A Randomized, Open Label, Parallel Group Clinical Study Comparing the Relative Bioavailability, Safety and Efficacy of Microcore Nesc® With Calcium Carbonate and Calcium Citrate Malate in Osteopenic and Osteoporotic Patients

Abstract Background Osteoporosis is a skeletal disease characterized by loss of bone mass, reduced bone strength and increased bone fragility predisposing to fractures. Objectives To study the efficacy, safety and relative bioavailability of Microcore NESC® (Natural Egg Shell Calcium) in osteopenia and Osteoporotic patients. Methods This was a Randomized, Open label, parallel group interventional clinical trial which included 60 study participants with osteopenia and osteoporosis who were randomized into 3 groups (20 each). Group 1 - Microcore NESC®, Group 2- Shelcal and Group 3- CCM with 12 weeks treatment period. The participants were evaluated for relative oral bioavailability, Bone mineral density (BMD), Serum Osteocalcin, change in VAS pain scale and quality of life- Questionnaires. Results There was significant improvement in the BMD T scores- post treatment with MICROCORE NESC® and shelcal. Higher percentage of improvement in calcium absorption as depicted by an increase in serum calcium levels (10.23%) in the MICROCORE NESC® treated group when compared to Shelcal (7.7%) and CCM (7.2%). The relative bio availability of MICROCORE NESC® with respect to shelcal was 93%. Discussion MICROCORE NESC®, has shown a better oral relative bio availability of calcium (93%), better improvement of BMD T score compared to Shelcal and CCM. The general health status has improved to very good/ excellent in 83% of patients in MICROCORE NESC® treated group. Conclusion MICROCORE NESC® can be considered a better and safe calcium supplement, as there are very few side effects observed without any clinically significant abnormalities in lab parameters.