Number, Severity of Fractures, Predicts Future Risk
04 October 2004 - 10:30AM
PR Newswire (US)
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:
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