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Vertebral Compression Fracture Management Series

ADDRESSING THE BURDEN OF VERTEBRAL COMPRESSION FRACTURES

Presented by:

[Name][Title][Institution][Date]

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VCF Management Series

Presentation 1:Understanding the Downward Spiral of Vertebral Compression Fractures

Presentation 2: Vertebral Compression Fractures (VCFs): A New Approach to Treatment

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Understanding the Downward Spiral of

Vertebral Compression Fractures

Presented by:

[Name][Title][Institution][Date]

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Epidemiology and Progression

700,000 vertebral compression fractures (VCFs) occur each year in the U.S.1

Two-thirds of all VCFs go undiagnosed and even fewer are treated1

150,000 people are hospitalized annually due to pain and medical management of VCFs2

1 in 2 women and 1 in 4 men over age 50 will have an osteoporosis-related fracture in her/his remaining lifetime1

1 National Osteoporosis Foundation.2 Riggs BL, Melton LJ III. Bone. 1995;17(5 Suppl):505S-511S.

MRI images of progressivemorphometric changes in thepresence of a vertebralcompression fracture at T-12(the thoracolumbar junction).

January 2003 February 2003 May 2003

Vertebral Fracture ProgressionT-12 Vertebral Compression fracture

Courtesy of Michael Hisey, M.D., Texas Back Institute.

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Increased Pain and Disability

Leidig-Bruckner G et al. J Bone Miner Res. 1997;12:663-675.

*Significantly different from Group 1

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Impaired Pulmonary Function

VCFs and kyphosis caused by osteoporosis deform the thoracic cage and produce predictable declines in pulmonary function

Leech JA et al. Am Rev Respir Dis. 1990;141:68-71.

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Increased Future Fracture Risk With Prior VCF

After first VCF, risk of a subsequent VCF is increased1

– 5-fold after first VCF– 12-fold after > 2 VCFs– 75-fold after > 2 VCFs

and low bone mass (below the 33rd percentile)

1 Ross PD et al. Ann Intern Med. 1991;114:919-923.2 Lindsay R et al. JAMA Int. 2001;285(3):320-323.

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Decreased Health-Related Quality of Life (HRQOL)

Number of VCFs correlates with progressive decreases in HRQOL

Silverman SL et al. Arthritis Rheum. 2001;44:2611-2619.

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Increased Mortality Risk

Women with prevalent VCF had 23% higher age-adjusted mortality rate

Subclinical VCFs in patients unaware of their fracture were associated with a 16% mortality rate

Most common cause of death was pulmonary disease – significantly related to degree of kyphosis

Kado DM et al. Arch Intern Med. 1999;159:1215–1220.

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Need for a New Approach to VCF Management

Increase awareness and diagnosis of VCFs

VCF treatment goals– Relieve pain– Restore anatomy and structural integrity– Restore function– Prevent future fractures and progression of deformity

Traditional palliative management does not treat the deformity and associated decline

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Summary

VCFs are common and can be associated with devastating consequences– Chronic back pain– Reduced pulmonary and physical function– Decreased quality of life– Increased risk of future fractures– Increased overall mortality risk

Important to diagnose VCFs as early as possible to prevent further progression of spinal deformity and the associated consequences

A new approach to VCF management includes restoring structural integrity of the spine and preventing progression of deformity

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ReferencesPRESENTATION 1 – UNDERSTANDING THE DOWNWARD SPIRAL OF VCFs1. Brunton S, Carmichael B, Gold D*, et al. Vertebral compression fractures in primary care: recommendations from a consensus panel. J

Fam Pract. 2005;54:781-788. Supplement supported by an unrestricted educational grant from Kyphon Inc.2. National Osteoporosis Foundation. Available at: www.nof.org/osteoporosis/diseasefacts.htm. Accessed January 29, 2007.3. American Cancer Society. Breast Cancer Facts & Figures 2005-2006. Atlanta: American Cancer Society, Inc.4. Riggs BL, Melton LJ III. The Worldwide Problem of Osteoporosis: Insights Afforded by Epidemiology. Bone. 1995;17(5 Suppl):505S-511S5. Ross PD, Davis JW, Epstein RS, et al. Pre-existing fractures and bone mass predict fracture incidence in women. Annals of Internal

Med. 1991;114:919-923.6. Leech JA, Dulberg C, Kellie S, et al. Relationship of lung function to severity of osteoporosis in women. Am Rev Respir Dis.

1990;141:68-71.7. Gold DT*. The clinical impact of vertebral fractures. Bone. 1996;18(3 Suppl 7):185S-189S.8. Ross PD. Clinical consequences of vertebral fractures. Symposium on osteoporosis. Am J Med.1997;103:30S-43S.9. Silverman SL*, Minshall ME, Shen W, et al. For Health-related quality of life subgroup of the multiple outcomes of raloxifene evaluation

study. The relationship of health-related quality of life to prevalent and incident vertebral fractures in postmenopausal women with osteoporosis. Arthritis Rheum. 2001;44:2611-2619.

10. Kado DM, Browner WS, Palmera L, et al. For the study of Osteoporotic Fractures Group. Vertebral Fractures and Mortality in Older Women. Arch Intern Med. 1999;159:1215-1220.

11. Gold DT*, Silverman SL*. The Downward Spiral of Vertebral Osteoporosis: Consequences. Monograph sponsored by Cedars-Sinai Medical Center. 2003. Study sponsored by Kyphon.

12. Leidig-Bruckner G, Minne HW, Schlaich C, et al. Clinical grading of spinal osteoporosis: quality of life components and spinal deformity in women with chronic low back pain and women with vertebral osteoporosis. J Bone Miner Res. 1997;12:663-675.

13. Lindsay R, Pack S, Li Z. Longitudinal progression of fracture prevalence through a population of postmenopausal women with osteoporosis. Osteoporos Int. 2005;16:306-312.

14. Black DM, Arden NK, Palmero L, et al. Prevalent vertebral deformities predict hip fractures and new vertebral deformities but not wrist fractures. J Bone Min Res. 1993;14:821-828.

15. Van Schoor NM, Smit JH, Twist JWR. Impact of vertebral deformities, osteoarthritis, and other chronic diseases on quality of life: a population based study. Osteoporos Int. 2005;16:749-756.

16. Cauley JA, Thompson DE, Eusrud KC, et al. Risk of mortality following clinical fractures. Osteoporos.2000;11:556-561.

* Paid Kyphon consultant

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Vertebral Compression Fractures (VCFs):

A New Approach to Treatment

Presented by:

[Name][Title][Institution][Date]

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VCF: Associated Conditions

Ismail AA, et al. Osteoporosis Int. 1999; 9:206-213.

Diagnosis of osteoporosis

Glucocorticoid therapy(7.5 mg prednisolone)

Postmenopausal women >age 55

Loss of 2 or more inches in height

Prominent thoracic kyphosis

Low BMD

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Courtesy of B. Boszczyk & R. Bierschnieder, BG Unfallklinik, Dept. of Neurosurgery, Murnau, Germany.

Radiologic Assessment

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Stabilizes the Fracture and Corrects Spinal Deformity caused by one or more VCFs

Balloon Kyphoplasty

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Clinical Outcomes

Vertebral deformity correction and restoration ofspinal anatomy1

Rapid, sustained pain reduction2

Dramatic improvement in activities of daily living2

Significant improvement in quality of life2

Decrease in subsequent fractures and height loss compared to medical management3

Low complication rate <1%4

1Ledlie JT, Renfro MB. Spine. 2006;31:57-64. 2Garfin SR et al. Spine. 2006;31:2213-2220.3Grafe IA et al. Osteoporos Int. 2005;16:2005-2012. 4Quantitative Analysis of Perioperative Complication Rates in Balloon Kyphoplasty and Vertebroplasty. Data on file at Kyphon Inc., December 2006.

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Vertebral Deformity Correction and Restoration of Spinal Anatomy

Ledlie JT, Renfro MB. Spine. 2006;31:57-64.

n = 77 patients completing 2 year follow-up

All follow-up values above are statistically significantly increased compared to baseline (P <.001)

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1 Gaitanis IN et al. Eur Spine J. 2005;14:250-260.2 Crandall D et al. Spine J. 2004;4:418-424.3 Phillips FM et al. Spine. 2003;28:2260-2265.

*Statistically significant decrease from pre-operative (P = .001)**Statistically significant decrease from pre-operative (P <.001)***Statistically significant decrease from pre-operative (P <.0001)

Vertebral Deformity Correction and Restoration of Spinal Anatomy (cont’d)

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Rapid and Sustained Reduction in Pain

Garfin SR et al. Spine. 2006;31:2213-2220.

All follow-up values are statistically significantly decreased compared to baseline (P <.001)

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Garfin SR et al. Spine. 2006;31:2213-2220.

Improvement in Activities of Daily Living

*Activities of daily living from the index of back function.

All follow-up values above are statistically significantly improved compared to baseline (P <.001)

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Garfin SR et al. Spine. 2006;31:2213-2220.

All follow-up values are statistically significantly improved compared to baseline (P <.0001)

Significant Improvement in Quality of Life Measures

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Improvements Compared WithMedical Management

Komp M et al. J Miner Stoffwechs. 2004;11(suppl 1):13-15.

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1 Komp M et al. J Miner Stoffwechs. 2004;11(suppl 1):13-15. 2 Grafe IA et al. Osteoporos Int. 2005;16:2005-2012.

Improvements Compared WithMedical Management (Cont’d)

11,2

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Summary

VCFs should be diagnosed and treated as early as possible

Balloon Kyphoplasty is a minimally invasive option that provides correction of vertebral body deformity and fracture stabilization

Balloon Kyphoplasty has a low complication rate and is associated with improved clinical outcomes– Pain relief– Improvement in activities of daily living– Improved quality of life

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Although the complication rate with Balloon Kyphoplasty has been demonstrated to be low, as with most surgical procedures, there are risks associated with Balloon Kyphoplasty, including serious complications. For complete information regarding indications for use, warnings, precautions, adverse events and methods of use, please reference the devices’ Instructions for Use.

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ReferencesPRESENTATION 2 – VCFs: A NEW APPROACH TO TREATMENT

1. Brunton S, Carmichael B, Gold D*, et al. Vertebral compression fractures in primary care: recommendations from a consensus panel. J Fam Pract. 2005;54:781-788. Supplement supported by an unrestricted educational grant from Kyphon Inc.

2. Ross PD, Davis JW, Epstein RS, et al. Pre-existing fractures and bone mass predict fracture incidence in women. Annals of Internal Med. 1991;114:919-923.

3. Gold DT*, Silverman SL*. The Downward Spiral of Vertebral Osteoporosis: Consequences. Monograph sponsored by Cedars-Sinai Medical Center. 2003. Study sponsored by Kyphon.

4. Garfin SR*, Buckley RA*, Ledlie J*. Balloon kyphoplasty for symptomatic vertebral body compression fractures results in rapid, significant, and sustained improvements in back pain, function, and quality of life for elderly patients. Spine. 2006;31:2213-2220. Study supported by Kyphon Inc.

5. Silverman SL*, Minshall ME, Shen W, et al. For Health-related quality of life subgroup of the multiple outcomes of raloxifene evaluation study. The relationship of health-related quality of life to prevalent and incident vertebral fractures in postmenopausal women with osteoporosis. Arthritis Rheum. 2001;44:2611-2619.

6. National Osteoporosis Foundation. Available at: www.nof.org/osteoporosis/diseasefacts.htm. Accessed January 29, 2007.7. Ledlie JT*, Renfro MB*. Kyphoplasty treatment of vertebral fractures: 2-year outcomes show sustained benefits. Spine. 2006;31:57-64.

Study sponsored by Kyphon Inc.8. Grafe IA, Da Fonseca K, Hillmeier J, et al. Reduction of pain and fracture incidence after kyphoplasty: 1-year outcomes of a prospective

controlled trial of patients with primary osteoporosis. Osteoporos Int. 2005;16:2005-2012. Study partly sponsored by Kyphon Inc.9. Phillips FM*, Ho E, Campbell-Hupp M, et al. Early radiographic and clinical results of balloon kyphoplasty for the treatment of

osteoporotic vertebral compression fractures. Spine. 2003;28:2260-2267. Research funding was provided by Kyphon Inc.10. Gaitanis IN, Hadjipavlou AG, Katonis PG, et al, Patwardhan AG. Balloon kyphoplasty for the treatment of pathological vertebral

compression fractures. Eur Spine J. 2005;14:250-260. 11. Crandall D*, Slaughter D, Hankins PJ, et al. Acute versus chronic vertebral compression fractures treated with kyphoplasty: early

results Spine J. 2004;4:418-424. Study supported by Kyphon Inc.12. Leidig-Bruckner G, Minne HW, Schlaich C, et al. Clinical grading of spinal osteoporosis: quality of life components and spinal deformity

in women with chronic low back pain and women with vertebral osteoporosis. J Bone Miner Res. 1997;12:663-675.13. Leech JA, Dulberg C, Kellie S, et al. Relationship of lung function to severity of osteoporosis in women. Am Rev Respir Dis.

1990;141:68-71. 14. Komp M, Ruetten S, Godolias G. Minimally invasive therapy for functionally unstable osteoporotic vertebral fracture by means of

kyphoplasty. J Miner Stoffwechs. 2004;11(suppl 1):13-15.

* Paid Kyphon consultant

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