Supplementation with bio-calcium from shells Pinctada maxima in postmenopausal women with decreased mineral bone density--pilot study.
INTRODUCTION
Treatment of osteoporosis, in addition to a specific antiresorptive or anabolic treatment, requires supplementation with calcium and vitamin D. Widespread cultivation of pearl shells has made pearls available for commercial use for a very reasonable price. The main chemical compound of pearls from shells Pinctada maxima is calcium-carbonate (CaCO3). Recently developed technologies applied in a micronisation process have provided increased gastrointestinal resorption of calcium, estimated at over 90% of calcium intake.


OBJECTIVE
The paper is aimed at monitoring of efficacy and tolerance of six-month bio-calcium supplementation in postmenopausal women with reduced bone mineral density.


METHODS
Group 1 (30 patients) received, three times a day, capsules of pearl powder from shells Pinctada maxima (it is equal to 260 mg of elementary calcium); group II (20 patients) received a daily dose of 500 mg inorganic CaCO3. Both groups received 666 IU of cholecalciferol per day. In all patients, bone mineral density (BMD) of the spine or hip, serum blood and urine levels of Ca, phosphates and alkaline phosphatase, were measured before and after six months of the treatment.


RESULTS
Group I/Group II: average age 61.7/61.7 years; beginning of menopause: 48.32 /48 years; menopause duration 13.4/13.7 years; average body mass index 27.2/27 kg/m2. These two groups did not different significantly before supplementation. Six-month supplementation with CaCO3 of the biological origin led to the increase of BMD from 0.901 g/cm2 to 0.948 g/cm2 (p = 0.067), while BMD remained the same in the group supplemented with inorganic CaCO3 Gastrointestinal tolerability of bio-calcium was excellent, without any adverse events.


CONCLUSION
These data could not strongly support the hypothesis of better efficacy of bio-calcium taking into account a small number of patients and a short follow-up period in this pilot study. Tolerance of CaCO3 of the biological origin was excellent and free of any adverse events. The results of laboratory values were within normal range.