Medical Vibration Therapy in Osteopenic patients with Galileo900/2000

1. Medical Vibration Therapy in Osteopenic patients with Galileo900/2000 S.F.E. Praet MD MSc Trainee Sports Medicine Movement Scientist Máxima Medical Centre Veldhoven (Nl) H. Mulder, MD PhD Endocrinologist Director Osteosupport SMO Rotterdam (Nl) N. Snelder, BSc Masters student Life Science and Technology TU Delft / RU Leiden (Nl)

2. Overview • Introduction • Background • Research Question • Methods • The Galileo™ principle • Results • Discussion • Summary

3. Introduction Definition of Bone Mineral Density (WHO) • Healthy Bone = Reference BMD of 25 yrs old female (T-score < -1) • Osteopenic = BMD < 1 SD of reference BMD • (T-score < -1) • Osteoporotic = BMD < 2.5 SD • (T-score < -2.5)

4. Introduction Natural BMD at Hip in Caucasian Females

5. Introduction Epidemiology of Osteoporosis • Approximately 30% of postmenopausal females have osteoporosis according to the World Health Organization (WHO) (Kanis 1994, WHO 1994). • The excess mortality associated with a hip fracture has been estimated to be at 20% (Cooper 1993), • Cumulative lifetime fracture risk for a 50 year-old women may be as high as 60% (Cummings 1989).

6. Introduction Bone Mineral Density vs. Risk of Hip fracture

7. Introduction Cost of Osteoporosis • The total dollar cost of osteoporosis was estimated at seven to ten billion annually in 1988 (WHO 1994). • Hip fractures and hospitalization for all types of fracture accounted for most of these costs (Cooper 1993). • Therefore, the prevention of fractures is the primary goal of intervention.

8. Introduction Prevention of Osteoporosis • Anti-resorptive bone formation agents (e.g. estrogen and biophosphates) • Bone formation agents (e.g. fluoride and PTH). • Calcium and Vitamin D supplementation JAMA 285: 785-795, 2001 Chapuy et al. Osteoporos. Int. 2002

9. Introduction Osteoporosis & Calcium

10. Introduction Prevention of Osteoporosis • “The value of exercise as an intervention for the prevention of postmenopausal bone loss is a controversial subject” Kanis, WHO Study Group. Osteoporosis Int. 1994

11. Introduction Osteoporosis & Exercise:

12. Background Vibrations and Bone mass Animal studies (Turkey) Rubin et al. Nature 2001 Fritton, McLeod, Rubin, J. Biomech. 2000

13. Background Normal Frequency & Microstrain Pattern in Bone Animal studies (Turkey/Sheep/Dog) Walking Turkey 12 h. Daily activity 1 microstrain is 0.0001% strain (e =dL/L) Fritton, McLeod, Rubin, J. Biomech. 2000

14. Background Vibrations and Bone mass Animal studies (Ewes) 30Hz, 0.3 g, 20min/day 5x/wk during 1 year Femur: 34.2% BMD increase Tibia: 26.7% Strength increase Rubin et al. Bone 2002 Rubin et al. J Bone Miner. Res. 2002

15. Background Vibrations and Bone mass Animal studies: Bone Formation (Prox. Tibia) in Rats 28 days follow up period: LTC=Long term control MS=Mech. Stim/ @ 90Hz 0.25 g 10 min/day 5x/wk Dis= Disuse Hindlimb suspension WB=Weight Bearing Rubin et al. FASEB 2001

16. Background Vibrations and Bone mass Animal studies: Mineralization of Trabuculae Control Disuse Mech. Stim. Rubin et al. FASEB 2001

17. Research Question What is the effect of Vibration Therapy on patients with low bone mass?

18. Methods Subjects Selection • Inclusion Criteria: • Osteopenia: BMD –2.0 < t-value < 1.0 (DEXA) • Able to stand on vibration platform • Motivation to participate • Exclusion Criteria: • Use of Medication that influences Bone metabolism • History of Deep Venous Thrombosis

19. Methods Subjects Selection • January 2001- April 2001 • 60 patients visiting Osteoporosis Clinic for DEXA measurement with osteopenia (-2.0 < t < -1.0) • 37 patients included • 23 patients excluded • 10 not allowed medication • 3 History of DVT • 3 Disabled • 7 Not interested to participate

20. Methods Therapeutical Intervention through Randomization • Group I (n=19 (13 F / 6 M) • Age: 61 yrs ± 7 • 10 post menopausal • WBV on Galileo2000 • 1x/week: 3 x 3 min @16 Hz • Group II (n=18 (13 F / 5 M) • Age: 64 yrs ± 5 • 8 post menopausal • WBV on Galileo2000 • 1x/week: 3 x 3 min @16 Hz • Vitamin D 400 I.U. / day • Calcium 500 mg / day

21. Whole Body Vibration Platform Galileo ™ 900/2000 • Amplitude: 0-12 mm • Frequency 5-30 Hz (continuum) • Tilting platform

22. Whole Body Vibration

23. Whole Body Vibrationaccording to Galileo principle • Downward displacement / Acceleration of leg • Reactive upward force (cf. landing phase) • Dampening through: • Eccentric muscle contraction: • alternating left / right limb + • contralateral trunk muscles • Simultaneous Bone strain

24. Methods BMD measurements • Dual Energy X-Ray Absorptiometry (DEXA) • At 0 – 6 – 12 and 24 months • Lunar DPX-L machine Hip (Neck) Lumbar spine (L1-L4)

25. Methods Marker Bone Growth • Serum Alkaline Phosphatase measurements • At 0 – 12 and 24 months Statistics • Multiple t-tests within and between the two groups • Confidence interval 99%

26. Results Serum Alkaline Phosphates * * * * * p<0.01

27. Results BMD change Spine ¶ * ¶ ¶ * ¶ p<0.01, * p<0.001

28. Results BMD change Hip * ¶ ¶ * * ¶ ¶ p<0.01, * p<0.001

29. Results Percentual BMD change I ¶ * ¶ ¶ ¶ II * * * * ¶ ¶ ¶ p<0.01, * p<0.001

30. Results Percental change in bonemass (spine and femoral neck of the hip) in patients with Osteopenia, treated with WBV without (group 1) and with calcium-vitamin D supplementation (group 2)

31. Results Therapy compliance Reported side effects: none

32. Other Literature 8 Months of Vertical WBV @ 25-45 Hz in young healthy adults vs controls (RCT, n=56) 2-5x/wk, 4 min/day • No effect on BMC (DEXA/pQCT) • No effect on Serum Bone Turnover Markers • 7.8 % net increase in Jump Height Torvinen et al, J Bone Miner Res 2003 May 18:876-84

33. Other Literature Strength training vs. Tilting WBV @ 25 Hz 12 mths, 2x/wk +/- HRT post-menopausal (n=51) Spine Hip C. Kleinmond, PhD Thesis FU Berlin, 2002 http://darwin.inf.fu-berlin.de/2002/270

34. Discussion Whole Body Vibration and Bone Metabolism • Catabolic vs Anabolic state of Bone • Secondary/functional hypoparathyreoidism • Pre vs Post menopausal • Base line BMD / Activity level

35. Discussion Whole Body Vibration and Bone Metabolism • Synergistic Effect with • Ca++/Vit D • Hormone Replacement Therapy

36. Discussion Whole Body Vibration and Bone Metabolism • Dose-response relationship ? • Frequency • Duration • Amplitude • Vertical vs Tilting • Therapy Compliance

37. Discussion Whole Body Vibration and Bone Cell • Theoretical Model of Osteogenesis and Vibration: • Perturbation Intermedullary Pressure • Fluid flow through bone canuculi /lacunae • Shear Stress Cell Membrane • (>5 microstrain @ 30 Hz) • Mechanotransduction • Cytoskeletal stress • Expression of mRNA • Osteoblast expression /activation Weinbaum et al. J. Biomech. 27, 1993 Hsich& Turner J Bone Miner Res 16, 2001 Rubin et al Nature 412, 200/ Bone 30, 2002 Qin, Rubin, McLeod J Orth Res 16 1998 Cullen et al. J. Appl. Physiol 91, 2001

38. WBV and Fall risk • ADL in Geriatric patients (Balance + chair rising test) (n=34, 67 yrs; 2 mths: 3x/wk 3 x 2 min WBV) + 18 % progress in Chair rising test Runge et al. ; J. Musculoskeletal Interact. 1 (2000)

39. Summary Whole Body Vibration in Osteopenia • Synergistic effect of WBV and Ca++/Vit D Supplementation • Fast response at Femoral Neck • Long term response at Lumbar Spine • Leveling off after 12 months • Optimal dose response? • Fall and fracture risk reduction: still undetermined

40. Thank you for your attention