Osteoporosis, Hip Fracture and TurboSonic Whole Body Vibration Therapyฎ

 

Osteoporosis is a silent disease that affects 35% of post menopausal white women. (1) From age 50 to age 90, the risk of hip fracture in white women increases 50-fold. The first symptom most often being a fracture. Of all the fractures related to osteoporosis, fracture of the hip has the gravest consequences. The mortality rate in patients with hip fracture is 12–20% higher than in persons of similar age and gender who have not suffered a fracture.(2) Morbidity associated with hip fracture including decreased activity and inability to be self sufficient results in another 20% of the injured eventually being committed to long term care. This often leads to a downward spiral in physical and mental health. The cost both personally and financially is a tremendous burden to society. Direct cost is between $12-$18 billion a year and indirect cost billions more. (1)

 

 

 Bones are alive and dynamic. Bones consist of a scaffold of elastic tissue on which minerals are deposited to give it its strength for structural support. They are constantly in a state of remodeling. The remodeling does not change the shape of the bone but is intended to repair damage caused by repeated stresses the bone sustains. Bones typically develop small cracks and deformities will occur in areas of cell damage. This creates a constant demand for repair. Remodeling is the process that repairs and replaces these areas of damaged bone.  Remodeling also prevents accumulation of too much old bone, which can lose its resilience and become brittle. Osteoclasts are special cells that breakdown old bone and creates a surface for new bone to be replaced. Osteoblasts are another class of special cells that lay down the new bone in orderly layers that add strength and elasticity to the matrix. This process is regulated by mineral and hormonal balance along with mechanical strain. New bone is created in response to stresses placed on the bone. Gravitational forces along with tension from muscle contraction are the stimulus that causes osteoblasts to create new bone. When the mechanical force of the muscles declines, bone mass and strength also declines.

 

According to the North American Menopause Society, bisphosphonates are considered to be first-line therapy for the treatment of postmenopausal osteoporosis. This gold standard medical approach results in a 6-8% improvement of bone density over 3 years. Unfortunately the bone will be denser but is of inferior quality.  Bisphosphonates are drugs that inhibit osteoclast cells. As a result, bone density is increased secondary to diminished bone breakdown. Such medications have no impact on the osteoblastic rebuilding activity. Therefore the minute cracks and damaged area are not repaired. Over time, the bone becomes more dense and brittle, with little reduction in fracture rate. Once Fosamax is taken up in bone, it takes over 10 years for half of it to decay. ( )

In the four year Fracture Intervention Trial: that was randomized, double-blind, placebo-controlled 4432 patients study, Fosamax did not demonstrate a clinically significant reduction in hip fractures. It has been reported that Fosamax increases bone mineral density, but it also may increase fractures of the foot, pelvis, ankle, and hip.(42)

The efficacy (43) for prevention of non-vertebral fractures has not been

demonstrated.

 

Weight-bearing exercises are widely regarded as the best way to load the bone and prevent osteoporosis. Most women believe that walking will provide enough stimuli to create a protective benefit. However, a study led by Paul M. Mayhew, recently published in The Lancet, reported that the part of the hip bone most likely to fracture does not receive adequate mechanical load by walking. This is especially important because the most common way to fracture the hip is by a sideways fall. So the sense of security of preventing fracture by walking is now being seriously questioned. Another approach is to train elderly individuals with strenuous load-bearing exercises. In elderly individuals, those type of exercises  are not the easiest to perform and may actually increase the risk for injuries.(19) This makes it very difficult to implement a safe method to stimulate appropriate bone remodeling.

Researchers at the University of Cambridge found hip fragility directly related to the incidence of fracture. In particular, fracture rate increases because of decreased mechanical loading of the upper, outer portion of the neck of the hip. This results in that portion of the bone becoming thinner and less capable of withstanding stressful shocks.

 

TurboSonic Whole body Vibration Therapy is a novel way to specifically train the hip musculature in an appropriate non traumatic manor stimulating healthy remodeling.  TurboSonic Whole body Vibration Therapy performed for a period of 6 months utilizing frequencies from 8-11 Hertz has demonstrated a 12% improvement in bone density of the hip measured by DEXA scan. The training requires the individual to stand on a platform that displaces in a perfectly vertical direction, mimicking gravity. The platform moves with varying frequencies and displacements. The patient performs both two-legged and one-leg squats. The platform plate will move with varying displacements which can vary the G force intensity. This evokes reflexive muscle contractions of various intensities which improves strength, balance and synchronizes muscle contractions. There were no reported vibration-related side effects.

It can be inferred from the mechanism of stimulus that this WBV training created a more vibrant and strong hip. The bone has increased its density and elasticity due to both the mechanical stresses transmitted to the bone and also from increased muscle activity of the hip musculature. The thigh muscles were contracted at rates of 480 to 660 times per minute, while bringing the femur musculature from flexion into extension. The Turbosonic Vibration Therapy Trainer allows the therapist to regulate the frequency and intensity of the platform plate’s displacement resulting in a gradual, easily tolerated, but not overtaxing training.

 

The training regimen presented here offers a state-of-the-art, high tech, non-toxic, non-invasive way to stimulate the body’s own natural healing responses to not only heal and restore its own bone mineral density, but also as a way of preventing fractures from occurring in those people who might otherwise be prone to develop the condition.

 

The bone density increase of 12% at 24 weeks of TurboSonic Whole Body Vibration Therapy is greater than the 1.5% gain in (hip) BMD observed with antiresorptive agents at the 6-month time point. (21,22) thus supporting the potential clinical relevance of TurboSonic Vibration Therapy Training.

 

This initial case report suggest that further controlled studies of this novel, high tech, therapeutic method should be performed.

 

References:

1. Kannus P, Parkkari J, Niemi S 1995 Age-adjusted incidence of hip

fractures. Lancet 346:50–51.

2. Autier P, Haentjens P, Bentin J, Baillon JM, Grivegnee AR,

Closon MC, Boonen S 2000 Costs induced by hip fractures: A

prospective controlled study in Belgium. Belgian Hip Fracture

Study Group. Osteoporos Int 11:373–380.

3. Magaziner J, Simonsick EM, Kashner TM, Hebel JR, Kenzora JE

1990 Predictors of functional recovery one year following hospital

discharge for hip fracture: A prospective study. J Gerontol 45:

M101–M107.

4. Gutin B, Kasper MJ 1992 Can vigorous exercise play a role in

osteoporosis prevention? A review. Osteoporos Int 2:55–69.

5. Lanyon LE 1996 Using functional loading to influence bone mass

and architecture: Objectives, mechanisms, and relationship with

estrogen of the mechanically adaptive process in bone. Bone

18(Suppl 1):37S–43S.

6. Rubin C, Turner AS, Muller R, Mittra E, McLeod K, Lin W, Qin

YX 2002 Quantity and quality of trabecular bone in the femur are

enhanced by a strongly anabolic, noninvasive mechanical intervention.

J Bone Miner Res 17:349–357.

7. Flieger J, Karachalios T, Khaldi L, Raptou P, Lyritis G 1998

Mechanical stimulation in the form of vibration prevents postmenopausal

bone loss in ovariectomized rats. Calcif Tissue Int

63:510–514.

8. Delecluse C, Roelants M, Verschueren S 2003 Strength increase

after whole-body vibration compared with resistance training. Med

Sci Sports Exerc 35:1033–1041.

9. Burke D, Schiller HH 1976 Discharge pattern of single motor units

in the tonic vibration reflex of human triceps surae. J Neurol

Neurosurg Psychiatry 39:729–741.

10. Cummings SR, Nevitt MC, Browner WS, Stone K, Fox KM,

Ensrud KE, Cauley J, Black D, Vogt TM 1995 Risk factors for hip

fracture in white women. Study of Osteoporotic Fractures Research

Group. N Engl J Med 332:767–773.

11. American College of Sports Medicine 2000. Exercise prescription.

In: Franklin BA, Whaley MH, Howley ET (eds.) ACSM’s Guidelines

for Exercise Testing and Prescription. Lippincott Williams

and Wilkins, Philadelphia, PA, USA, pp. 138–139.

12. Karvonen M, Kentala K, Mustala O 1957 The effects of training on

heart rate: A longitudinal study. Ann Med Experimentalis et Biologiae

Fenniae 35:307–315.

13. American College of Sports Medicine 1998 American College of

Sports Medicine Position Stand. Exercise and physical activity for

older adults. Med Sci Sports Exerc 30:992–1008.

14. Boonen S, Rosen C, Bouillon R, Sommer A, McKay M, Rosen D,

Adams S, Broos P, Lenaerts J, Raus J, Vanderschueren D, Geusens

P 2002 Musculoskeletal effects of the recombinant human IGF-I/

IGF binding protein-3 complex in osteoporotic patients with proximal

femoral fracture: A double-blind, placebo-controlled pilot

study. J Clin Endocrinol Metab 87:1593–1599.

15. Bouillon R, Vanderschueren D, Van Herck E, Nielsen HK, Bex M,

Heyns W, Van Baelen H 1992 Homologous radioimmunoassay of

human osteocalcin. Clin Chem 38:2055–2060.

16. Rosenquist C, Fledelius C, Christgau S, Pedersen BJ, Bonde M,

Qvist P, Christiansen C 1998 Serum CrossLaps One Step ELISA.

First application of monoclonal antibodies for measurement in

serum of bone-related degradation products from C-terminal telopeptides

of type I collagen. Clin Chem 44:2281–2289.

17. Rubin C, Turner AS, Mallinckrodt C, Jerome C, McLeod K, Bain

S 2002 Mechanical strain, induced noninvasively in the highfrequency

domain, is anabolic to cancellous bone, but not cortical

bone. Bone 30:445–452.

18. Wolff J 1986 The law of bone remodeling. In: Maquet P, Furlong

R (eds.) Bone Remodeling. Springer Verlag, Berlin, Germany.

19. Kallinen M, Markku A 1995 Aging, physical activity and sports

injuries. An overview of common sports injuries in the elderly.

Sports Med 20:41–52.

20. Turner CH, Takano Y, Owan I 1995 Aging changes mechanical

loading thresholds for bone formation in rats. J Bone Miner Res

10:1544–1549.

21. Ettinger B, Black DM, Mitlak BH, Knickerbocker RK, Nickelsen

T, Genant HK, Christiansen C, Delmas PD, Zanchetta JR, Stakkestad

J, Gluer CC, Krueger K, Cohen FJ, Eckert S, Ensrud KE,

Avioli LV, Lips P, Cummings SR 1999 Reduction of vertebral

fracture risk in postmenopausal women with osteoporosis treated

with raloxifene: Results from a 3-year randomized clinical trial.

Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators.

JAMA 282:637–645.

 

22. Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T,

Keller M, Chesnut CH III, Brown J, Eriksen EF, Hoseyni MS,

Axelrod DW, Miller PD 1999 Effects of risedronate treatment on

vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: A randomized controlled trial. Vertebral Efficacy With Risedronate Therapy (VERT) Study Group. JAMA 282:1344–1352.

23. Rubin CT, Lanyon LE 1985 Regulation of bone mass by mechanical strain magnitude. Calcif Tissue Int 37:411–417.

24. Turner CH, Owan I, Takano Y 1995 Mechanotransduction in bone: Role of strain rate. Am J Physiol 269:E438–E442.

25. Frost HM 1990 Skeletal structural adaptations to mechanical usage (SATMU): 1. Redefining Wolff’s law: The bone modeling problem. Anat Rec 226:403–413.

26. Bassey EJ, Littlewood JJ, Taylor SJ 1997 Relations between compressive axial forces in an instrumented massive femoral implant, ground reaction forces, and integrated electromyographs from vastus lateralis during various ’osteogenic’ exercises. J Biomech 30:213–223.

27. Groothausen J, Siemer H, Kemper HCG, Twisk J, Welten DC 1997 Influence of peak strain on lumbar bone mineral density: An

analysis of 15-year physical activity in young males and females.

Pediatr Exerc Sci 9:159–173.

28. Heinonen A, Kannus P, Sievanen H, Oja P, Pasanen M, Rinne M,Uusi-Rasi K, Vuori I 1996 Randomised controlled trial of effect of

high-impact exercise on selected risk factors for osteoporotic fractures. Lancet 348:1343–1347.

29. Rubin CT, Lanyon LE 1987 Kappa Delta Award paper. Osteoregulatory nature of mechanical stimuli: Function as a determinant for adaptive remodeling in bone. J Orthop Res 5:300–310.

30. Qin YX, Rubin CT, McLeod KJ 1998 Nonlinear dependence of

loading intensity and cycle number in the maintenance of bone

mass and morphology. J Orthop Res 16:482–489.

31. Torvinen S, Kannus P, Sievanen H, Jarvinen TA, Pasanen M,

Kontulainen S, Nenonen A, Jarvinen TL, Paakkala T, Jarvinen M,

Vuori I 2003 Effect of 8-month vertical whole body vibration on

bone, muscle performance, and body balance: A randomized controlled study. J Bone Miner Res 18:876–884.

32. Cordo P, Inglis JT, Verschueren S, Collins JJ, Merfeld D, Rosenblum S, Buckley S, Moss F 1996 Noise in human muscle spindles. Nature 383:769–770.

33. Tanaka SM, Alam IM, Turner CH 2003 Stochastic resonance in

osteogenic response to mechanical loading. FASEB J 17:313–314.

34. Tanaka SM, Li J, Duncan RL, Yokota H, Burr DB, Turner CH

2003 Effects of broad frequency vibration on cultured osteoblasts.

J Biomech 36:73–80.

35. Lings S, Leboeuf-Yde C 2000 Whole-body vibration and low back pain: A systematic, critical review of the epidemiological literature 1992–1999. Int Arch Occup Environ Health 73:290–297.

36. Rittweger J, Beller G, Felsenberg D 2000 Acute physiological

effects of exhaustive whole-body vibration exercise in man. Clin

Physiol 20:134–142.

37. Rittweger J, Just K, Kautzsch K, Reeg P, Felsenberg D 2002

Treatment of chronic lower back pain with lumbar extension and

whole-body vibration exercise: A randomized controlled trial.

Spine 27:1829–1834.

38: Dan Med Bull. 2002 Feb;49(1):1-18. Bisphosphonates for prevention of postmenopausal osteoporosis.Ravn P.Center for Clinical and Basic Research, Ballerup Response to Therapy with Once-Weekly Alendronate 70 mg Compared to Once-Weekly Risedronate 35 mg in the Treatment of Postmenopausal Osteoporosis A.I. Sebba et al. Curr Med Res Opin. 2004; 20:2031–2041 J Bone Miner Res. 2006 Sep;21(9):1464-74.

 

39:Low-level, high-frequency mechanical signals enhance musculoskeletal development of young women with low BMD. Gilsanz V, Wren TA, Sanchez M, Dorey F, Judex S, Rubin C.20:41–52 JOURNAL OF BONE AND MINERAL RESEARCHVolume 19, Number 3, 2004 Published online on December 22, 2003; doi: 10.1359/JBMR.0301245

ฉ 2004 American Society for Bone and Mineral Research

 

41. Surgeon General

42 Worst Pills, Best Pills: A Consumer's Guide to Preventing Drug-Induced Death: Books: Sid M. Wolfe by Sid M. Wolfe

 

Patient Education & Monograph

 

 

Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package DA-FOS73(4). 2. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package DA-FOS76

43 http://www.fda.gov/cder/foi/label/2004/20560s043,044,21575s005,006lbl.pdf