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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

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Abstract

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.

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Data availability

The data that supports the findings of this study will be available on request to the corresponding author.

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Acknowledgements

We acknowledge the sponsor (Microcore) and the CRO (ki3 Pvt. Ltd).

Author information

Authors and Affiliations

  1. Department of Orthopaedics, Mahatma Gandhi Medical College and Research Institute, Puducherry, India

    Krishna Gopal

  2. Integrative Medicine, Medical Affairs, Ki3 Private Limited, Chennai, Tamil Nadu, India

    Bijoy Deb

  3. Department of Pharmacology, Mahatma Gandhi Medical College and Research Institute, Puducherry, India

    N. Uma

  4. Department of Pharmacology, Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur, Puducherry, India

    Sakthi Balan

  5. Microcore Research Labs India Pvt Ltd, Erode, Tamil Nadu, India

    GayathriSivakumar, M. Chandra Mohan & Priya Rajendran

Authors
  1. Krishna Gopal
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  2. Bijoy Deb
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  3. N. Uma
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  5. GayathriSivakumar
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  6. M. Chandra Mohan
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  7. Priya Rajendran
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Corresponding author

Correspondence to Sakthi Balan.

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Conflict of Interest

The study was sponsored by Microcore.

Ethical Standard Statement

This article does not contain any studies with human or animal subjects performed by the any of the authors.

Informed Consent

Informed consent was obtained from the study participants.

Limitations

Sample size was small and only relative bio availability was calculated in our study. Baseline Vitamin D 3 and PTH levels could have been monitored to rule out other factors affecting calcium metabolism.

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Gopal, K., Deb, B., Uma, N. et al. 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. JOIO 58, 535–541 (2024). https://doi.org/10.1007/s43465-024-01117-3

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  • DOI: https://doi.org/10.1007/s43465-024-01117-3

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