A Randomized Open-Label Clinical Study Comparing the Efficacy, Safety, and Bioavailability of Calcium Lysinate with Calcium Carbonate and Calcium Citrate Malate in Osteopenia Patients.

Abstract

Introduction:Many factors influence bone health, but osteoporosis is viewed as a calcium deficiency disorder in which bone is resorbed to maintain the serum calcium levels. Dietary calcium supplements have been recommended for the prevention of osteoporosis in the elderly. Many forms of dietary calcium supplements are widely available in market, but products containing calcium citrate and calcium carbonate are the most common. Calcium lysinate, a new form of calcium preparation, may have a better absorption and can be a better calcium supplement.Aim:The aim of this study is to evaluate the efficacy, safety, and bioavailability of calcium lysinate in comparison to other calcium supplements in improving the bone mineral density (BMD) status in osteopenia patients.Methodology:A total of 24 osteopenia patients were randomly divided into three groups of eight subjects in each. Anyone of the study drug, namely, calcium lysinate, calcium carbonate, or calcium citrate malate was administered to each group. Blood samples for the determination of serum calcium was taken, based on which the area under the curve (absorption profile) and relative bioavailability were calculated. BMD was assessed on the day 0 and at 8 weeks’ post-treatment.Results:The relative oral bioavailability of calcium lysinate was 223.15%. There is a significant improvement in the T-score of BMD in all the groups. It was more significant in calcium lysinate group (P < 0.0004).Conclusion:The high oral bioavailability of calcium lysinate, high percentage of calcium content, and a good clinical improvement in the BMD T-scores of osteopenia patients suggest that calcium lysinate will serve as a better dietary calcium supplement.