RESULTS AND DISCUSSIONS
This
novel combination of ingredients of
Microcore NESC®, has shown
a better oral relative bio availability of calcium,
better improvement of BMD over a treatment period of
12 weeks, while compared to other preparations like
Shelcal and CCM. However,
Microcore NESC® and Shelcal is
showing a comparable performance in many other
parameters, the bioavailability and side effect
profile is better with
Microcore NESC®. This study has also
highlighted that
Microcore NESC® treatment has shown to bring
down osteocalcin levels, which is marker for
reduction in osteoporosis. Thus,
Microcore NESC®
has natural Strontium in it. Strontium has a dual
effect of inhibiting bone resorption (Osteoclastic )
and stimulating new bone formation (Osteoblastic)
and its biological behavior as well as the
metabolism and distribution of strontium mimics that
of calcium. Studies have shown that Strontium
Supplements increases bone mass density and reduces
the risk of vertebral and normal bone fracture.
DEMOGRAPHIC DETAILS
Gender |
Group |
Total |
CCM |
NESC |
Shelcal |
Female |
13 |
11 |
12 |
36 |
68.40% |
61.10% |
70.60% |
66.70% |
Male |
6 |
7 |
5 |
18 |
31.60% |
38.90% |
29.40% |
33.30% |
Total |
19 |
18 |
17 |
54 |
This
novel combination of ingredients has shown a better
oral relative bio availability of calcium, better
improvement of BMD while compared to other
preparations like Shelcal and CCM. There is a
significant improvement in the BMD(T score) post
treatment with NESC and Shelcal.
Microcore NESC®
is showing a higher significance when compared to
Shelcal. The progression from osteopenia to
Osteoporosis has been reduced, as serum carboxylated
osteocalcin levels decreased from base line to post
study values, in Microcore NESC®
treatment group. However, there is no statistically
significant reduction in any of the treatment
groups. There is a 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%) at 270 minutes after administration.The
relative bio availability of
Microcore NESC®
with respect to shelcal was 93%. For calcium, which
is an endogenous substance, measurement of absolute
bioavailability of an oral dose requires the use of
isotopic methods, but for assessing relative oral
bioavailability, the pharmacokinetic method is a
convenient and acceptable tool. Hence, the same was
applied here. This study has also highlighted that
NESC treatment has shown to bring down osteocalcin
levels, which is marker for reduction in
osteoporosis. Thus, 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 and
Patient compliance to the test product was
exceptionally good, through out the study.
Medical Journal Publication data is available on
genuine request
."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", has been accepted for publication in Indian Journal
of Orthopaedics.
Indian
Journal of Orthopaedics
Received: 29 November 2023 /
Accepted: 30 January 2024
Indian Orthopaedics Association 2024
https://link.springer.com/article/10.1007/s43465-024-01117-3