| CTRI Number |
CTRI/2020/10/028767 [Registered on: 29/10/2020] Trial Registered Prospectively |
| Last Modified On: |
26/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To Evaluate the Efficacy and Safety of Bio-D3® Plus Vs Shelcal® of Patients with Osteoporosis of lumber spine |
|
Scientific Title of Study
|
A Prospective, Single-center, Open label, Randomized, Parallel-group, Comparative Clinical Study to Evaluate the Efficacy and Safety of Bio-D3® Plus Vs Shelcal® in the Treatment of Patients with Osteoporosis of Lumbar Spine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-017-CaEl(F)-2019 Version 2.0/dated 07-sep-2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pravin Markade |
| Designation |
Consultant Orthopedics |
| Affiliation |
Ishwar Health Institute care |
| Address |
Ishwar Insitute of Health care
Ishwar Heights 1st Floor Plot no 7 gut no.6/1 beside Punjabi bhawan padegaon, Aurangabad,India
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9822314268 |
| Fax |
|
| Email |
drpravin.iicr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravin Markade |
| Designation |
Consultant Orthopedics |
| Affiliation |
Ishwar Health Institute care |
| Address |
Ishwar Insitute of Health care
Ishwar Heights 1st Floor Plot no 7 gut no.6/1 beside Punjabi bhawan padegaon, Aurangabad
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9822314268 |
| Fax |
|
| Email |
drpravin.iicr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravin Markade |
| Designation |
Consultant Orthopedics |
| Affiliation |
Ishwar Health Institute care |
| Address |
Ishwar Insitute of Health care
Ishwar Heights beside Punjabi bhawan padegaon
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9822314268 |
| Fax |
|
| Email |
drpravin.iicr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Macleods Pharamaceuticals Ltd. |
|
|
Primary Sponsor
|
| Name |
Dr Pravin Markade |
| Address |
Ishwar Heights 1st floor plot no.07 gut no 6/1 Beside Punjabi bhawan, Padegaon |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pravin Markade |
Ishwar Institute of Health care |
Ishwar Institute of Health care
Ishwar Heights Beside Punjabi bhawan, Padegaon, Aurangabad-431002
Aurangabad
MAHARASHTRA |
9822314268
drpravin.iicr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Ishwar Institute of Health care |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bio-D3 Plus |
Calcitriol 0.25 mcg + Elemental calcium 200 mg Capsule_2 times_84 days |
| Comparator Agent |
Shelcal |
Calcium 500 mg + Vitamin D3 250_2times_84 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult male or female patients aged between 18 to 65 years of age (both ages inclusive).
2.Patients diagnosed by DXA as osteoporotic, with BMD score of T <-2.5 in lumbar spine.
3.Patients with inadequate levels of Calcium/Calcitriol in the opinion of investigator requiring study treatment.
4. Patients willing to use only oral Acetaminophen/Paracetamol (less than or equal to 4 g per day) for aches and pains experienced during the trial.
5. Women of childbearing potential must be willing to consistently use an appropriate method of contraception.
6.Willingness to give their written informed consent to participate in the study.
7.Patients willing to comply with all aspects of the protocol.
|
|
| ExclusionCriteria |
| Details |
1.Patients who have known history of other bone/metabolic disease (e.g. osteomalacia or osteogenesis imperfecta) and liver cirrhosis.
2.Patients who have unstable liver disease (as defined by the known history of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
3.Patients have history of malabsorption syndrome or any gastrointestinal disorders associated with malabsorption.
4.Patients with osteomyelitis or osteonecrosis.
5.Patient has a history or evidence of lumbar fracture.
6.Patients who are known to have history of calcium intolerance.
7.Patients who are receiving Ayurvedic, Unani, Herbal, and Homeopathy therapy as stable dose in the past 3 months from screening for treatment of osteoporosis.
8.Patients with a known history of hypersensitivity to any of the active or inactive ingredients of the investigational products.
9.Patients with history of hypercalcemia, hypercalciuria, or active kidney stone disease.
10.Patients receiving glucocorticoids, estrogens, thyroid hormone, parathyroid hormone, fluoride, bisphosphonates, calcitonin, thiazide diuretics, barbiturates, or antiepileptic medications in the past 3 months from screening.
11.Patients with known history of fracture in the past 6 months from screening.
12.Patients with known history of malignancy
13.Patients who received any organ or bone marrow transplantation.
14.Any clinical abnormality which, in the opinion of the investigator, will prevent the patient from completing the study or interfere with the interpretation of the study results.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percent change in bone mineral density at lumbar spine from baseline to Day 85 in both treatment groups
Change in a 0-100 mm visual analogue scale score from baseline to Day 85 in both treatment groups
|
day 85
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in a 0-100 mm visual analogue scale score from baseline to Day 43 in both treatment groups
Change in serum calcium level on Day 85 in both the treatment groups
|
day 85 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/11/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Prospective, Single-center, Open label,
Randomized, Parallel-group, Comparative Clinical Study to Evaluate the Efficacy
and Safety of Bio-D3® Plus Vs Shelcal® in the Treatment of Patients with
Osteoporosis of Lumbar Spine
There are 5 scheduled study site visits during the
entire study period; Visit 1 (Screening period/Up to 7 days), Visit 2
(Randomization/Start of study treatment with IP), Visit 3 (Treatment period/Day
43 (±2 days), Visit 4 (End of treatment [EOT]/Day 85 (±2 days) and End of study
(EOS)/Telephonic safety follow-up after 7 days of last dose of IP, Individual participation
of the patient in the study will last for up to 94 days.
Patients will
undergo screening study procedures and assessments upon signing of informed
consent form (ICF). Detailed medical/surgical, prior and concomitant medication
details will be asked from patients and recorded.
Upon screening assessments and procedures, a total
of 60 eligible patients will be randomized in 1:1 ratio to receive treatment
from any one study treatment groups. Treatment A received Bio-D3 plus and treatment B received shelcal.
|