With approximately 77 million Baby Boomers in the U.S. now in the 49 to 67-year-old age range, bone health is becoming a serious consideration. About 52 million Americans have low bone density or osteoporosis, according to the National Osteoporosis Foundation (NOF), Washington, D.C., and one in two women, and up to one in four men over the age of 50, will break a bone as a result of osteoporosis. By 2020, the NOF anticipated that half of all Americans over the age of 50 will have osteoporosis or low bone density.

“Now that Boomers have entered their 50s, bone loss will be a greater concern,” noted Kathy Lund, vice president of business development and marketing for AIDP, City of Industry, CA. In fact, she and many experts see osteoporosis as a major public health threat, as well as a significant financial burden. “Approximately 25% of postmenopausal Caucasian women in the U.S. will develop osteoporosis, posting an estimated cost of $13.8 billion annually.”

These staggering numbers have motivated more consumers to consider their bone health seriously. In an annual Consumer Survey on Dietary Supplements, the Council for Responsible Nutrition (CRN), Washington, D.C., found that 29% of supplement users reported taking them specifically to improve their bone health. While 36% of respondents taking supplements for bone health were over the age of 55, a younger audience is also looking to protect their bones preventively. The survey reported 17% of those taking supplements for bone health were between the ages of 18 and 34, and 31% were between the ages of 35 and 54.

“Osteoporosis typically develops in later life as hormone levels decline. However, the bone building years are during the teen years with peak bone mass accrual occurring in most individuals by the early 20s,” explained Susan Randall MSN, FNP-BC, senior director, science & education, at the NOF. ”During midlife, it is essential to get adequate exercise, calcium and vitamin D in order to maintain bone mass.”

With younger and older people looking to protect their bones, sales for supplements supporting bone health reached $1.8 billion in 2012 on 2.2% growth, according to Nutrition Business Journal estimates. The market is expected to reach $2 billion by 2015.

Calcium: A Bone Health Mainstay
One of the key pillars of maintaining healthy bones is sufficient calcium consumption. A mainstay of bone health ingredients, calcium is the most plentiful mineral found in the body.

“Calcium is the fifth most abundant element in the Earth’s crust and the average adult body consists of between 1,000 and 1,500 grams of calcium, with the majority being localized in teeth and bones,” explained Patrick Stano, vice president of sales & marketing, North America, Dr. Paul Lohmann Inc., Islandia, NY.

However, humans do not naturally produce calcium, so it must be absorbed through foods and supplements. Foods that naturally contain calcium include dairy such as cheese, milk and yogurt; dark leafy green vegetables such as bok choy, kale and broccoli; and nuts such as almonds. Yet, few people eat enough of these foods to get the calcium needed to protect bones properly. As a result, calcium fortified functional foods and beverages like juices, breads, cereals, soy drinks and tofu have also become an increasingly popular option for those looking to include calcium as part of their daily routine.

Recent research has come to question whether calcium supplementation may have negative effects on cardiovascular health, and if such a threat is worth the risk in an attempt to prevent osteoporosis. In 2013, a study published in JAMA Internal Medicine suggested that a high intake of supplemental calcium may be associated with an increased risk of cardiovascular disease deaths among men, while a study in the British Medical Journal found high calcium intake in women was associated with higher risk of death from all causes—especially cardiovascular disease. In light of this research, the U.S. Preventive Services Task Force advised against the use of calcium in postmenopausal women.

Following the release of these studies, trade organizations like CRN and the Natural Products Association (NPA) questioned the methods of both trials, citing design defects in the studies and inconclusive results. Both organizations (as well as the JAMA study itself) suggested that larger studies were needed to assess the potential risks vs. benefits of calcium supplementation.

Despite the recent calcium controversy, continued demand for the supplement has led to new innovation and formulation.

“Different forms of calcium continue to be an area of new ingredient growth within the bone health market,” said Nena Dockery, technical services manager for Stratum Nutrition/ESM Technologies, St. Charles, MO.  “Calcium compounds are often susceptible to heavy metal contamination, especially the more natural forms mined from the ground or harvested from the sea. These natural sources of calcium, predominantly in the form of calcium carbonate, have the advantage of containing higher amounts of elemental calcium (35-40%) than those forms prepared in the lab (calcium citrate, calcium lactate or calcium maleate), which contain at most around 24% calcium. But the risk of heavy metal contamination and potential issues with digestibility sometimes limit their desirability.”

Ms. Dockery noted that eggshell calcium has emerged as a natural option for calcium supplements. “Derived from chicken eggshells, this type of calcium contains around 37% elemental calcium, does not pose a heavy metal risk, is highly absorbable and doesn’t cause the common digestive complaints or side effects typically associated with other natural calcium forms.”

Supporting Absorption: Vitamin D & Magnesium
Calcium consumption alone isn’t enough to support healthy bones. According to Vladimir Badmaev, MD, PhD, head of R&D at NattoPharma ASA, Oslo, Norway,  “The effects of vitamin D and calcium cannot be separated. Calcium and vitamin D supplementation are historically one of the most researched and sound nutritional combinations to strengthen bone structure in infants, children, women, men and diverse racial or ethnic groups.”

Citing a 2010 position statement of The North American Menopause Society, Dr. Badmaev advised that adequate calcium and vitamin D intake along with lifestyle factors like a balanced diet and adequate exercise “are the most important measures to maintain bone health and prevent osteoporosis.”

Mr. Stano of Dr. Paul Lohmann also stressed the importance of vitamin D in the absorption of calcium, stating, “supplements and food products should utilize a combination of a highly bioavailable calcium salt in conjunction with vitamin D,” in order to get the best possible results for bone health.

Stratum’s Ms. Dockery explained that vitamin D works to promote calcium absorption through the intestinal wall and maintains serum calcium and phosphate levels in the body. “This function is critical for normal bone mineralization,” she said. 

Magnesium also plays a key role in supporting bone health. “Magnesium helps regulate bone homeostasis through its role in maintaining concentrations of parathyroid hormone and the active form of vitamin D,” said Ms. Dockery. “Together, vitamin D and magnesium help ensure that bones remain healthy through an optimal balance between the building of new bone and the breakdown and resorption of old bone.”

Because calcium, vitamin D and magnesium support one another in maintaining bone mass, many supplements today combine the three “to ensure the body’s proper absorption and utilization of calcium for healthy bone growth and remodeling,” explained Ms. Dockery.

Vitamin K: The ‘Forgotten Vitamin’
Research has found that vitamin K, specifically vitamin K2 long-chain menaquinone-7 (MK-7), plays a key role in the nutritional support of healthy skeletal and cardiovascular systems.

NattoPharma’s Dr. Badmaev described vitamin K2 as a “chaperone,” which directs dietary calcium to strengthen bone structure and prevent arterial deposition of calcium, or arterial calcification. As calcium’s chaperone, vitamin K2 provides a critical service in “modifying multiple physiological functions of calcium underlying age-related deterioration of bone, as well as cardiovascular and metabolic health.”

While critical to bone health, Dr. Badmaev explained vitamin K2 is often “a forgotten vitamin,” as vitamin K1 is more readily available in the typical Western diet. “The major dietary form of vitamin K has been considered to be K1, whose most abundant source is green and leafy vegetables. Meanwhile, vitamin K2 is found in “animal products, meat, dairy, eggs and fermented food (e.g., cheese, yogurt and natto, the Japanese traditional food).”

Natto—a fermented soybean dish widely consumed as breakfast food in Japan—is perhaps the most recognized vitamin K2 rich food available. According to Dr. Badmaev, “epidemiological findings suggest it is vitamin K2 (predominantly MK-7), but not K1, that directs dietary calcium to strengthen the bone structure and prevent arterial deposition of calcium or arterial calcification.”

Moreover, current research has found that most healthy adults may actually be sub-clinically deficient in K2, “which results in K2-dependent proteins being biologically inactive in regulating calcium placement and utilization in the body,” Dr. Badmaev said.

NattoPharma’s vitamin K2 supplement, MenaQ7, was recently assessed in a clinical study published in Osteoporosis International.

The randomized, double-blind, placebo-controlled clinical trial evaluated the results of three-years of regular intake of natural menaquinone-7 (MenaQ7) at 180 mcg daily in a group of 244 healthy post-menopausal Dutch women, ages 55 to 65. The subjects were randomly assigned to receive either MenaQ7 or placebo capsules daily. Results showed that supplementation of K2—especially menaquinone-7—for one year or longer, improved bone mineral density, bone mineral concentration and bone strength (Knapen et al., 2013, Osteoporosis International).

“With new research and technology of vitamin K2 (i.e., MenaQ7 Crystals) showing preservation of bone health and improvement in arterial elasticity in healthy women, the market is poised to explode,” said Eric Anderson, global vice president of marketing for NattoPharma. While the global natural vitamin K2 market is still relatively new, Mr. Anderson cited a strong market growth rate of 20% per year. 

Bone Flexibility: Collagen
While supplemental calcium, vitamin D, magnesium and vitamin K all focus on addressing bone density, some ingredients, such as collagen, take a different approach. “Traditional calcium supplements for bone health focus on bone mineral density without improving bone flexibility. In fact, too much calcium can have adverse effects,” said Ms. Lund of AIDP. The company’s molecularly-bonded combination of calcium and collagen, KoACT, is a patented collagen designed to improve density and flexibility, thus creating stronger bones.

Seventy-five percent of dry bone mass consists of inorganic minerals, mostly calcium, while the other 25% is an organic matrix made mostly of bone collagen. “Calcium builds bone density, but collagen builds the framework for calcium to attach to,” Ms. Lund explained. “Using a skyscraper as an analogy, collagen is the steel frame, while calcium is the cement. Collagen is essential to improving bone flexibility, which helps bones absorb impact. Without it, even the strongest bones can crack, shatter or break, and running, jumping and other activities become painful.”

She added that although the body produces collagen naturally, its abundance decreases with age.

In supporting KoACT’s efficacy, a human clinical study was conducted at Florida State University in which 40 postmenopausal women were recruited and randomly assigned to one of the two treatment groups: calcium or KoACT. Assessment of the women was conducted at baseline, three and six months, and bone mineral density (BMD) and biochemical markers of bone metabolism were measured at the start of the study, at 6 months and after 12 months of supplementation.

Results indicated subjects using KoACT had significantly improved bone synthesis biomarkers, as well as decreased BMD loss as compared to calcium users after one year of intake. Researchers concluded that KoACT benefits bone health by both increasing bone synthesis and also reducing bone resorption, shifting the bone metabolism to a more youthful level.

“Interestingly,” said Ms. Lund, “KoACT also seems to suppress sclerostin levels. An antibody to sclerostin is currently the hottest osteoporosis drug being developed. These bone biomarker changes observed in this double-blind, placebo-controlled study suggest KoACT, a natural nutraceutical product, seems to bring all desirable characteristics to bone health management.”

Support from Soy
Genistein, the principal isoflavone found in soybeans and soy foods, has also been associated with bone health. Todd Sitkowski, senior marketing manager with DSM Nutritional Products, Parsippany, NJ, described the critical role of soy isoflavones in the bone remodeling process that takes place in menopausal and postmenopausal women as their estrogen levels drop, leaving them vulnerable to weakened bones.

“As the consumption of soy foods is low in most western countries, a dietary supplement containing genistein provides a useful option for improving bone mineral density,” he said. “geniVida is DSM’s proprietary pure genistein, produced by a patented process that is soy-free and is supported by a comprehensive safety package.”

DSM’s senior scientific leader, Deshanie Rai, PhD, FACN, pointed to a growing body of clinical research that indicated genistein is an important tool in protecting the bones of postmenopausal women. “These studies show a specific benefit of genistein on limiting bone mineral loss in the lumbar spine, femoral neck and ward’s triangle region.”

Emerging Demographics
With so many Baby Boomers affected by osteoporosis and weakened bones as a result of aging, awareness surrounding bone health has grown, perhaps influencing a younger audience focused on prevention.

Rather than try to treat the issue in old age, more people today are realizing healthy bones begin with proper nutrition in childhood. “The blueprint for strong bones really begins early in life and essential nutrients play a vital role in guiding the development of bone over the years,” said DSM’s Mr. Sitkowski. “Pediatric Associations recommend infants and children consume vitamin D from birth through adolescence to make sure nutritional needs are met.  Vitamin D deficiency in children and adolescents is now a widely recognized public health problem worldwide and it is thanks to this growing awareness that many companies are starting to market their bone health solutions to younger demographics.”

If optimal bone mass can be reached by the late 20s, the body has a better chance of weathering the natural amount of bone degradation that occurs with age. With a healthy diet and regular exercise, children and adolescents can prepare their bones for a healthy future. “However, in the U.S. and globally today, many children and teenagers spend much of their spare time in sedentary activities,” noted Ms. Dockery of Stratum, “and often their diets consist predominantly of processed and convenience foods. Of those young people with less than ideal bone-building lifestyles, a well-designed bone support supplement can make a huge difference in the future health of their skeletal system.”

She added, “A good bone support supplement can also be beneficial for those in their 30s and 40s as a way of maintaining healthy bone density and for some to help compensate for poor dietary and exercise habits.”

Taylor C. Wallace, PhD, CFS, FACN, senior director of science policy and government relations at NOF, pointed out that economic and social factors can correlate with how well we preserve our bones. “A new study shows that many Americans, particularly those who are low-income, minority populations and those who are overweight and/or obese do not achieve adequate amounts of calcium and vitamin D from food alone. For those who do not meet the intake recommendations for calcium and vitamin D, NOF recommends supplementing to fill the gap.”

AIDP’s Ms. Lund said bone health supplements offer new opportunities in the sports nutrition arena—particularly among female athletes and exercise enthusiasts. While typically a male audience is targeted with sports supplements, the growing number of female athletes suggests potential for a big opportunity. In fact, according to the Sporting Goods Manufacturing Association, the number of women working out is equal to or greater than men.

“There has been a surge in women’s lifestyle sports including yoga, triathlons and weight lifting,” stated Ms. Lund. “Yoga is now over a $6.5 billion industry with recession-busting growth rates of 9.5%. Over 40% of triathlon participants were women. The average age of a triathlete is over 40, highly educated and in the upper income levels. The sports supplement industry is passing women by.”

New Formulations for Bone Health
Appealing to the broad range of consumers looking to preserve their bones calls for a wide variety of delivery options.
For those with more serious bone density issues, support from a physician may be in order. Seeing this need, NattoPharma developed a vitamin K2-based medical food, which the company’s Mr. Anderson described as evolving “from a growing need for the specific dietary management of a disease or a health condition with a specifically formulated food.”

Prescribed under the supervision of a healthcare practitioner, the formulation of NattoPharma’s medical food is based on recognized scientific principles, including preclinical and clinical studies as developed by the company. NattoPharma also formulated a 100% water-soluble (non-dispersible) vitamin MK-7 with a minimum of 16 months stability in a beverage.

More conventional bone supplements can benefit from new delivery experiences, such as soft chews or gummies. “Chews can accommodate more active ingredients per chew, thus lowering the dosage. Taste can be a challenging factor, however,” said Stratum’s Ms. Dockery.

Lana Woshnak, regional technical marketing manager for dietary supplements, DSM Nutritional Products, said, “the bone health category seems to extend into joint health for some of the supplement manufacturers. The trend toward gummies seems to apply to this category as well, with bone health gummies targeted primarily for women and kids (with vitamin D and calcium as the primary ingredients).”

Ms. Dockery added that beverages fortified with calcium continue to hold their ground within the functional food and beverage landscape. “Of course milk and other dairy formats have traditionally been the food source for calcium, but now foods such as orange juice and even cereal often have been fortified with calcium and vitamin D as well.”