| CTRI Number |
CTRI/2012/05/002631 [Registered on: 07/05/2012] Trial Registered Retrospectively |
| Last Modified On: |
20/06/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effects of CollagenCal™ in the management of Osteoporosis in women. |
|
Scientific Title of Study
|
A RANDOMIZED, OPEN LABEL, MULTI-CENTER, TWO ARMS PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CollagenCal� IN COMPARISON WITH A FORMULATION CONTAINING CALCIUM + VITAMIN D3 IN THE MANAGEMENT OF OSTEOPOROSIS IN WOMEN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/ORT/011/10 Version No.:03 / Date : 23/05/11 |
Protocol Number |
| U1111-1124-0453 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B Thanigai Arasu M S Ortho |
| Designation |
Orthopaedician |
| Affiliation |
Roshini Health Centre |
| Address |
Roshini Health Centre
No 124th Street, Halls Garden, Royapettah, Chennai, INDIA
Chennai
TAMIL NADU
600014
India |
| Phone |
9894618266 |
| Fax |
|
| Email |
roshinihealthcentre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VT Sriraam MBBS MD |
| Designation |
Medical Director |
| Affiliation |
Auroville Health Care Research and Development Private Limited |
| Address |
Auroville Health Care Research and Development Private Limited
No 180/109 Rangarajapuram Main Road Kodambakkam Chennai INDIA
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
sriraamvt@aurovillehealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VT Sriraam MBBS MD |
| Designation |
Medical Director |
| Affiliation |
Auroville Health Care Research and Development Private Limited |
| Address |
Auroville Health Care Research and Development Private Limited
No 180/109 Rangarajapuram Main Road Kodambakkam Chennai INDIA
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
sriraamvt@aurovillehealthcare.com |
|
|
Source of Monetary or Material Support
|
| Nitta Gelatin India Limited |
|
|
Primary Sponsor
|
| Name |
Nitta Gelatin India Limited |
| Address |
Post Box No 4262, 50/1002,
SBT Avenue, Panampilly Nagar
Cochin 682036
INDIA
Fax: 91-484-2310568, 4099456
Tel: 2317805, 4099444
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Auroville Healthcare R D Pvt Ltd |
No 180/109 Rangarajapuram Main Road Kodambakkam Chennai 600024 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr T R Ramesh Pandian D Ortho |
Deepam Hospital Limited |
327 Muthurangam Road West Tambaram
Chennai 600045
Chennai
TAMIL NADU |
9444943019
trrpandian@gmail.com |
| Dr M Sundaresan D Ortho |
Mother Orthopedics |
85/134, Big Street Tiruvannamalai606601
Kancheepuram
TAMIL NADU |
9443229610
drsundaresan61@yahoo.co.in |
| Dr B Thanigai Arasu |
Roshini Health Centre |
No 12, 4th Street,
Halls Garden,
Royapettah, Chennai
Chennai
TAMIL NADU |
9894618266
roshinihealthcentre@gmail.com |
| Dr Arvind Rajagopalan D Ortho PGDMLS |
S M C Ortho and Trauma Clinic |
12, Violet Flats Ground Floor Vellalar Street Mogappair-West Chennai600037
Chennai
TAMIL NADU |
9840025970
arvindrajagopalan@smcortho.com |
| Dr S Anbazhagan MS ortho |
V S R Ortho Hospital |
Kancheepuram 631501
Kancheepuram
TAMIL NADU |
9444456197
sunderrajananbazhagan@gmail.com |
| Dr R Prabhakar M S Ortho |
Vyasar Bone and Joint Clinic |
No62, MeenambalSalai, Krishnamurthy Nagar Chennai 600118
Chennai
TAMIL NADU |
9381509648
prabhakarortho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Global Ethics Committee, Chennai - 600049, Tamil Nadu, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M810||Age-related osteoporosis without current pathological fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium + VitaminD3 |
10mg ORAL TABLET to be taken with Water for 12 months |
| Intervention |
CollagenPeptide + VitaminD3 + VitaminC + Calcium Citrate
|
10mg Once Daily ORAL To be taken with Water for 12 months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Subjects whoare ambulatory women of 40 to 65 years oldWhoare willing to give informed consent
Whoare willing to comply with the study procedures and restrictions
are diagnosed by DEXA as osteoporotic, with BMD score of T< -2.5 in Lumbar Spine (L1-L4) and/or Total Hip [WHO Diagnostic Criteria for Osteoporosis]
are diagnosed with Primary osteoporosis
|
|
| ExclusionCriteria |
| Details |
• Subjects who are previously diagnosed with secondary osteoporosis or got presently diagnosed by clinical lab investigations.
• Subject who are having a BMI of more than 30
• had or has fracture, as observed from medical history with in past 6 months.
• Subjects who had hysterectomy
• Subjects who had received glucocorticoids, estrogens, thyroid hormone, parathyroid hormone, fluoride, bisphosphonates, calcitonin, thiazide diuretics, barbiturates, antiepileptic medication for the past 3 months.
• Subjects who are suffering from systemic diseases (cardiac, hepatic, renal, hemopoietic) which the investigator feels will compromise the subject’s safety.
• Subjects who are suffering from disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
• Pregnant, lactating women and women of child bearing potential, not practicing effective methods of contraception and planning a pregnancy during the study period.
• Subjects who are known to have or tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen
• Any other metabolic bone disease or secondary cause to bone loss that is not controlled and will interfere with the interpretation of the findings.
• Malignancy
• Subjects who had or has received any organ or bone marrow transplantation.
• Any laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results.
• Subjects who are known to have calcium intolerance.
• Any physical or psychiatric disorder which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results.
• Alcohol or substance-abuse or smoking within the last 3 months.
• Subjects who recently underwent gastro-intestinal contrast studies and/or radionuclide tests before one week.
• Subjects who are having serum Creatinine1.3mg/dL, Serum calcium 10 mgl/dL.
• Subjects who are having systolic BP 175 mm Hg or diastolic BP 105mm Hg.
• Subject’s who are in suspect of primary hyperparathyroidism with serum calcium 10mg/dL combined with PTH 5.0 mmol/L or serum calcium 9.8mg/dL combined with PTH ≥7.0 mmol/L.
• Subjects who used Ayurvedic formulation or any form of CAM (Complementary Alternative Medicine) therapy in the preceding 3 months
• Subjects who are currently enrolled or participated in the any other trial(s) in preceding 3 months |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage decrease in the following markers from baseline to end of Treatment period
o Serum – CTx: 23- 35%
o Serum OC and Serum BAP : 13- 20%
o Free Urinary DPD : 13 - 20%
|
Percentage Decrease in the following Markers from Baseline to 6months and End of Treatment
o Serum – CTx: 23- 35%
o Serum OC and Serum BAP : 13- 20%
o Free Urinary DPD : 13 - 20%
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Increase in percentage of BMD from baseline to the end of treatment Period
• Improvement in QoL from baseline to the end of treatment Period
|
Base Line and End of study which is after one year
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
29/09/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
PROTOCOL NUMBER: AHC/ORT/011/10
STUDY TITLE: A Randomized, Open Label, Multi-center, Two
Arms Parallel Group Study to Evaluate the Efficacy and Safety of CollagenCalâ„¢
in Comparison with a Formulation Containing Calcium + Vitamin D3 in the
Management of Osteoporosis in Women.
SUMMARY:
·
The purpose
of this study was to ascertain the efficacy and safety of CollagenCalâ„¢ in
improving bone mineral density in women with osteoporosis between the ages of
40 to 65 years by evaluating percentage decrease in the bone turnover markers
and improvement in BMD and overall Quality of Life (QoL) of the subjects and to
compare the results with active control arm.
·
The
treatment arm received CollagenCalâ„¢ and the control arm received a formulation
with Calcium + Vitamin D3, both to be consumed once daily for a period of one
year.
·
The analysis
of the efficacy data of the subjects in the treatment arm shows that the
primary objectives of percentage decreases in the Biomarkers – Serum CTX, Serum OC, and Serum BAP from baseline to
end of study have been met with statistical significance. However the data from
uDPD does not show similar results. The percentage decreases in all four
biomarkers do not show statistically significant difference in the comparative
analysis between CollagenCalTM and the comparator.
·
Similarly,
CollagenCalTM shows significant
improvement in the Nutritional Score and Quality of Life improvement in the
subject over a year but fails statistically in a comparative analysis.
·
The bone
mineral density changes as measured by DEXA Scan show that CollagenCalTM
is efficacious as evident by significant change in the L1-L4 lumbar Scores (T
Score, Z Score, BMD) but baseline to end of treatment. But the Total Hip Score are found to be
statistically insignificant. Similarly, CollagenCalTM fails to show
statistically distinguishable difference in the comparative analysis of the
DEXA Scan parameters with the comparator. The same results hold true when the
changes are measured from baseline to 6 months into treatment and that same midpoint
to end of treatment.
·
Thus, the
analysis to assess the comparative efficacy of CollagenCalâ„¢ with a formulation
containing Calcium + Vitamin D3 in the management of osteoporotic women and the
corresponding result showed that the difference between the CollagenCalâ„¢ and
the Comparator with respect to the change in certain efficacy parameters was
not statistically significant. However, the analysis of Total Nutritional
Status Scores and Total QoL Scores, including individual assessment scores of
QoL showed that the CollagenCalâ„¢ is significantly better than the Comparator in
terms of improvement in the MNA Total Score, QoL Total Score and QoL Individual
Assessment Scores from baseline to end of the treatment period.
|