Fosamax Approved In Canada For Steroid-Induced Osteoporosis
SAN FRANCISCO, CA -- Dec. 4, 1998 -- The Health Protection Branch of
Health Canada has approved Merck Frosst's Fosamax(R) (alendronate sodium)
for the treatment and the prevention of steroid-induced osteoporosis in men and
women.
This new indication coincides with the presentation of the results of a two-year
study on the effect of Fosamax on glucocorticoid induced osteoporosis, also
known as steroid-induced osteoporosis, at the annual meeting of the American
Society for Bone and Mineral Research.
The study, co-authored by Canadian researchers, confirms that the use of
Fosamax (5 mg or 10 mg) significantly increases bone mass in the hip and spine
and reduces vertebral fractures in both male and female patients on steroid
therapy.
Steroids, such as prednisone, are commonly used in the treatment of
inflammatory diseases such as asthma or rheumatoid arthritis. Although effective
to relieve inflammation, steroids are also known to cause osteoporosis. More
than 120,000 Canadians are estimated to receive daily doses of steroids which
put them at risk of developing osteoporosis. In fact, approximately 60,000
Canadians have developed osteoporosis because of steroid treatment. It is
believed that as many as half of them or 30,000 patients have already suffered at
least one vertebral fracture.
"While steroids play an important role in improving the quality of life of patients
over the short term, the long term impact on bone mass has always been a cause
of concern," said Dr. Jacques Brown, division head of rheumatology, Centre
hospitalier universitaire de Québec, Laval University, and a lead investigator of
the study. "With alendronate, we now know that we can prevent loss and even
rebuild bone mass in both men and women who have developed or are at risk of
developing osteoporosis following a steroid treatment.''
Key findings of the two-year study include:
-- 2.8 percent to 3.8 percent bone mass increase at the spine from baseline
-- 2.2 percent to 3.9 percent bone mass increase at trochanter from baseline
-- 89.8 percent risk reduction in vertebral fractures.
Patients who received a placebo instead of alendronate went on to lose bone
mass.
A total of 208 participants using at least 7.5 mg per day of glucocorticoids, were
randomised to receive either a 5 mg or 10 mg dose of alendronate or an oral
placebo every day. They also received recommended intakes of calcium and
Vitamin D.
The results seen with Fosamax were consistent regardless of age, gender, steroid
dose or the disease that warranted the need for steroid treatment in the first
place.
Bone is a living tissue. In healthy individuals, a delicate balance struck between
bone formation and bone resorption ensures that bones remain strong and are
not prone to fractures.
The chronic use of glucocorticoids or steroids eventually causes a modification of
the bone remodelling process as it leads to a decrease in bone formation as well
as an increase in bone resorption. The combination of these two effects can
translate to an annual rate of bone loss as high as 15 percent.
While women are generally more susceptible to develop osteoporosis,
glucocorticoid-induced osteoporosis equally affects men and women.
"Alendronate offers a well-tolerated and efficacious option for the prevention and
the treatment of glucocorticoid-induced osteoporosis," said Dr. David Hanley,
head, division of endocrinology and metabolism at the University of Calgary and
the Foothills Hospital. "Until such time we can have access to anti-inflammatories
which do not spark the onset of osteoporosis, Fosamax will play an important
role in the preservation of the bone mass of patients who require a steroid
therapy.''
Fosamax was first approved in December 1995. It still remains the only member
of a new class of osteoporosis treatments called aminobisphosphonates. |
