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Endocrinology - Hellerman |
Teriparatide |
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March 1 2003 • Volume 36 • Number 5
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Clinical Rounds |
Postmenopausal women
Teriparatide Cuts Spinal Fracture Risk at All Ages
Norra MacReady
Los Angeles Bureau
Teriparatide increases vertebral density and decreases the risk of spinal
fractures in postmenopausal women regardless of their age, fracture history, or
bone mineral density at baseline, reported Dr. Robert Marcus and his associates
at Eli Lilly & Co., Indianapolis.
In a study funded by Lilly, which markets teriparatide as Forteo, the authors
observed a dose-dependent increase in vertebral bone mineral density (BMD) after
3 months of treatment with teriparatide, compared with placebo. There also was a
corresponding reduction in the incidence of new vertebral fractures.
Women who entered the study with the lowest BMD experienced the greatest
percentage increase in BMD, but the absolute changes in BMD (as measured in
grams per square centimeter) were similar in all of the treatment groups.
The study participants were 1,637 white women with a mean age of approximately
70 years. They had at least one moderate or two mild atraumatic vertebral
fractures and a minimum of seven evaluable nonfractured vertebrae. Women with a
hip or vertebral T score < –1 also were included, even if they had no evidence
of vertebral fractures. Overall, the mean T score of all study participants was
–2.6, and they had a mean of 2.3 prevalent fractures, the investigators
commented.
The women were divided into three groups: 541 self-administered an injection of
teriparatide in a dose of 20 µg/day; 552 took 40 µg teriparatide/day; and 544
injected a placebo. All of the women also took 1,000 mg/day of calcium and
400-1,200 IU vitamin D/day for the length of the study, the duration of which
was 19 months.
Compared with the placebo group, women in the 20 µg and 40 µg of teriparatide
groups experienced a 10% and 14% increase in vertebral BMD, respectively. The
increased bone density was associated with a reduction of 65% and 69%,
respectively, in the incidence of new vertebral fractures.
To evaluate the relationship between teriparatide treatment and age, the
investigators divided the women into three age groups: younger than 65; from 65
to less than 75 years; and 75 or older. Teriparatide significantly increased BMD
across all age groups, although the percentage increase was greatest in the
oldest women, perhaps because the study was overpowered with respect to analysis
of BMD (J. Bone Miner. Res. 18[1]:18-23, 2003).
Older women in the placebo group experienced an increase in BMD, compared with
younger women over the course of the study, possibly because they were more
deficient in calcium and vitamin D and benefited more from those supplements,
Dr. Marcus and his associates said.
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Last Modified: Sunday April 06 2003