Alendronate gives sustained effects in osteoporosis
At the end of a 10-year study into the effects of alendronate (Fosamax) in osteoporosis, researchers have found that the drug provides sustained improvements in bone density and is well tolerated. Discontinuation of alendronate resulted in a gradual loss of its effects.
Almost 250 postmenopausal women with osteoporosis participated in the
extended multicentre, randomised study. Investigators measured bone mineral
density (BMD) at critical skeletal sites prone to osteoporotic fracture.
Treatment with 10mg alendronate daily for 10 years produced mean increases
in BMD of 13.7 per cent at the lumbar spine, 10.3 per cent at the hip
trochanter, 5.4 per cent at the femoral neck and 6.7 per cent in the
total hip compared with baseline. Smaller gains occurred in a group given
5mg daily.
The researchers report that safety profiles were similar during years
8 to 10 for three groups under investigation: one had discontinued active
therapy, another was taking 5mg alendronate and the third was on 10mg
of the drug. The incidence of upper gastrointestinal adverse events was
similar among these groups.
Although the differences were not statistically significant, the fewest
vertebral fractures, least height loss and lowest rate of non-vertebral
fractures occurred in the 10mg alendronate group. Fracture incidence
was used as a safety measure rather than as an efficacy measure, they
note.
The discontinuation of alendronate resulted in a gradual loss of effect,
as measured by bone density and biochemical markers of bone remodelling.
Reporting their results in The New England Journal of Medicine (2004;350:1189),
the authors warn that their findings should not be assumed to apply to
other osteoporosis treatments because each agent may have unique characteristics. |
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