Osteoporosis has been described as a silent killer, and recent data from the National Osteoporosis Foundation showed that approximately 9 million American adults currently have osteoporosis and another 48 million have low bone mass, placing them at increased risk.
An economic report from Frost & Sullivan and commissioned by the Council for Responsible Nutrition (CRN) recently found that supplements of calcium plus vitamin D for all US women with osteoporosis could provide healthcare cost savings of $1.08 billion per year.
Despite the clear benefits of calcium (and vitamin D) for bone health, papers published in journals such as JAMA, Heart, and the British Medical Journal found significant adverse cardiovascular effects related to excessive calcium intake in different populations, leading to concerns, and even condemnation of calcium supplements by some.
The plaques that form in diseased arteries are composed mostly of calcium, and some researchers have postulated that this is directly related to the rapid spiking of blood calcium levels following ingestion of the supplement.
Sales slump
The literature, however, is contradictory, with data published in the American Journal of Clinical Nutrition and a meta-analysis published in the Journal of Bone and Mineral Research concluding that current evidence does not support the notion that calcium supplements increase the risk of heart disease in elderly women.
Sales of calcium supplements have been affected by the controversy. Our 2012 article reported that calcium sales slumped 3.5%, according to SPINS, against a backdrops of an 8.1% growth in the dietary supplements market as a whole.
Waitaki’s new ingredient, called StimuCal (hydroxyapatite), has been carefully formulated to produce lower peak blood calcium levels than either calcium carbonate or calcium citrate while maintaining an identical effect on markers of bone turn-over.
The ingredient is supported by data from a randomized, placebo controlled trial of 97 postmenopausal women conducted by the Department of Medicine at the University of Auckland, New Zealand (including some of the same researchers who have previously reported a potential link between calcium and adverse heart health effects).
The data was presented at the 2013 meeting of the International Bone and Mineral Society, and a manuscript is currently being prepared for submission to a peer-review journal, said Craig McIntosh, Chief Executive Officer, Waitaki Biosciences.
Study details
The women were randomized to receive 1000 mg per day of calcium as either StimuCal, calcium carbonate, calcium citrate, or placebo. Results indicated that peak blood calcium levels after ingestion of StimuCal were 45-49% lower than peak blood calcium levels after ingestion of the same amount of calcium from either calcium carbonate or calcium citrate.
“After a significant product development phase, and successful clinical trial work, we are delighted to now be in a position to offer this product to the market and look forward to meeting with manufacturers at Supply Side West,” said McIntosh.
The ingredient is currently only available for use in dietary supplements, he added, and the company has not applied for GRAS status for the product. “It is manufactured from certified food grade ingredients and exported to the USA on a human food grade health certificate,” added McIntosh.
The product is insoluble in water, so best suited to hard capsule fill or tableting, he added.