Full Press Release Details
SAN DIEGO , Sept. 19, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY ) today presented data comparing the mechanisms of action of FORTEO® (teriparatide [rDNA origin] injection) and zoledronic acid based on data that evaluated histomorphometric measurements of bone remodeling in transiliac crest bone biopsies from postmenopausal women with osteoporosis. These data 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.
Dynamic indices of bone formation, including mineralizing surface/bone surface (MS/BS) and bone formation rate (BFR), were significantly higher in women treated with FORTEO than in women treated with zoledronic acid at six months. 1
“What makes this study important is that it was through the use of a complete panel of bone biopsy indices that we confirmed the differences in the mechanism of action of the two osteoporosis treatments,” said David W. Dempster , PhD, professor of clinical pathology, Columbia University .
The study’s primary objective was to compare the effects of FORTEO or zoledronic acid on MS/BS at six months. MS/BS is a measure of the proportion of bone surface upon which newly mineralized bone is being deposited. 2 Results showed that in women treated with FORTEO, MS/BS was significantly higher than in those treated with zoledronic acid (median: 5.60 percent vs. 0.16 percent; p<0.001).
Secondary outcomes demonstrated:
“We believe that these data make an important contribution to the body of evidence supporting the mechanism of action for FORTEO,” said Kathleen Taylor , PhD, Eli Lilly and Company.
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. 4
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. 4 For more information about FORTEO, please see the important safety information, including Boxed Warning regarding osteosarcoma, below.
About the Study 5
“ S keletal H istomorphometry in Patients O n T eriparatide or Z oledronic Acid Therapy (SHOTZ) Study: 6-Month Results of a Randomized Clinical Trial” was a six-month, randomized, double-blind, cross-sectional biopsy study that compared histomorphometric parameters of bone remodeling in 58 postmenopausal women with osteoporosis. Participants received either 20 μg/d teriparatide (TPTD, n=28) or 5 mg/y zoledronic acid (ZOL, n=30).
The study’s primary endpoint was the comparison of mineralizing surface/bone surface (MS/BS) between treatment groups, assessed by bone histomorphometry in cancellous compartment of iliac crest bone biopsy at month six (obtained after double tetracycline labeling). Secondary endpoints included comparison of bone formation rate (BFR/BS), mineral apposition rate (MAR) and other standard histomorphometric indices in iliac crest bone biopsies at six months; change from baseline to months one, three and six in biochemical markers of bone turnover; and safety evaluations of vital signs, laboratory analyses, pre-biopsy assessments and treatment-related adverse events.
Participants aged 55 to 89 years were enrolled based on bone mineral density (BMD) and fracture criteria as assessed by the investigators.
Important Safety Information about FORTEO
What is the most important information I should know about FORTEO?
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 Dempster, D., et al. “ S keletal H istomorphometry in Patients O n T eriparatide or Z oledronic Acid Therapy (SHOTZ) Study: 6–Month Results of a Randomized Clinical Trial.” Abstract presented at the ASBMR 2011 Annual Meeting, Sept. 19, 2011, 3:45 PM. <Page 3, Table 1.>
2 Moreira Kulak CA, Dempster DW. Bone histomorphometry: a concise review for endocrinologists and clinicians. Arq Bras Endocrinol Metab . 2010;54(2):87-98.
3 Dempster, D., et al. “ S keletal H istomorphometry in Patients O n T eriparatide or Z oledronic Acid Therapy (SHOTZ) Study: 6–Month Results of a Randomized Clinical Trial.” Abstract presented at the ASBMR 2011 Annual Meeting, Sept. 19, 2011 , 3:45 PM . <Page 1, Paragraph 2 “Results.”>
4 FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf .
5 Dempster, D., et al. “ S keletal H istomorphometry in Patients O n T eriparatide or Z oledronic Acid Therapy (SHOTZ) Study: 6–Month Results of a Randomized Clinical Trial.” Abstract presented at the ASBMR 2011 Annual Meeting, Sept. 19, 2011 , 3:45 PM . <Page 1, Paragraph 1 “Purpose.”>
SOURCE Eli Lilly and Company