Juvent Medical Vibration Machine

Below is some information I received from Dr. Clinton Rubin about a vibration machine he has been developing as a result of his years of research on bone growth. I thought it might be interesting information to some of the rest of you as well:

I have attached, below, a generic "letter" that I send to people interested in the status of our research, and where our science is relative to translating it to the clinic. Also attached are a series of papers, some preclinical (animal), and some clinical (human trials), which report some of the findings we have uncovered thus far. Please be advised that the device described below, manufactured by Juvent, Inc., is not yet approved for use against osteoporosis in the US, but is approved to prevent/reverse the disease in approximately 30 countries around the world. That said, please also recognize that I am a co-founder of the company, and thus have a potential conflict of interest in providing my perspective of what I think the intervention can and cannot do. I am a big believer in the science and technology, and would welcome any additional questions you - or your physician - might have.
Thanks again for your interest in our work.
Best regards,
Clinton Rubin


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Thank you for your inquiry about our basic, applied, and clinical research using low-level mechanical signals as a non-invasive, non-pharmacological intervention to control osteoporosis. This preclinical (animal) work was most visibly referenced in our paper published in the journal Nature (August 9, 2001; 412:603-604; see attached copy which must be opened using Adobe Acrobat). In addition to an increase of more than 30% of trabecular (spongy) bone density in the femur (thigh bone), we were able to show that the trabecular bone in the stimulated animals was 12% stiffer, and 27% stronger, than controls, indicating that the stimulus not only improves the quantity of bone, but the quality of bone. An editorial by J. Eisman, on the potential of this intervention, given the other possible pharmaceutical treatments for osteoporosis already available, can be found in the Lancet (December 8, 2001; 358:1924-1925; attached). A more comprehensive list of publications, reporting work on this topic over the past 20 years, can be found on my web-page, reached via: http://bme.sunysb.edu/bme/people/faculty/c_rubin.html

We have now completed several clinical trials, including studies on post-menopausal women, children with disabling conditions (e.g., cerebral palsy), and young women (16-21years of age) with osteoporosis, each reporting a different aspect of the potential of this non-drug, non-invasive signal to curb and even reverse osteoporosis.

This "preclinical", or animal work has led us to human studies. We have now completed several clinical trials, including studies on post-menopausal women, children with disabling conditions (e.g., cerebral palsy), and young women (16-21years of age) with osteoporosis, each reporting a different aspect of the potential of this non-drug, non-invasive signal to curb and even reverse osteoporosis.

The first study, performed in collaboration with R. Recker and D. Raab-Cullen at Creighton University's Osteoporosis Center, studied sixty-two healthy women, 3-8 years past the menopause, who were randomized into in a double-blind, placebo controlled pilot study. 32 women underwent mechanical loading of the lower appendicular and axial skeleton for two ten-minute periods per day, through floor mounted devices that produced a 0.2g mechanical stimulus at 30Hz (TX). 32 women received placebo devices (PL) and underwent daily treatment for the same period of time. Evaluating those in the highest quartile of compliance (86% compliant), PL lost 2.13% in the femoral neck over the year, while TX was associated with a gain of 0.04%, reflecting a 2.17% relative benefit of treatment (p=0.06). Considering the interdependence of weight, the spine of lighter women (< 65 Kg) who were in the highest quartile of compliance exhibited a relative benefit of TX of 3.35% greater BMD over the year (p=0.009); and for the mean compliance group a 2.73% relative benefit in BMD was measured (p=0.02).

The second, performed in collaboration with K. Ward, J. Adams and Z. Mughal at the University of Manchester, UK, examined twenty children with cerebral palsy (4-19y), who were randomized into treatment (0.3g, 90Hz, ten minutes per day) and placebo groups. Following 6-months, the volumetric trabecular bone mineral density of the tibiae in the placebo group lost 11.9% of BMD in the proximal tibia, while the treatment group gained 6.3%, representing a 17.7% “benefit” of treatment (p=0.0033).

The third study, performed in collaboration with Dr. V. Gilsanz at the Childrens Hospital of Los Angeles, investigated the potential of this intervention to stimulate bone gain in young women w/ osteoporosis. Using CT, these young women, 16-20y of age, showed a 4% increase in trabecular density of the spine and 3% cross sectional area of the femur, as well as approximately 5% increases in muscle mass of the thigh and lower back, highly significant increases as compared to the controls which showed no significant change from baseline.

Please also note that our work has brought us to this point following several decades of searching for the mechanical signal to which bone is responsive. I must emphasize that although our intervention is considered safe and beneficial, other frequencies and amplitudes may cause damage to bone and connective tissues, and many amplitudes of vibration are considered pathogenic to the musculoskeletal (e.g., vertebral disc, cartilage, ligament, tendon), neurovestibular, and cardiovascular systems. Please also remember, as we have determined in our research activities, that the amplitude (magnitude) and duration (dose) of the signal are important parameters which must be tightly controlled. Our device provides a strong anabolic stimulus. However, one should always be concerned that “too much of a good thing” may be true in mechanical stimulation, as well. Just because one aspirin is good for you, doesn't mean that you should take 50 aspirin per day.

We are now working with Juvent, Inc., a new (December 2003) medical device company to develop the technology further. Juvent has obtained a CE mark for marketing the device in Europe with a medical claim for the prevention and treatment of osteoporosis. They are collaborating with Professor D. Kiel, at Hebrew Rehab Center for the Aged, in a larger study on the elderly, funded by the National Institutes of Health. Juvent's contact information is:

Juvent Medical, Inc.
300 Atrium Drive
Somerset, NJ 08873
phone: 732-748-8866
www.juvent.com

In working closely with Juvent, we can finally bring our benchtop work to the bedside… the dream of any biomedical scientist. However, please note that until there is FDA approval, Juvent will NOT make any medical claims in the US, and if you consider using this device, you should consult with your family and physician, and review the available data, to see if such an approach is right for you. If you would like to be kept abreast of the progress of the study, your best contact at Juvent is Mr. Roger Talish, VP for Research and Development, who has worked closely with us on this research for many years. His e-mail address is: rjtalish@juvent.com

Please understand, I am not trying to advocate for the intervention, nor am I in any way trying to endorse Juvent. Until our Phase III study is completed and a label approved by the FDA I would emphasize great caution in considering any device - mechanical or otherwise - which "claims" to have a beneficial influence on bone, in lieu of FDA approved treatments shown to be effective in osteoporosis.

The underlying principle of our theory is that bone is very sensitive to mechanical stimulus. Bone adapts its structure to become denser and stronger or weaker depending on functional demands. As an example, a professional tennis player’s serving arm may have 35% more bone density than the other arm. Conversely, extended bedrest, cast immobilization, or the lack of gravitational loading during space flight leads to substantial bone loss and muscle weakness. Indeed, we are working with NASA now, to determine if this low-level mechanical signal can serve as a countermeasure for osteoporosis in long-term space flight.

As you may know, osteoporosis and other conditions that lead to bone loss are most often thought of as biochemical processes, which result in structurally related symptoms. However, more and more scientists are beginning to appreciate the strong regulatory influence of mechanical forces on bone, and our studies have shown that the application of small strains, through low level vibration, may effectively inhibit or even reverse the effects of these diseases. Typically, exercise such as walking and jogging occur at low frequency with high loading compared to the vibrations that our device employs, but exercise is certainly recognized as key to achieving and maintaining a healthy skeleton. But then, think about the vibrations that muscle, during contraction, bombards the skeleton with through the day. While the signals may not be large, they are omnipresent. We hope (or rather hypothesize!) that the low level vibrations are a key regulatory signal in exercise, and that through low-level vibration we may get the benefit of mechanical loading without requiring that someone run a marathon each day.

I am very hopeful that within a few years’ time treatments using this dynamic motion therapy will be available. I fully support the National Osteoporosis Foundation’s recommendations for the management of bone loss, and certainly make sure that you exercise and have sufficient calcium in your diet. You can find more information about their recommendations on their web site, http://www.nof.org .

Please note that our research has no relationship whatsoever with the technology or claims made by vibration plates used for exercise and physical training and manufactured by companies such as Galaxy, Galileo, Power-Plate, NEMES, etc. The magnitudes used in those devices, well in excess of 8.0g, are well beyond the limits recommended for human tolerance by ISO and OSHA, are 35 times greater in amplitude than those mechanical signals that we study, are perhaps dangerous, and to my knowledge, there is little if any evidence that their devices do anything good to bone. These devices are DANGEROUS, and the consequences of use have never been studied in any form.

Thank you again for your interest in our work. It has been very gratifying to hear from many people who are interested in our studies on the musculoskeletal system. Finally, I am grateful to the National Institutes of Health (NIAMS & NIGMS), the National Aeronautics and Space Administration (NASA), the National Space Biomedical Research Institute (NSBRI), and the US Army for their support of this work. If there is any additional information which I might provide, or if you would like a reprint of the article or any of the follow-on work, please let me know.

Sincerely:
Clinton Rubin