
Pictured Above: Forteo disposable dosage pen
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by: Aya Chow
On November 26, 2002, the Food and Drug Administration
approved the first drug designed to stimulate new bone growth.
Teriparatide is groundbreaking as it increases the
amount and activity of osteoblasts, the bone-building cells of the body. All other
older approved osteoporosis drugs work through inhibiting osteoclasts, the
bone-destroying cells.
10 million Americans, 80%
women, are affected by osteoporosis, a condition where the bones weaken and
become more likely to fracture. In the human body, osteoblasts create new bone
cells while osteoclasts destroy worn out bone cells. The two work in balance
and bones remain strong and dense. As the body ages, more activity is generally
seen from osteoclasts, upsetting the balance which can lead to osteoporasis.
Osteoporosis can develop for
years without symptoms, but early detection is possible through bone density
testing available through FORE, the Foundation For Osteoporosis Research and
Education. Their number is 510-832-2663.
It is possible to have
osteoporosis and arthritis at the same time, though some are more prone to
getting osteoporosis than others. Those with rheumatoid arthritis (RA) or lupus
and those taking corticosteroids are at an increased osteoporotic risk.
The recommended dose of
teriparatide is 20 mcg per day given through injection, and it may be used
together with an older approved osteoporosis drug. Side effects reported are
mild and include nausea, dizziness, and leg cramps.
Children, adolescents, persons
with hypercalcemia, Paget’s disease of the bone, or who have ever been
diagnosed with bone cancer or other cancers that have spread to the bones, and
women who are pregnant or nursing, should not use teriparatide.
A “black box” warning by the
FDA point out the possibility that humans treated with teriparatide may have a
small risk of developing osteogenic sarcoma (OSS), a rare but serious cancer of
the bone. No such tumors have been seen in the 2000 human patients tested in
the clinical trials. However a small number of rats did develop OSS. The
possibility of a risk to humans cannot be ignored.
Teriparatide will be marketed
under the trade name Forteo, manufactured by Eli Lilly and Company.