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Number, Severity of Fractures, Predicts Future Risk
New Analysis Showed Teriparatide Prevented Fracture Risk Associated With
Increasing Number, Severity of Osteoporotic Fractures
SEATTLE, Oct. 3 /PRNewswire-FirstCall/ -- Data presented today at the American
Society for Bone and Mineral Research (ASBMR) 26th annual meeting show that the
number and severity of prior fractures are strong predictors of future
fractures in postmenopausal women with osteoporosis, and that FORTEO(R)
(teriparatide [rDNA origin] injection) offered patients important protection
against this risk.
This new analysis of the Fracture Prevention Trial (initial results published
in the New England Journal of Medicine, May 2001) included a subgroup of 931
postmenopausal women with severe osteoporosis who were given placebo or
teriparatide 20 mcg (marketed as FORTEO). Patients in the placebo arm who had
increasing number or severity of prior fractures had increasing risk for new
vertebral (spine) fractures and for new nonvertebral fragility fractures during
the study. These trends were not observed in women treated with FORTEO.
FORTEO (teriparatide [rDNA origin] injection), the first and only bone
formation agent approved for the treatment of osteoporosis, was granted FDA
approval in November 2002. It stimulates new bone formation by increasing the
number and activity of bone forming cells called osteoblasts. FORTEO is
approved for the treatment of osteoporosis in postmenopausal women who are at
high risk for fracture and to increase bone mass in men with primary or
hypogonadal osteoporosis who are at high risk for fracture. These include men
(and postmenopausal women) with a history of osteoporosis-related fracture, or
who have multiple risk factors for fracture, or who have failed or are
intolerant to previous osteoporosis therapy, based upon physician assessment.
Until FORTEO's approval, the only approved osteoporosis treatments were
antiresorptives, which work mainly to slow or stop bone loss by reducing the
number and action of bone-removing cells called osteoclasts.
About the Analysis
To determine the relationship between baseline fracture history and future
fracture risk, spine radiographs of 931 postmenopausal women with vertebral
fractures were evaluated at baseline (beginning of the study) and after an
average of 21 months. Additionally, the number of prior nonvertebral fractures
were collected, and new nonvertebral fractures occurring during the trial were
tabulated.
Findings showed that in the placebo group, an increasing number and severity of
prior vertebral and nonvertebral osteoporotic fractures were associated with a
significant increase in new fracture risk. In women with mild, moderate, and
severe vertebral fractures at study entry, the risk for vertebral fracture
during the study was 9.6%, 12.9%, and 28.4%, respectively. Additionally, in
women with zero, one, and two or more prior nonvertebral fractures at study
entry, the risk for new nonvertebral fractures was 3.6%, 8.2%, and 18%,
respectively.
These significant trends for escalating risk of new fractures in women with
increasing prior fracture burden were not observed in women treated with
FORTEO.
Important Safety Information about FORTEO
In two-year studies in rats, teriparatide caused an increase in the incidence
of osteosarcoma, a malignant bone tumor, which was dependent on dose and
duration of treatment. Although no case of osteosarcoma has been reported in
the patients who received FORTEO in clinical trials, it is not known if humans
treated with FORTEO are at increased risk for this cancer.
FORTEO should be prescribed only to patients for whom the potential benefits
are considered to outweigh the potential risk. The drug should not be
prescribed for patients at increased baseline risk for osteosarcoma, including
patients with Paget's disease of bone or unexplained elevations of alkaline
phosphatase, children or growing adults, or those who have had prior external
beam or implant radiation therapy involving the skeleton. Additionally,
patients with bone metastases or a history of skeletal malignancies, and those
with metabolic bone diseases other than osteoporosis, should not receive
FORTEO. Patients with high levels of calcium in their blood should not receive
FORTEO due to the possibility of increasing their blood levels of calcium.
In clinical trials, the most frequent treatment-related adverse events reported
at the 20-microgram (mcg) dose approved for marketing were mild, similar to
placebo and generally did not require discontinuation of therapy. Reported
adverse events that appeared to be increased by FORTEO treatment were leg
cramps and dizziness (2.6 and 8 percent, respectively), compared with placebo
(1.3 percent and 5.4 percent, respectively).
FORTEO is supplied in a disposable pen device that can be used for up to 28
days to give once-daily self-administered injections. FORTEO is available in a
20-mcg dose and should be taken for a period of up to 24 months. Lilly has
implemented a risk management program that includes comprehensive measures
regarding the appropriate use of FORTEO in the target patient population. A
Medication Guide explaining the details of the drug to the patient also
accompanies the product. FORTEO also has a black box warning in its package
insert about the osteosarcoma findings in rats during preclinical testing. For
complete prescribing information, please visit http://www.forteo.com/ .
About Osteoporosis
More than 50 percent of all women over the age of 75 are estimated to have
osteoporosis, and due to their advanced age, have a high risk of fracture. In
fact, most American women over the age of 50 will experience one or more
osteoporosis-related fractures during their lifetimes, and women with
osteoporosis who have two or more previous fractures have up to a nine times
greater risk of future fracture compared with women who have not suffered a
previous fracture.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers -- through medicines and information
-- for some of the world's most urgent medical needs. Additional information
about Lilly is available at http://www.lilly.com/ .
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
DATASOURCE: Eli Lilly and Company
CONTACT: Keri S. McGrath of Eli Lilly and Company, cell:
+1-317-457-5613, office: +1-317-651-6001, or email: