Novel Osteopenic Bone Treatment Lands 4th Patent

The U.S. Patent and Trade Office (PTSO) just granted a 4th patent for an osteopenic bone treatment that, perhaps, is not as well-known nor fully appreciated within the broader musculoskeletal community.

The new patent is # US20210052407A1. Here’s a link if you want to read it yourself.

It is a continuation of another U.S. patent (issued in 2015), which was itself a continuation of another U.S. patent (issued in 2013) which, naturally, was also a continuation of another U.S. patent (issued in 2012).

All of this intellectual property rests on a simple, intriguing scientific principle—that stimulating and loading bone—repeatedly—will make that bone (osteopenic bone, for example) denser, stronger … while also inhibiting fat deposits (adipogenesis).

Low bone mineral density (BMD) is a significant problem. Especially among the elderly—who endure about 1.5 million bone fractures annually.

Bisphosphonates, a class of compounds that is often used to treat low bone mineral density, work well, but the side effects include osteonecrosis of the jaw, erosion of the esophagus, and atypical femoral fractures.

Shake, Rattle and Roll

This 4th patent was issued to Redwood City, California-based Bone Health Technologies, Inc. that, incidentally, also owns the three earlier patents.

Before Bone Health Technologies was founded, scientists tested the effects of repeated mechanical loading on bone tissue using relatively high frequencies (e.g. 15-90 Hz) and relatively low mechanical loads (e.g., 0.1-1.5 g’s).

Repeated loading, they documented, (they called it Whole Body Vibrations or WBV) could delay and/or halt the progression of osteoporosis (Rubin et. al., Journal of Bone and Mineral Research, 19:343-351, 2004).

In another randomized study, scientists documented that ≥0.6 g’s of vibratory force delivered to the feet of patients improved bone mineral density at a statistically significant rate compared to control. (Verschueren et al., Journal of Bone and Mineral Research, 19:352-359, 2004).

And the studies kept piling up.

• WBV improved hip and preserve spine bone mineral densities among healthy cyclists, postmenopausal women, and disabled children (Am J Phys Med Rehabil 2010; 89:997-1009, Ann Intern Med 2011; 155:668-679, J Bone and Mineral Research 2011; 26(8):1759-1766).
• Shear stress within bone marrow in trabecular architecture during high frequency vibration could provide the mechanical signal to marrow cells that leads to bone anabolism (Journal of Biomechanics 45(2012):2222-2229).
• Shear stress above 0.5 Pa is mechanostimulatory to osteoblasts, osteoclasts, and mesenchymal stem cells (Journal of Biomechanics 45(2012):2222-2229).

The first attempts at a product to treat osteopenic patients were vibrating platforms. Patients would stand on them and thereby receive repeated mechanical loading up from the feet to the rest of the body. Sounds like fun, right?

Anyway, the products (e.g., Galileo 900/2000™, Novotec Medical, Pforzheim, Germany; or Power Plate™, Amsterdam, The Netherlands) worked to a degree, but patients had to stand on them for 30 minutes or so and shaking up the feet first really was not efficient. Up to 40% of vibration power was absorbed or dampened by the ankles and knees before reaching hips and spine. (Rubin et al., Spine (Phila Pa. 1976), 28:2621-2627, 2003).

Site Specific Good Vibrations

Bone Health’s family of patents teach how to build a site-specific method to load and vibrate bone. Their devices deliver vibration force directly to the hip, spine, or wherever required—effectively localizing repeated mechanical loads.

In addition, the patents teach how to directionalize the vibrations and bone loading.

Bone Health’s wearable vibration and loading delivery systems make this treatment available to millions of patients with osteopenic bone or who engage in activities which could reduce bone mineral density.

Worth noting, importantly, is that these wave forms have demonstrated an ability to suppress adiposity (PNAS. Nov. 6, 2007; 104(45):17879-17884)—which is to say, reduce stem cell adipogenesis and act as a “nonpharmacologic prevention of obesity and its sequelae” (PNAS. Nov. 6, 2007; 104(45):17879-17884).

There is actually a study which documented the effects of these wave forms on obese women where, in the words of the research team, they displayed a “positive effect on body weight and waist circumference reduction” (Korena J Fam Med. 2011; 32:399-405).

Bone Health Technologies, Inc.

OTW talked with the CEO of Bone Health Technologies (BHT) and asked her about these patents and the ways in which she hopes to “shake things up” for osteopenic patients and their doctors.

“Over 63 million Americans have low bone density, yet the field has been lacking new therapies with no new agents in clinical trials—innovations such as Osteoboost are critical to turning around the public health trajectory of fractures,” said Bone Health Technologies CEO Laura Yecies.

“Osteoboost” by the way, is the brand name of Bone Health’s lead product.

“Vibrations mimic the force of high-impact exercise such as jumping on the skeleton—similar to that exercise the vibration has an anabolic effect stimulating the osteoblasts to create new bone cells and lessening the osteoclast (bone removing) cell activity,” Yecies explained to OTW.

The founder of Bone Health Technologies, Dr. Shane Mangrum, told OTW, “My motivation to invent a novel solution for low bone density resulted directly from my experience treating so many patients with painful vertebral compression fractures. I was determined to develop a non-drug treatment that patients would be interested in using and could incorporate into their daily lives to prevent the loss of bone that results in fractures.”

A Connection to NASA

Like so many other groundbreaking technologies, these wave form inventions have their roots at NASA. “The original research on using whole body vibration to improve bone density and strength was funded by NASA as astronauts lose bone density when in space (since their bones do not get normal weight bearing stimulation in zero gravity),” explained Yecies, “That research found that whole body vibration improved bone density but outside of the astronaut group compliance was a challenge.”

“There are no approved therapies for post-menopausal women with osteopenia. Walking, swimming, and biking are not enough stimulation to the bones, yet the typical older woman cannot or will not do high-impact exercise (and certainly not daily). Without a safe and effective intervention these women are left to lose bone risking their health and lifespan. Osteoboost uniquely is a safe and clinically proven intervention to improve bone strength.”

Now with patent #4 and the ever-increasing body of literature supporting this non-invasive, conservative treatment for low bone mineral density, perhaps it is time to take a much closer look at repeated bone loading using a site-specific approach championed by Bone Health Technologies of Redmond City, California. Here’s a link to the company’s website.