.

About 34 million others are at elevated risk. The disease is blamed for

about 1.5 million broken bones a year, including many debilitating

fractures of the hip and back.

The drug, which raked in $2.7 billion in worldwide sales last year,

works by readjusting the continuous process of bone renewal. It slows

bone-destroying cells and thus gives more time for bone-building cells

to catch up. Doctors have wondered, though, whether the slower turnover

might eventually do harm. Will bone finally begin to break as older,

more calcified tissue becomes more predominant?

In this study, that did not appear to happen.

The number of fractures in the final five years was too small to be

considered statistical proof. However, the raw numbers were seen as

encouraging. Among women who took 10 milligrams of Fosamax daily, 5%

suffered back fractures. Among women who stopped taking the drug during

the last five years of testing, 6.6% had such breaks.

" The name of the game in osteoporosis treatment is fracture protection.

That's why this study is so interesting, " said Dr. , a bone

specialist at UC San Francisco.

Bone density measurements were also heartening. The 10-milligram group

gained almost 14% in bone density in the lower spines over a decade,

including nearly 4% over the last five years. The group that stopped

taking the drug boosted its bone density in the lower back by 9% over 10

years — but nearly all of that took place during the first five years.

In the first group, hip bone also became denser, by almost 1%, over the

last five years. The comparison group lost almost 2%.

Osteoporosis chiefly strikes women after menopause. Almost one in two

women over 50 is expected to break a bone as a result of osteoporosis.