THOUSAND OAKS, Calif., Oct. 14 /PRNewswire/ -- Amgen (Nasdaq: AMGN) today announced that results from several Prolia™ (denosumab) studies, as well as analyses of the growing global burden of osteoporosis, will be presented at the 2010 American Society for Bone and Mineral Research (ASBMR) annual meeting in Toronto, Ontario from Oct. 15-19, 2010.
"The continued need to reduce fractures caused by postmenopausal osteoporosis is reinforced by data that will be presented at this year's ASBMR meeting. These data highlight the global economic burden associated with osteoporotic fractures, the challenges with adherence to oral therapies, and the link between adherence and fracture outcomes," said Catherine Stehman-Breen, M.D., vice president of Global Development at Amgen. "Additionally, safety and efficacy results from the Prolia FREEDOM extension study will be available along with two new analyses of FREEDOM that evaluated the effect of Prolia on bone strength."
ASBMR abstracts are available and can be viewed online at www.asbmr.org. Identified below are selected abstracts of interest on Amgen research.
Prolia Clinical Data
Hip QCT Results From the FREEDOM Trial: Evidence for Positive BMD/BMC Changes in Integral, Trabecular, and Cortical Bone With Denosumab
Lead Author: Prof. Harry K. Genant, University of California, San Francisco
Abstract No. FR0410 Oral Plenary/Poster Presentation
(Friday, Oct. 15, 5:10 p.m.-5:15 p.m. ET)
Four years of denosumab exposure in women with PMO: Results from the first year extension of the FREEDOM Trial
Lead Author: Socrates Papapoulos, Leiden University Medical Center, The Netherlands
Abstract No. 1025 Oral Presentation
(Saturday, Oct. 16, 10:00 a.m.-10:15 a.m. ET)
Denosumab Improves Both Femoral and Vertebral Strength in Women With Osteoporosis: Results From the FREEDOM Trial
Lead Author: Tony Keaveny, University of California, Berkeley
Abstract No. 1099 Oral Presentation
(Sunday, Oct. 17, 10:00 a.m.-10:15 a.m. ET)
Global and International Health Economic Data
Incremental Cost of Osteoporosis-related Fractures in a Large U.S. Managed Care Population
Lead Author: Hema Viswanathan
Abstract No. MO0404
(Monday, Oct. 18, 11:30 a.m.-1:30 p.m. ET)
Hospitalizations of Major Osteoporotic Fractures in Switzerland between 2000 and 2007
Lead Author: Kurt Lippuner, Osteoporosis Policlinic, University of Bern, Switzerland Abstract No. SU0336
(Sunday, Oct. 17, 11:00 a.m.-1:00 p.m. ET)
Economic burden of osteoporosis-related fracture hospitalizations in France
Lead Author: Milka Maravic, Departement d'Information Medicale, Hopital Leopold Bellan, France
Abstract No. SU0332 Poster Presentation
(Sunday, Oct. 17, 11:00 a.m.-1:00 p.m. ET)
Medication Adherence and Fracture Risk Among Patients Using Osteoporosis Medications in a Large U.S. Health Plan
Lead Author: Sally Wade
Abstract No. SU0398
(Sunday, Oct. 17, 11:00 a.m.-1:00 p.m. ET)
Compliance with Bisphosphonate Therapy and Change in Bone Mineral Density in Clinical Practice
Lead Author: Derek Weycker
Abstract No. SU0397
(Sunday, Oct. 17, 11:00 a.m.-1:00 p.m. ET)
About Osteoporosis: Impact and Prevalence
In the United States (U.S.), one in two women over the age of 50 with postmenopausal osteoporosis will experience a fracture in her remaining lifetime.(1) These fractures can have severe clinical consequences.(2,3) In 2005, osteoporosis-related fractures were responsible for an estimated $19 billion in costs and by 2025 experts predict that these costs will rise to approximately $25 billion.(4,5)
Postmenopausal women with osteoporosis who have experienced a fracture are at increased risk for another fracture.(6,7,8)
Prolia is approved for use in the U.S., the European Union, Canada, Australia and Switzerland. In the U.S., Prolia is approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Prolia, the first and only FDA-approved RANK Ligand inhibitor, is an every six month 60 mg subcutaneous injection administered by a health care professional.
The pivotal three-year Phase 3 Fracture REduction Evaluation of Denosumab in Osteoporosis every six Months (FREEDOM) study in 7,808 women with postmenopausal osteoporosis demonstrated that Prolia, administered as a 60mg subcutaneous injection every six months, compared with placebo at three years resulted in:
- A 68 percent reduction in vertebral fractures (4.8 percent absolute risk reduction). The incidence of new spine fractures was 2.3 percent with Prolia vs. 7.2 percent with placebo;
- A 40 percent reduction in hip fractures (0.3 percent absolute risk reduction). The incidence of hip fractures was 0.7 percent with Prolia vs. 1.2 percent with placebo;
- A 20 percent reduction in non-vertebral fractures (1.5 percent absolute risk reduction). The incidence of non-spine fractures was 6.5 percent with Prolia vs. 8 percent with placebo;
- Significant bone density increases at all key sites measured (8.8 percent at the lumbar spine, 6.4 percent at the total hip, and 5.2 percent at the femoral neck).
Prolia is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating Prolia. Hypocalcemia may worsen, especially in patients with severe renal impairment. All patients should be adequately supplemented with calcium and vitamin D.
In the pivotal study, serious infections leading to hospitalizations were reported more frequently in the Prolia-treated patient group. Serious skin infections, as well as infections of the abdomen, urinary tract and ear, were more frequent in patients treated with Prolia. Patients should be advised to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis. Endocarditis was reported more frequently in the Prolia-treated patient group. Epidermal and dermal adverse events such as dermatitis, rashes, and eczema have been reported. Discontinuation of Prolia should be considered if severe symptoms develop.
Prolia resulted in significant suppression of bone remodeling. The significance of these findings is unknown. The long-term consequences of the degree of suppression of bone remodeling observed with Prolia may contribute to adverse outcomes such as osteonecrosis of the jaw (ONJ), atypical fractures, and delayed fracture healing. ONJ has been reported in patients with Prolia. Patients should be monitored for these adverse outcomes. The most common adverse reactions (> 5 percent and more common than placebo) were back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis. Pancreatitis has also been reported with Prolia.
About Denosumab Collaborations
In July 2009, Amgen and GlaxoSmithKline (GSK) announced a collaboration agreement to jointly commercialize Prolia for postmenopausal osteoporosis in Europe, Australia, New Zealand and Mexico once the product is approved in these countries. Amgen will commercialize Prolia's postmenopausal osteoporosis and oncology indications in the U.S. and Canada and for all oncology indications in Europe and in other specified markets.
In addition, GSK will register and commercialize denosumab for all indications in countries where Amgen does not currently have a commercial presence, including China, Brazil, India and South Korea but excluding Japan. The structure of the collaboration allows Amgen the option of an expanded role in commercialization in both Europe and certain emerging markets in the future.
Amgen and Daiichi-Sankyo Company, Limited have a collaboration and license agreement for the development and commercialization of denosumab in Japan.
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CONTACT: Amgen, Thousand Oaks
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(1) Osteoporosis Fast Facts. Washington (DC): National Osteoporosis Foundation. Accessed on May 10, 2010 at http://www.nof.org.
(2) National Osteoporosis Foundation. http://www.nof.org. Accessed May 13, 2010.
(3) Cooper C. The crippling consequences of fractures and their impact on quality of life. Am J Med. 1997 Aug 18;103(2A):12S-17S; discussion 17S-19S.
(4) Burge R et al. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res. 2007 Mar;22(3):465-75.
(5) Osteoporosis Fast Facts. Washington (DC): National Osteoporosis Foundation. Accessed on April 29, 2010 at http://www.nof.org.
(6) Kanis JA et al. A Meta-Analysis of Previous Fracture and Subsequent Fracture Risk. Bone. 2004;35(2):375-82.
(7) Lindsay R et al. Risk of new vertebral fracture in the year following a fracture. JAMA. 2001 Jan 17;285(3):320-33.
(8) Klotzbuecher CM et al. Patients with prior fractures have an increased risk of future fractures: a summary of the literature and statistical synthesis. J Bone Miner Res. 2000 Apr;15(4):721-39.