Tous Actualités
Suivre
Abonner Eli Lilly and Company

Eli Lilly and Company

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 reforming, a process referred to as bone turnover.
Osteoporosis can occur when bone breakdown exceeds bone formation.
"In most cases, rapid bone turnover can be dangerous and lead to
fracture in osteoporotic patients," said the study's primary
investigator, Pierre Delmas, M.D., Claude Bernard University of Lyon,
France. "In this study, regardless of whether patients had high
turnover rates before being treated, we saw a reduced risk of
fractures with teriparatide."
This posthoc analysis examined biochemical markers of bone
turnover, which provide information about the rate of bone turnover.
This rate can vary considerably in postmenopausal women with
osteoporosis. In this study, the impact of the pretreatment bone
turnover rate on the response to teriparatide was examined.(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 whether rate of bone turnover has an impact on the
effect of teriparatide, this analysis looked at the relationship
between baseline biochemical markers of bone turnover and the ability
of teriparatide to reduce the occurrence of fractures.(1)
Five biochemical markers from postmenopausal women with
osteoporosis who participated in the pivotal Forteo Fracture
Prevention Trial were analyzed.(1)
The Fracture Prevention Trial (FPT), a registration trial for
Forteo, was a randomized, double-blinded, placebo-controlled study
that enrolled 1,637 women with osteoporosis. Subjects were randomized
to teriparatide 20 micrograms/day (marketed as Forteo), teriparatide
40 micrograms/day or placebo for a median of 19 months.(1)
A subset of 520 women had biochemical markers of bone turnover
(serum bone-specific alkaline phosphatase [BSAP], serum
carboxy-terminal extension peptide of procollagen type 1 [PICP],
urinary N-terminal telopeptide [NTX and urinary free
deoxypyridinoline [DPD]) measured at baseline. A partially
overlapping subset of 771 women also had serum amino-terminal
extension of peptide of procollagen type 1 [PINP] evaluated at
baseline. BSAP, PICP and PINP are all markers of bone formation,
whereas DPD and NTX are markers of bone resorption.(1)
Analysis found that subjects with higher baseline concentrations
of BSAP, PINP, NTX and DPD had a higher risk of a new fragility
fracture. Teriparatide significantly reduced the risk of vertebral
and nonvertebral fragility fractures regardless of pretreatment bone
turnover, according to study results.(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. Delmas et al. Fracture Risk Reduction During Treatment with
       Teriparatide is Independent of Pretreatment Bone Turnover 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: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
PRN Photo Desk, photodesk@prnewswire.com

Plus de actualités: Eli Lilly and Company
Plus de actualités: Eli Lilly and Company