Full Press Release Details
SAN DIEGO , Sept. 19, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY ) today presented a study that assessed the effects of 18 months of treatment with FORTEO ® (teriparatide [rDNA origin] injection) on vertebral and proximal femoral strength, and the relationship of these effects to changes in the underlying volumetric BMD (vBMD) of postmenopausal women with osteoporosis. Researchers concluded that FORTEO increased vertebral and femoral strength in the spine and hip bones compared to baseline. 1 These findings were presented in an oral presentation at the 2011 Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in San Diego, Calif.
"Low bone strength is an important factor in the risk of fracture for patients with osteoporosis," said Tony Keaveny , MD, director, Orthopaedic Biomechanics Laboratory, Department of Mechanical Engineering, University of California, Berkeley . "These data provide supportive evidence that treatment with FORTEO has the potential to increase bone strength in two areas prone to fracture, the hip and spine."
The study used finite element analysis (FEA) of quantitative CT scans to measure changes in vertebral and proximal femoral strength. Although FEA is one of the most widely accepted means of non-invasive bone strength assessments, data are scarce on changes in vertebral and femoral bone strength for patients treated with FORTEO; therefore, the biomechanical effects of FORTEO treatment in postmenopausal women are not well understood. 2
Researchers performed FEA of quantitative CT scans from study participants to measure bone strength and found statistically significant increases in both vertebral and femoral strength in women treated with FORTEO, compared to baseline (median: 16.6 percent and 2.3 percent, respectively, p≤0.05). 3 The results indicated significant increases in both trabecular and peripheral densities in the spine (median: 12.8 percent and 5.8 percent, respectively, p≤0.05) and an increase in trabecular density in the hip (median: 3.9 percent, p≤0.05). 4 There was no observed change in peripheral density in the hip. 4
"These study results are encouraging, as they provide additional evidence that FORTEO treatment may result in increased bone strength in appropriate patients," said Kelly Krohn , MD, Eli Lilly and Company. "Studies that reinforce the already established efficacy of medications can help healthcare professionals determine the right medicine to treat their patients with osteoporosis."
FORTEO is used in both men and postmenopausal women with osteoporosis who are at high risk for having broken bones (fractures). FORTEO is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures). FORTEO can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who cannot use other osteoporosis treatments. 5
FORTEO is a prescription medicine given as a 20 mcg once daily dose available in a 2.4 mL prefilled delivery device for subcutaneous injection over 28 days. 5
During the drug testing process, the medicine in FORTEO caused some rats to develop osteosarcoma, which, in humans, is a serious but rare bone cancer. Osteosarcoma has been reported rarely in people who took FORTEO, and it is unknown if people who take FORTEO have a higher chance of getting the disease. Before patients take FORTEO, patients should tell their healthcare provider if they have Paget's disease of bone, are a child or young adult whose bones are still growing or have had radiation therapy. 5 For more information about FORTEO, please see the important safety information, including Boxed Warning regarding osteosarcoma, below.
About the Study 6
"Increases in both vertebral and femoral strength in postmenopausal osteoporotic women after 18 months of treatment with teriparatide" was an 18-month, open-label study using finite element analysis of quantitative CT scans to analyze the effects of treatment with FORTEO on vertebral and proximal femoral strength.
Quantitative CT scans were taken of the lumbar spine and hip at baseline and at 18 months (or at an early termination visit). All patients who had two evaluable CT scans at both time points were included in the analysis (n=30 spine; n=26 hip).
Volumetric density was measured for the trabecular, peripheral (outer 2-3 mm of bone that contains both cortical and some adjacent trabecular bone) and both ("integral") compartments. Non-linear finite element analysis was performed for uniform compression for the spine and a sideways fall for the hip to provide measures of vertebral and femoral strength.
Important Safety Information about FORTEO
What is the most important information I should know about FORTEO?
| WARNING: POTENTIAL RISK OF OSTEOSARCOMA | |
| During the drug testing process, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma. In people, osteosarcoma is a serious but rare cancer. Osteosarcoma has been reported rarely in people who took FORTEO. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma. Before you take FORTEO, you should tell your healthcare provider if you have Paget's disease of bone, are a child or young adult whose bones are still growing, or have had radiation therapy. |
Who should not take FORTEO?
What should I tell my healthcare provider before taking FORTEO?
What are the possible side effects of FORTEO?
Additional safety information about FORTEO
How should I store FORTEO?
For more safety information, please see Medication Guide ( http://pi.lilly.com/us/forteo-medguide.pdf ) and Prescribing Information, including Boxed Warning ( http://pi.lilly.com/us/forteo-pi.pdf ). Please see full user manual that accompanies the delivery device.
TE Con ISI 07Mar2011
About Eli Lilly and Company
Eli Lilly and Company, a leading innovation-driven company, is developing a growing portfolio of 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. Information about Lilly is available at www.lilly.com . P-LLY
FORTEO ® is a registered trademark of Eli Lilly and Company.
This press release contains forward-looking statements about FORTEO for the treatment of osteoporosis. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that FORTEO will continue to be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
1 Keaveny, T., et al. "Increases in both vertebral and femoral strength in postmenopausal osteoporotic women after 18 months of treatment with teriparatide." Abstract presented at the ASBMR 2011 Annual Meeting, Sept. 19, 2011 , 4:00 PM . <Page 1, Paragraph 4 "Conclusion.">
2 Keaveny, T., et al. "Increases in both vertebral and femoral strength in postmenopausal osteoporotic women after 18 months of treatment with teriparatide." Abstract presented at the ASBMR 2011 Annual Meeting, Sept. 19, 2011 , 4:00 PM . <Page 1, Paragraph 1 "Purpose.">
3 Keaveny, T., et al. "Increases in both vertebral and femoral strength in postmenopausal osteoporotic women after 18 months of treatment with teriparatide." Abstract presented at the ASBMR 2011 Annual Meeting, Sept. 19, 2011 , 4:00 PM . <Page 1, Paragraph 3 "Results.">
4 Keaveny, T., et al. "Increases in both vertebral and femoral strength in postmenopausal osteoporotic women after 18 months of treatment with teriparatide." Abstract presented at the ASBMR 2011 Annual Meeting, Sept. 19, 2011 , 4:00 PM . <Page 2, Table 1.>
5 FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf .
6 Keaveny, T., et al. "Increases in both vertebral and femoral strength in postmenopausal osteoporotic women after 18 months of treatment with teriparatide." Abstract presented at the ASBMR 2011 Annual Meeting, Sept. 19, 2011 , 4:00 PM . <Page 1, Paragraph 2 "Methods.">
SOURCE Eli Lilly and Company