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) N. Snelder, BSc

Masters student

Life Science and Technology

TU Delft / RU Leiden (Nl)

H. Mulder, MD PhD

Endocrinologist

Director Osteosupport SMO

Rotterdam (Nl)

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

Overview

IntroductionIntroduction

Definition of Bone Mineral Density Definition of Bone Mineral Density

(WHO)(WHO)

Healthy Bone = Reference BMD of 25 yrs old female(T-score < -1)(T-score < -1)

Osteopenic = BMD < 1 SD of reference BMD (T-score < -1)(T-score < -1)

Osteoporotic = BMD < 2.5 SD (T-score < -2.5)(T-score < -2.5)

Introduction

Natural BMD at Hip in Caucasian Females

• 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).

Introduction

Epidemiology of Osteoporosis

Introduction

Bone Mineral Density vs. Risk of Hip fracture

• 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.

Introduction

Cost 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, 2001Chapuy et al. Osteoporos. Int. 2002

Introduction

Prevention of Osteoporosis

IntroductionOsteoporosis & Calcium

• “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

Introduction

Prevention of Osteoporosis

IntroductionOsteoporosis & Exercise:

Background

Vibrations and Bone mass

Animal studies (Turkey)

Rubin et al. Nature 2001

Fritton, McLeod, Rubin, J. Biomech. 2000

Background

Normal Frequency & Microstrain Pattern in Bone

Animal studies (Turkey/Sheep/Dog)

Fritton, McLeod, Rubin, J. Biomech. 2000

Walking Turkey 12 h. Daily activity

1 microstrain is 0.0001% strain (e = dL/L)

Background

Vibrations and Bone mass

Animal studies (Ewes)

Rubin et al. Bone 2002

Rubin et al. J Bone Miner. Res. 2002

30Hz, 0.3 g, 20min/day5x/wk during 1 year

Femur: 34.2% BMD increaseTibia: 26.7% Strength increase

Background

Vibrations and Bone mass

Animal studies: Bone Formation (Prox. Tibia) in Rats

Rubin et al. FASEB 2001

28 days follow up period:

LTC=Long term controlMS=Mech. Stim/ @ 90Hz 0.25 g

10 min/day 5x/wkDis= Disuse Hindlimb suspensionWB=Weight Bearing

Background

Vibrations and Bone mass

Animal studies: Mineralization of Trabuculae

Rubin et al. FASEB 2001

Control Disuse Mech. Stim.

Research Question

What is the effect of Vibration Therapy

on patients with low bone mass?

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

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

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

Galileo ™ 900/2000

Whole Body Vibration Platform

•Amplitude: 0-12 mm

•Frequency 5-30 Hz (continuum)

•Tilting platform

Whole Body Vibration

    

• 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

Whole Body Vibration according to Galileo principle

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)

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%

ResultsSerum Alkaline Phosphates

94,0%

96,0%

98,0%

100,0%

102,0%

104,0%

106,0%

108,0%

110,0%

0 12 24

Months

Serum Alkaline Phosphates

Change Alkaline Phosphates I

Change Alkaline Phosphates II

* * * *

* p<0.01

BMD L1-L4

98,0%

99,0%

100,0%

101,0%

102,0%

103,0%

104,0%

105,0%

106,0%

107,0%

108,0%

0 6 12 24

Months

Change BMD Spine I

Change BMD Spine II

ResultsBMD change Spine

*

*¶ ¶

¶

¶ p<0.01, * p<0.001

BMD Femoral Neck

98,0%

99,0%

100,0%

101,0%

102,0%

103,0%

104,0%

105,0%

106,0%

107,0%

108,0%

0 6 12 24

Months

Change BMD Hip I

Change BMD Hip II

ResultsBMD change Hip

*

* *

¶ p<0.01, * p<0.001

¶

¶¶

ResultsPercentual BMD change

Spine group 1 Hip group 1Months

0 100,0% 100,0%6 101,0% 101,7%

12 101,8% 103,3%24 102,1% 103,6%

Spine group 2 Hip group 2Months

0 100,0% 100,0%6 101,3% 102,0%

12 103,1% 104,2%24 104,0% 103,9%

Percental change in bonemass

Percental change in bonemass

I

II**

*

*

¶

*

¶¶

¶¶

¶

¶ p<0.01, * p<0.001

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)

Bone Mineral Density change (DEXA)

100,0%

100,5%

101,0%

101,5%

102,0%

102,5%

103,0%

103,5%

104,0%

104,5%

0 6 12 24months

Spine group 1 Hip group 1 Spine group 2 Hip group 2

ResultsTherapy compliance

Table IV Group Igroup IINote: Medical Vibraion Therapy each weak = 100%

90%93%94%

Compliance to the Whole Body Vibration protocol104 weeks52 weeks

92%

Reported side effects: none

Other Literature8 Months of Vertical WBV @ 25-45 Hz

in young healthy adults vs controls (RCT, n=56)

2-5x/wk, 4 min/day

Torvinen et al, J Bone Miner Res 2003 May 18:876-84

•No effect on BMC (DEXA/pQCT)

•No effect on Serum Bone Turnover Markers

•7.8 % net increase in Jump Height

Other LiteratureStrength training vs. Tilting WBV @ 25 Hz

12 mths, 2x/wk +/- HRT post-menopausal (n=51)

C. Kleinmond, PhD Thesis FU Berlin, 2002 http://darwin.inf.fu-berlin.de/2002/270

SpineSpine

HipHip

DiscussionWhole Body Vibration and Bone Metabolism

•Catabolic vs Anabolic state of Bone

•Secondary/functional hypoparathyreoidism•Pre vs Post menopausal•Base line BMD / Activity level

DiscussionWhole Body Vibration and Bone Metabolism

•Synergistic Effect with

•Ca++/Vit D•Hormone Replacement Therapy

DiscussionWhole Body Vibration and Bone Metabolism

Dose-response relationship ?

•Frequency•Duration•Amplitude•Vertical vs Tilting •Therapy Compliance

DiscussionWhole Body Vibration and Bone Cell

Theoretical Model of Osteogenesis and Vibration:

Perturbation Intermedullary PressurePerturbation Intermedullary PressureFluid flow through bone canuculi /lacunaeFluid flow through bone canuculi /lacunae

Shear Stress Cell Membrane Shear Stress Cell Membrane (>5 microstrain @ 30 Hz)(>5 microstrain @ 30 Hz)

Mechanotransduction Mechanotransduction Cytoskeletal stressCytoskeletal stress

Expression of mRNAExpression of mRNAOsteoblast Osteoblast

expression /activationexpression /activation Weinbaum et al. J. Biomech. 27, 1993Hsich& Turner J Bone Miner Res 16, 2001Rubin et al Nature 412, 200/ Bone 30, 2002

Qin, Rubin, McLeod J Orth Res 16 1998Cullen et al. J. Appl. Physiol 91, 2001

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)

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

Thank you for your attention