Comparative Evaluation of Bioavailability, Efficacy and Safety of MICROCORE NESC ® with Calcium Carbonate and Calcium Citrate Malate in Osteopenic and Osteoporotic Patients: A Randomized Clinical Trial.

Autor: Gopal K; Department of Orthopaedics, Mahatma Gandhi Medical College and Research Institute, Puducherry, India., Deb B; Integrative Medicine, Medical Affairs, Ki3 Private Limited, Chennai, Tamil Nadu, India., Uma N; Department of Pharmacology, Mahatma Gandhi Medical College and Research Institute, Puducherry, India., Balan S; Department of Pharmacology, Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur, Puducherry, India., GayathriSivakumar; Microcore Research Labs India Pvt Ltd, Erode, Tamil Nadu, India., Chandra Mohan M; Microcore Research Labs India Pvt Ltd, Erode, Tamil Nadu, India., Rajendran P; Microcore Research Labs India Pvt Ltd, Erode, Tamil Nadu, India.
Jazyk: angličtina
Zdroj: Indian journal of orthopaedics [Indian J Orthop] 2024 Mar 06; Vol. 58 (5), pp. 535-541. Date of Electronic Publication: 2024 Mar 06 (Print Publication: 2024).
DOI: 10.1007/s43465-024-01117-3
Abstrakt: Introduction: Osteoporosis is a skeletal disease characterized by loss of bone mass, reduced bone strength and increased bone fragility predisposing to fractures. This study was planned to evaluate 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 three 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 bioavailability 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. Thus, 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.
Competing Interests: Conflict of InterestThe study was sponsored by Microcore.
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Databáze: MEDLINE
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