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 Ontario government invests in bone health

-First and only osteoporosis therapy with vitamin D is now fully covered by the Ontario government -

Toronto, Ontario (January 10, 2007)   FOSAVANCE® (ALENDRONATE SODIUM 70 MG/CHOLECALCIFEROL 2800 IU [VITAMIN D3]), the first and only therapy to combine FOSAMAX®, the world’s leading osteoporosis treatment, and vitamin D, an important component in treating osteoporosis, is now fully reimbursed by the Ontario Drug Benefit (ODB) formulary.  Dosed as a single, once-weekly tablet, FOSAVANCE® is indicated for the treatment of osteoporosis in postmenopausal women and men.

Anchored by the latest in evidence-based medicine, today’s announcement is heralded by Osteoporosis Canada as an “advance” in osteoporosis care and management for Ontarians and even Canada. “It is well-documented that improved access to  effective medications leads to significant reductions in health care costs and increases in quality of life for those living with osteoporosis in Ontario," says Karen Ormerod, President & CEO of Osteoporosis Canada.

Considered a public health victory for many Ontarians, Canada’s Association for the Fifty-Plus (CARP) hopes this decision will impact the current level of care for osteoporosis in Ontario, which is estimated to be responsible for 68,000 emergency department visits, 62,000 hospitalizations and 14,000 deaths, according to the Institute of Clinical Evaluative Sciences (ICES).[1] In fact, the Osteoporosis Action Plan: An Osteoporosis Strategy for Ontario, (a report of the Osteoporosis Action Plan committee that was submitted to the Ontario Ministry of Health and Long-Term Care) states that if more people with osteoporosis had better access to effective therapies, Ontario would be able to reduce the number of fractures and increase the quality of life for thousands.[2]

Despite the fact that the Ontario Guidelines for the Prevention and Treatment of Osteoporosis suggest alendronate as a recommended treatment option, in the past, patients (seniors with no private coverage or those on fixed incomes) in Ontario were forced to pay out-of-pocket for it.[3]   “Until now, patients who relied on Ontario’s drug plan could only be fully reimbursed for an older osteoporosis medication with a limited body of efficacy data,” says Dr. Aliya Khan, Professor of medicine, Divisions of Endocrinology and Geriatrics at McMaster University and Director of the Calcium Disorders Clinic at St. Joseph’s Healthcare at McMaster University in Hamilton, Ontario.

Access to treatment

Even though research has shown that up to one in five women who suffer a hip fracture dies within one year,[4] osteoporosis remains a “silent killer” because those at-risk cannot see or feel the thinning of their bones. As a result, many patients do not appreciate the long-term benefit of the drugs they are taking and will often discontinue treatment.

“Patients need access to sustained treatment to maintain healthy bone density.  In my practice, cost coverage is often a significant factor for discontinuation which can be as high as 50 per cent after one year of treatment for patients without private coverage,” says Dr. Khan.  “Now that the province of Ontario is fully covering FOSAVANCE, we should see better outcomes among this patient population when it comes to bone health. This decision should be applauded.”

Fracture prevention and alendronate

According to a recent report conducted by the Canadian Agency for Drugs and Technologies in Health, alendronate showed reductions in risks of non-vertebral fractures, hip fractures as well as wrist fractures.[5]   Additionally, the report cited alendronate as a more cost-effective option for women 80 years of age and older because of an increase in the risk of fracture among this age group.[6]

Other data also confirm the efficacy of alendronate. According to numerous studies, alendronate sodium has demonstrated consistent and substantial reductions in hip[7],[8],[9]  and spine fractures[10],[11],[12],[13], as well as substantial increases in bone mineral density (BMD),the amount of calcium contained in bone,[14],[15],[16] and reductions in bone turnover (the rate at which bone is lost).[17], [18]

Vitamin D is essential to calcium absorption

Vitamin D is an essential component of osteoporosis treatment and plays a vital role in ensuring the body can absorb calcium from diet and/or supplements.  However, vitamin D inadequacy and non-compliance continue to be significant issues in Canada, especially among people with osteoporosis.  In fact, more than 60 per cent of Canadians with osteoporosis are not getting enough vitamin D.[19]  Dosed as a single, once-weekly tablet, FOSAVANCE® with 2800 international units (IU) of vitamin D3 provides the assurance that patients are receiving a significant portion of the Canadian recommended intake of vitamin D. 

 Discovering Today for a Better Tomorrow

At Merck Frosst, patients come first.  Merck Frosst Canada Ltd. is a research-driven pharmaceutical company.  Merck Frosst discovers, develops and markets a broad range of innovative medicines to improve human health.  Merck Frosst is one of the top 20 R&D investors in Canada, with an investment of $117 million in 2004.  The Company is committed to fostering partnerships to deliver the most valuable health outcomes for Canadian patients.   More information about Merck Frosst is available at http://www.merckfrosst.com

FOSAVANCE®   Registered Trademark Merck & Co., Inc.  Used under license.

FOSAMAX®   Registered Trademark Merck & Co., Inc.  Used under license.

For more information, please contact:

Ethan Pigott
Cohn & Wolfe
(416) 924-5700 ext. 4059
ethan_pigott@ca.cohnwolfe.com
  Marlene Gauthier
Manager, Public Affairs, Merck Frosst
(514) 428-3057
marlene_gauthier@merck.com


References

[1]Osteoporosis Action Plan: An Osteoporosis Strategy for Ontario, February 2003. Stats for 2003 to 2007, p. 2

[2]Osteoporosis Action Plan: An Osteoporosis Strategy for Ontario, February 2003, p. 3

[3]Ontario Guidelines for the prevention and Treatment of Osteoporosis, Published Fall 2000. Ontario Program for Optimal Therapeutics.

[4]Bone HG, Hosking D, Devogelaer J-P et al. Ten year experience with alendronate for osteoporosis treatment in postmenopausal women. N Engl J Med 2004;350(12):1189-99.

[5]Boucher M, Murphy G, Coyle D, Cranney A, Husereau D, Perras C, Peterson J, Robinson V, Shea B, Skidmore B, Tahar AH, Tugwell P, Wells GA. Bisphosphonates and teriparatide for the prevention of osteoporotic fractures in postmenopausal women [Technology overview no 22]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2006.

[6]Boucher M, Murphy G, Coyle D, Cranney A, Husereau D, Perras C, Peterson J, Robinson V, Shea B, Skidmore B, Tahar AH, Tugwell P, Wells GA. Bisphosphonates and teriparatide for the prevention of osteoporotic fractures in postmenopausal women [Technology overview no 22]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2006.

[7]Black DM, Cummings SR, Karpf DB, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 1996; 348:1535-41.

[8]Cranney A, Wells G, Willan A, Griffith L, Zytaruk N, Robinson V, Black D, Adachi J, Shea B, Tugwell P, Guyatt G, The Osteoporosis Methodology Group, The Osteoporosis Research Advisory Group 2002 II. Meta-analysis of alendronate for the treatment of postmenopausal women. Endocr Rev 2002;23:508-516.

[9]Black DM, Thompson DE, Bauer DC, Ensrud K, Musliner T, Hochberg MC, et al. Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial. FIT Research Group. J Clin Endocrinol Metab 2000;85:4118-24

[10]MSD data on file

[11]Levis S, Quandt SA, Thompson D et al, for the FIT Research Group. Alendronate reduces the risk of multiple symptomatic fractures: Results from the Fracture Intervention Trial. J Am Geriatr Soc 2002; 50(3):409-415.

[12]Reid IR, Brown JP, Burckhardt P et al. Intravenous zolendronic acid in postmenopausal women with low bone mineral density. N Engl J Med 2002; 346(9):653-661.

[13]Cranney A, Guyatt G, Griffith L et al. IX. Summary of meta-analyses of therapies for postmenopausal osteoporosis. Endocr Rev 2002;23(4):570-578.

[14]Pols HAP, Felsenberg D, Hanley DA et al, for the Alendronate sodium 70 mg International Trial Study Group. Multinational, placebo-controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: the FOSIT study. Alendronate sodium 70 mg International Trial Study Group. Osteoporos Int 1999; 9(5):461-468.

[15]Bone HG, Hosking D, Devogelaer J-P et al. Ten year experience with alendronate for osteoporosis treatment in postmenopausal women. N Engl J Med 2004; 350(12):1189-1199.

[16] Sambrook PN, Geusens P, Ribot C, et al. Alendronate produces greater effects than raloxifene on bone density and bone turnover in postmenopausal women with low bone density: results of EFFECT (Efficacy of ALENDRONATE SODIUM 70 mg versus EVISTA Comparison Trial) International. J Intern Med. 2004 Apr; 255(4):503-11.

[17]Black DM, Cummings SR, Karpf DB, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 1996; 348:1535-41

[18]Bone HG, Hosking D, Devogelaer J-P et al. Ten year experience with alendronate for osteoporosis treatment in postmenopausal women. N Engl J Med 2004; 350(12):1189-1199.

[19]SERUM 25 Hydroxyvitamin D level distribution in men and post menopausal women with osteoporosis – F. Chouha

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