[MRK] ACR MEETING: Fosamax Increased Bone Mass In Men Taking Chronic Glucocorticoids
SAN DIEGO, CA -- Nov. 10, 1998 -- New data presented today at the annual
meeting of the American College of Rheumatology showed the investigational use
of Fosamax® (alendronate sodium) in men stopped bone loss and increased
bone mineral density (BMD) at the spine and hip, two common sites of
osteoporotic fracture. The men in the study all were at risk of osteoporosis and
future fracture due to chronic use of glucocorticoids (commonly referred to as
corticosteroids, or steroids).
"Previous studies have shown Fosamax to be effective in treating and preventing
osteoporosis in postmenopausal women," said Barry Gruber, M.D., director of
the Osteoporosis Center and division head of rheumatology at the State
University of New York (SUNY), Stonybrook. "These new data are important
because they looked at the effectiveness and safety of Fosamax in treating and
preventing bone loss in men, as well as women, who are on long-term
glucocorticoid therapy."
Although osteoporosis is commonly thought of as a disease of postmenopausal
women, 20 percent of those who have osteoporosis are men -- many due to
glucocorticoid use. Yet currently there are no medications approved by the U.S.
Food and Drug Administration (FDA) to prevent or treat osteoporosis in men.
Bone loss leading to osteoporosis is one of the most debilitating effects of
long-term treatment with prednisone and other glucocorticoids in the men and
women who take these drugs for chronic conditions such as rheumatologic and
pulmonary diseases. More than 1 million Americans are estimated to use
glucocorticoids to manage conditions including asthma, chronic lung disease,
rheumatoid arthritis, connective tissue disease, inflammatory bowel disease and
organ transplantation.
Early intervention to prevent bone loss is critical because glucocorticoid users
can lose large amounts of bone rapidly -- as much as 20 percent in the first year
of treatment alone. Bone loss from long-term glucocorticoid therapy ultimately
leads to osteoporosis and resulting fractures in an estimated 30 percent to 50
percent of patients.
The results reported by Dr. Gruber came from an analysis of data from a
sub-population of 141 men aged 22 to 79 years from two double-blind 48-week
studies of 477 men and women receiving at least 7.5 mg of steroids (prednisone
or equivalent) daily. Patients in the two studies were randomized to placebo,
Fosamax 5 mg once-daily, or Fosamax 10 mg once-daily. All 477 patients were
supplemented with recommended daily levels of calcium and vitamin D.
At the end of 48 weeks, use of Fosamax (5 mg and 10 mg) prevented bone loss
at the spine and hip. Men on placebo lost bone relative to baseline at these sites.
The statistically significant mean changes in BMD at these sites relative to
baseline were:
-- Lumbar spine: a 3.4 percent and 2.9 percent increase for Fosamax 5 mg and
10 mg, respectively.
-- Femoral neck: a 2.2 percent increase for Fosamax 10 mg versus a 1.6
percent decrease for placebo.
-- Trochanter: a 2.7 percent increase for Fosamax 10 mg versus a 1.3 percent
decrease for placebo.
"The results of this investigational study showed that use of Fosamax was well
tolerated and may be of benefit in protecting against the debilitating bone loss
that is a common side effect of glucocorticoid therapy," reported Dr. Gruber.
"Moreover, as witnessed by the bone loss in the placebo group, calcium and
vitamin D supplementation alone were not sufficient to prevent such bone loss."
Other Data Analyses Showed Consistency of Effect with Fosamax
Other data analyses also released at the American College of Rheumatology
meeting this week from the two studies of 477 men and women using
glucocorticoids found that:
-- Use of Fosamax in patients on chronic glucocorticoid therapy resulted in
consistent gains in spinal BMD regardless of other concomitant medication and
underlying disease state requiring glucocorticoid therapy.
-- BMD increases at the hip and spine in men and women who were
administered Fosamax for glucocorticoid-induced osteoporosis were consistent
with bone mass increases observed at one year in the vertebral fracture arm of
the Fracture Intervention Trial (FIT). In FIT, 2,027 postmenopausal women with
osteoporosis and a prior vertebral fracture were administered Fosamax (5 mg
once-daily) for the first two years of the study followed by Fosamax (10 mg
once-daily) for the third year of the study. |
