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NEW YORK (Reuters Health) Jan 13 - Among postmenopausal
women with calcium and vitamin D insufficiencies who are treated
with alendronate, supplementation with calcium and vitamin D may
help achieve rapid reduction of bone remodeling, according to a
report in the December issue of Clinical Drug Investigation.
In a randomized, double-blind study, Dr. Michel Brazier,
of Faculte de Pharmacie, Amiens, France, and colleagues compared
the biological effects of supplementation with vitamin D and calcium
versus calcium alone during the first 3 months of alendronate treatment
in 48 osteopenic or osteoporotic women with vitamin D and calcium
insufficiency. The women had a mean age of 70 years and were at
least 5 years postmenopause.
Twenty-three subjects received 10 mg alendronate once-daily
supplemented with calcium and vitamin D twice-daily for 3 months.
Twenty-five patients received 10 mg alendronate and a placebo with
calcium alone. The team obtained blood, serum, and urine samples
to measure calcemia, intact parathyroid hormone (I-PTH), and the
N- and C-terminal telopeptides of type I collagen (NTX and CTX),
markers of bone remodeling.
The patients who received supplementation with calcium
and vitamin D experienced a rapid increase in 25-OHD levels. There
were no changes in calcemia or I-PTH levels. Serum and urinary CTX
and urinary NTX were significantly decreased after as little as
15 days of treatment in both groups. These levels remained decreased
throughout the course of alendronate treatment.
Treatment effects, as measured by the Hodges-Lehmann
nonparametric estimator, were consistently greater in the women
who received calcium plus vitamin D than in the women who received
calcium alone, and approached statistical significance after 1 month
of treatment, Dr. Brazier and colleagues explain.
Because of the current study limitations, the investigators
recommend that a larger, longer-term study, including bone mass
density measurements and a control group, be conducted to assess
the value of calcium and vitamin D supplementation combined with
alendronate.
However, they suspect that "such supplementation may
be clinically relevant in osteoporotic postmenopausal women treated
with a biphosphate."
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