A comparative effectiveness study of bone density changes in @entity1 over 40 following three bone health plans containing variations of the same novel plant-sourced XXXX .

@entity1 @entity3875 @entity6661 @entity1555 @entity460
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 @entity1 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 @entity460 for one year. The other two Plans contained the same plant form of @entity460 , but with differing amounts of @entity3875 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 @entity1555 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 @entity460 . RESULTS: There were no significant differences in baseline @entity1555 between those who volunteered versus those who did not and between those who completed per protocol (PP) and those who were lost to @entity6661 . Among subjects completing per protocol, there were no significant differences between the three groups on baseline measurements of @entity1555 , 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 @entity1555 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 @entity1555 found in all three treatment groups in this CER stand in marked contrast to previous studies reporting that interventions with @entity460 and @entity3875 reduce age-related losses of @entity1555 , but do not increase @entity1555 . Increased compliance resulted in increased @entity1555 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 @entity460 and @entity3875 standard of care.
