A Comparative Effectiveness Study of Bone Density Changes
in Women over 40 Following Three Bone Health Plans
Containing Variations of the Same
Novel Plant-sourced Calcium

This section is compiled by Frank M. Painter, D.C.
Send all comments or additions to:    Frankp@chiro.orgM.font>

FROM:   International Journal of Medical Sciences 2011 (Mar 2);   8 (3):   180–191

Kaats GR, Preuss HG, Croft HA, Keith SC, Keith PL.

Integrative Health Technologies, Inc,
4940 Broadway, San Antonio,
Texas 78209, USA.
grk@ihtglobal.com

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Plant-Sourced Calcium and Vitamin D Supplementation Increases Bone Mineral Density If you are a woman over forty, you may be starting to worry about bone health. Everyone loses bone as they age. By the time a women is told she has osteoporosis, her gradual loss of bone mass has been progressing for years. Men lose bone too, but only about half as fast as women. Medically speaking, osteoporosis is characterized by low bone density and structural deterioration of bone tissue. The soft spongy bone in the wrists, hips, and spine are the most vulnerable to osteoporosis and prone to breakage as a result. Vitamin D is known as the "sunshine" vitamin because it is formed in the body by the action of the sun's ultraviolet rays on the skin. The fat-soluble vitamin is converted in the kidneys to the hormone calcitrol, which is actually the most active form of vitamin D. The effects of this hormone are targeted at the intestines and bones. Decreased vitamin D intake along with not enough sunlight exposure can cause a vitamin D deficiency. Other causes could be inadequate absorption and impaired conversion of vitamin D into its active form. When vitamin D deficiency occurs, bone mineralization is impaired which leads to bone loss. Rickets, osteomalacia, osteoporosis, crohn’s disease and cancer are associated with vitamin D deficiency. A Comparative Effectiveness Research (CER) study was conducted to compare changes in bone mineral density by following one of three bone health plans. Researchers tested 414 women over 40 years of age and 176 of the women agreed to participate in the study and to follow one of the three programs. One Plan contained a bone-health supplement with 1,000 IUs of vitamin D3 and 750 mg of a plant-sourced form of calcium for one year. The other two Plans contained the same plant form of calcium, but with differing amounts of vitamin D3 and other added bone health ingredients along with components designed to increase physical activity and health literacy also for one year. The results were all three treatment groups with above average compliance experienced significantly greater increases in bone mineral density in comparison to the two expected-change reference groups. The group following the most nutritionally comprehensive Plan outperformed the other two groups. These findings suggest increased compliance with the Plans resulted in increased BMD levels. There were no adverse effects in the blood chemistry tests, self-reported quality of life or daily tracking reports. The authors stated “The Plans tested suggest a significant improvement over the traditional calcium and vitamin D3 standard of care.” Thanks to NHI OnDemand.com

The Abstract:

BACKGROUND:   The US Surgeon General's Report on Bone Health suggests America's bone-health is in jeopardy and issued a "call to action" to develop bone-health plans incorporating components of (1) improved nutrition, (2) increased health literacy, and (3) increased physical activity.

OBJECTIVE:   To conduct a Comparative Effectiveness Research (CER) study comparing changes in bone mineral density in healthy women over-40 with above-average compliance when following one of three bone health Plans incorporating the SG's three components.

METHODS:   Using an open-label sequential design, 414 females over 40 years of age were tested, 176 of whom agreed to participate and follow one of three different bone-health programs. One Plan contained a bone-health supplement with 1,000 IUs of vitamin D(3 )and 750 mg of a plant-sourced form of calcium for one year. The other two Plans contained the same plant form of calcium, but with differing amounts of vitamin D(3) and other added bone health ingredients along with components designed to increase physical activity and health literacy. Each group completed the same baseline and ending DXA bone density scans, 43-chemistry blood test panels, and 84-item Quality of Life Inventory (QOL). Changes for all subjects were annualized as percent change in BMD from baseline. Using self-reports of adherence, subjects were rank-ordered and dichotomized as "compliant" or "partially compliant" based on the median rating. Comparisons were also made between the treatment groups and two theoretical age-adjusted expected groups: a non-intervention group and a group derived from a review of previously published studies on non-plant sources of calcium.

RESULTS:   There were no significant differences in baseline BMD between those who volunteered versus those who did not and between those who completed per protocol (PP) and those who were lost to attrition. Among subjects completing per protocol, there were no significant differences between the three groups on baseline measurements of BMD, weight, age, body fat and fat-free mass suggesting that the treatment groups were statistically similar at baseline. In all three treatment groups subjects with above average compliance had significantly greater increases in BMD as compared to the two expected-change reference groups. The group following the most nutritionally comprehensive Plan outperformed the other two groups. For all three groups, there were no statistically significant differences between baseline and ending blood chemistry tests or the QOL self-reports.

CONCLUSIONS:   The increases in BMD found in all three treatment groups in this CER stand in marked contrast to previous studies reporting that interventions with calcium and vitamin D(3) reduce age-related losses of BMD, but do not increase BMD. Increased compliance resulted in increased BMD levels. No adverse effects were found in the blood chemistry tests, self-reported quality of life and daily tracking reports. The Plans tested suggest a significant improvement over the traditional calcium and vitamin D(3) standard of care.

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