Two new research reports suggest
a link between some bone-building drugs and irregular
heart rhythms in a small number of women who use them.
The problem is most pronounced with Reclast,
a drug given through a once-a-year, 15-minute intravenous
infusion. But researchers also focused on similar problems
in women taking the leading osteoporosis pill, Fosamax,
leading experts to express cautions about giving the
drugs to those who also are at risk for a condition
called atrial fibrillation, an irregular heart rhythm
that can cause strokes.
The two separate reports, published
in the May 3, 2007 issue of the New England Journal
of Medicine (NEJM) point to elevated rates of
serious episodes of atrial fibrillation in women who
took either Reclast or Fosamax.
“For the first time, there
may be a side effect,” said a researcher involved
in both studies, Dr. Steven Cummings of the California
Pacific Medical Center Research Institute. Until now,
people have assumed Fosamax “was completely
safe and could be given to almost anybody.”
There appeared to be 50 percent more
risk of the serious heart rhythm in women who took
the daily pill than among those who didn't take it.
About half of the 6,459 women took Fosamax;
of these 47 developed atrial fibrillation, compared
with just 31 cases among the other women.
While the finding is not statistically
definitive for Fosamax, the numbers worried
some researchers because it is in line with the results
of a new study published in the same issue of the medical
journal.
That study of 7,736 postmenopausal
women with bone-thinning osteoporosis focuses on Reclast,
known generically as zoledronic acid. Currently approved
for Paget’s disease, another bone condition,
the manufacturer, Novartis AG, hopes to get approval
later this year to sell it for osteoporosis use. The
new study, financed by Novartis, shows that Reclast works
at least as well as existing drugs in the same class,
researchers say. However, the risk of a serious case
of irregular heart rhythm was more than double that
in the other patients – 50 cases in the drug-taking
half, compared with 20 cases in the others.
OsteoPhase:
Restoring Calcium Balance to Support Bone Health
OsteoPhase is the first modern nutritional
formula to safely and reliably aid in rebuilding skeletal
bone and resolving calcium overload. Preliminary clinical
findings indicate that OsteoPhase regulates
calcium to benefit conditions such as osteoporosis,
hyperglycemia and other calcium-related disorders.
In safety evaluation trials OsteoPhase was
found to dramatically restore bone mass density – in
some cases to levels consistent with those of a healthy
30-year old female (Fig. 1).
Research indicates that the OsteoPhase regulates
calcium balance (homeostasis) by increasing bone density
and normalizing (reducing) calcium levels in the blood
and cells. These physiological effects are well supported
by independent studies of the herbal ingredients contained
in the formula. OsteoPhase exerts its benefits
while providing less than 125 mg. of calcium per day – far
below the 1000 to 1500 mg. recommended in the US – indicating
that OsteoPhase works
by regulating calcium homeostasis, not by calcium supplementation.
References
1. Juliet Compston, M.D., F.R.C.P.,
F.R.C.Path., F.Med.Sci. Treatments for Osteoporosis — Looking
beyond the HORIZON. NEJM, Vol. 356:1878-1880, May 3,
2007, Number 18.
2. Dennis M. Black, Ph.D., Pierre D. Delmas, M.D.,
Ph.D., Richard Eastell, M.D, et al. Once-Yearly Zoledronic
Acid for Treatment of Postmenopausal Osteoporosis.
NEJM, Vol. 356:1809-1822, May 3, 2007, Number 18.
