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Eli Lilly and Company

Number, Severity of Fractures Predict Future Risk

Indianapolis (ots/PRNewswire)

- New Analysis Showed Teriparatide Prevented Fracture Risk
Associated with Increasing Number, Severity of Osteoporotic Fractures
Data presented at the American Society for Bone and Mineral
Research (ASBMR) 26th annual meeting in Seattle, Wash., showed 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
protection against this risk.(1)
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 established
osteoporosis who were given placebo or teriparatide 20 micrograms.
Patients in the placebo arm who had an 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
teriparatide.(1)
Forteo(R) (teriparatide [rDNA origin] injection), the first and
only bone formation agent approved for the treatment of osteoporosis,
received FDA approval in November 2002 and was granted European Union
(EU) approval in June 2003 and marketed there as Forsteo(R). It
stimulates new bone formation by increasing the number and activity
of bone-forming cells called osteoblasts. In the EU, Forsteo is
licensed for the treatment of established osteoporosis in
postmenopausal women who are at high risk of fracture at 20
micrograms, once daily for 18 months by subcutaneous injection.
Until the approval of Forteo, 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. Following cessation of Forteo therapy, patients
may be continued on antiresorptive therapy.
How Forteo Works
The mechanism by which bone is constantly renewed is called bone
remodeling. Forteo, a fragment of the natural parathyroid hormone
protein found in the body, acts in a novel way on the bone remodeling
process so that new bone is generated and added to the skeleton
faster than old bone is broken down. This anabolic action occurs when
Forteo is administered once daily and is in contrast to current
osteoporosis treatments that only work to slow or stop bone loss. By
acting in this novel way, Forteo increases bone strength and
significantly reduces fracture risk.(2)
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 was collected, and new
nonvertebral fractures occurring during the trial were tabulated.(1)
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
percent, 12.9 percent, and 28.4 percent, 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
percent, 8.2 percent, and 18 percent, respectively.(1)
These significant trends for escalating risk of new fractures in
women with increasing prior fracture burden were not observed in
women treated with Forsteo.(1)
Side Effect Profile
In studies with teriparatide, the most frequent treatment-related
adverse events were generally mild to moderate, dose related and did
not differ statistically from placebo. The most frequently reported
symptoms were nausea, arm and leg pain, headache and dizziness.
Development of this investigational drug was suspended in December
1998 to evaluate a carcinogenicity study in rodents. In the study,
rats exposed to near-lifetime treatment with teriparatide developed
bone tumors, including osteosarcomas. No bone tumors occurred in
human patients in the clinical trials. A comprehensive assessment by
external oncology experts and company researchers indicated that the
finding in rats was unlikely to predict an increased risk of
osteosarcoma for humans receiving teriparatide for the intended
clinical use. This conclusion was based, in part, on several
important differences between rat and human bone biology and
responses to teriparatide.
A Critical Need
Osteoporosis is a global problem, affecting more than 150 million
people worldwide. One in three postmenopausal women will be affected
by osteoporosis,(3) and as the population of the world both grows and
ages, it is becoming an increasingly significant cause of mortality
and morbidity.(4) Studies suggest that osteoporosis may be a quickly
progressing disease once a fracture occurs. The accumulation of
multiple spinal fractures may result in pain, height loss, deformity,
functional limitations and diminished quality of life.(5) The
condition costs national treasuries in the EU more than EUR4.8
billion annually in hospital health care alone.(3)
Lilly is committed to providing "Answers that Matter" to address
the unmet needs of women at risk for or diagnosed with osteoporosis.
In fact, Lilly is also responsible for developing and making
available Evista(R), the first selective estrogen receptor modulator
(SERM) for the prevention and treatment of osteoporosis in
postmenopausal women.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of 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.
References
    (1)    Krege et al. Teriparatide Prevents the Fracture Risk
           Associated with Increasing Number and Severity of
           Osteoporotic Fractures Abstract presented at the 26th
           American Society for Bone and Mineral Research (ASBMR)
           Meeting, October 1-5, 2004, Seattle, Washington, USA
    (2)    Forsteo Summary of Product Characteristics
    (3)    International Osteoporosis Foundation "Call to Action"
           Report 2001
    (4)    International Osteoporosis Foundation Annual Report 1998
    (5)    Boning Up on Osteoporosis: A Guide to Prevention and
           Treatment. National Osteoporosis Foundation; 2000
           SPECIFICS OF THIS DOCUMENT MUST BE REVIEWED BY LOCAL
        MEDICAL/REGULATORY/LEGAL PROCESS TO REFLECT ACCEPTABLE DATA
             DISSEMINATION UNDER LOCAL LAWS AND REGULATIONS
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )

Contact:

Sondra McQueary of Lilly Global, +1-317-985-4045; or Saoyuth Nidh of
MS&L, +44-207-878-3000 ; Photo: NewsCom:
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Plus de actualités: Eli Lilly and Company
Plus de actualités: Eli Lilly and Company
  • 06.10.2004 – 17:11

    Analysis Shows Teriparatide Reduces Fracture Risk Independent of Bone Turnover

    Indianapolis (ots/PRNewswire) - Data presented at the 26th annual meeting of the American Society for Bone and Mineral Research (ASBMR), Seattle, Wash., shows that the ability of teriparatide to prevent fractures remained consistent regardless of pretreatment bone turnover status.(1) Bone is living tissue that constantly regenerates itself by breaking down and ...