CTRI/2023/08/056205 [Registered on: 07/08/2023] Trial Registered Prospectively
Last Modified On:
03/08/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
Effects of Teriparatide Injection for the Treatment of Men and Women with Osteoporosis Associated with Sustained Systemic Glucocorticoid Treatment who are at Increased Risk for Fracture AND Men and Postmenopausal Women with Osteoporosis who are at High Risk of Fracture
Scientific Title of Study
A Prospective, Multi-Centre, Single-Arm, Phase IV Study to Assess the Safety and Efficacy of Teriparatide Injection for the Treatment of ‘Men and Postmenopausal Women with Osteoporosis who are at High Risk of Fracture’ and ‘Men and Women with Osteoporosis Associated with Sustained Systemic Glucocorticoid Therapy who are at Increased Risk for Fracture’
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICR/22/001, Version No. 2.0, Dated 08/JUL/2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
Associate Vice President & Head - India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201, B/1, Western Express Highway, Goregaon (E),
Mumbai-400063, Maharashtra, India.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
9819767704
Fax
02243244323
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Dipesh Sonawane
Designation
Deputy General Manager – India Clinical Research
Affiliation
Sun Pharma Laboratories Ltd
Address
Sun House, Plot No. 201 B/1,
Western Express Highway, Goregaon (E),
Mumbai - 400 063, Maharashtra, India.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244323
Email
Dipesh.Sonawane@sunpharma.com
Details of Contact Person Public Query
Name
Nilesh Kadam
Designation
Senior Manager-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E),
Mumbai - 400063, Maharashtra, India.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244323
Email
Nilesh.Kadam@sunpharma.com
Source of Monetary or Material Support
Sun Pharmaceutical Industries Limited (SPIL)
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Primary Sponsor
Name
Sun Pharmaceutical Industries Limited (SPIL)
Address
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Not Applicable
Countries of Recruitment
India
Sites of Study
No of Sites = 15
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Raju KP
BGS Global Institute of Medical Science
Professor and HOD, Department of Orthopaedic,2nd Floor, Hospital Building, No. 67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore 560060, Karnataka, India. Bangalore KARNATAKA
9480289496
drrajukp.bgsgims@gmail.com
Dr Sunil Shetty
Dr. D Y Patil Hospital and Research Center
Clinical Research unit, 5th floor, Plot No. 2, Sector-5, Nerul, Navi Mumbai 400706. Thane MAHARASHTRA
9821288076
dr_sunilshetty@yahoo.in
Dr B Valya
Gandhi Hospital
Inpatient Block, Ground Floor, Department of Orthopedics, Musheerabad, Secunderabad, Telangana 500003. Hyderabad TELANGANA
9000357799
orthovalya@gmail.com
Dr Sanjay Kumar
GSVM Medical College
Ground Floor, Consultant Room, Department of Orthopaedics, Swaroop Nagar, Kanpur 208002, UP India. Kanpur Nagar UTTAR PRADESH
9889511595
dr_sanjay1@rediffmail.com
Dr Markade Pravin Narayanrao
Ishwar Institute of Healthcare
Ishwar Heights, 1st Floor, Plot No 7, Gut no. 6/1, Beside Punjabi Bhavan, Padegaon, Aurangabad- 431002, Maharashtra, India. Aurangabad MAHARASHTRA
9822314268
ishwarhealthcare@gmail.com
Dr Patil Vishal Supada
Medipoint Hospital Pvt. Ltd
Clinic building, Research department, 3rd floor, 241/1 New D.P road, Aundh 411007, Pune, Maharashtra, India. Pune MAHARASHTRA
9405431728
drvishalpatil.pentagon@gmail.com
Dr Kirankumar Mukhopadhyay
Nil Ratan Sircar Medical College and Hospital
Department of orthopedic, 1st floor, IPD Building, besides HOD room,138, Acharya Jagadish Chandra Bose Rd, Sealdah, Raja Bazar, Kolkata, West Bengal 700014. Kolkata WEST BENGAL
9433166270
orthokiran@gmail.com
Dr Mahesh G
NRR Hospital
Hesarghatta Main Road, Room no. 2,Ground floor, Department of Orthopedics, Near to Chikkabanavara Railway Station Bangalore, Karnataka 560090 Bangalore KARNATAKA
702247227
drmahesh85@gmail.com
Dr Ninama Dhavalkumar Maganbhai
Shivam Hospital
C-4, Satyanarayan Society, Gor no Kuvo, Jasodanagar Char Rasta, Maninagar, Room no. 01,2nd floor, Ahmedabad 380008, Gujarat India. Ahmadabad GUJARAT
Department of Orthopedics, Ground Floor, 11 Dhanvantri OPD Block-302004, Jaipur, Rajasthan Jaipur RAJASTHAN
9950222412
dr.mukeshaswal@gmail.com
Dr Ravikumar Mukartihal
Sparsh Hospital
2nd Floor Research Room, Department of Orthopaedics #146 Infantry Road, Opposite to Police Commissioners office Bangalore-560001. Bangalore KARNATAKA
9880082479
ravikumarmukartihal@gmail.com
Dr Tadikonda Bhavani Prasad
Visakha Institute of Medical Science
Department of Orthopedics, Hanumanthuwaka, Visakhapatnam-530040, Andhra Pradesh, India. Visakhapatnam ANDHRA PRADESH
9849125986
drbhavaniprasadtresearch@gmail.com
Dr Pramod Kumar S
Vishwaraj Hospital
OPD No. 11, Ground Floor, Department of Orthopaedics, Gate no 499, Kadamvakwasti, Solapur Road, Loni Kalbor, Pune 412201 Maharashtra India. Pune MAHARASHTRA
9492114232
survepramodkumar@gmail.com
Dr Shukla Dhaiwat Mrugeshbhai
VS General Hospital
Near Ellis Bridge, Paldi, Room no. 23, 2nd floor, Department of Orthopedics, Ahmedabad - 380006, Gujarat, India. Ahmadabad GUJARAT
8980024107
Dr.dhaiwatshukla89@gmail.com
Details of Ethics Committee
No of Ethics Committees= 15
Name of Committee
Approval Status
Clinisyd research global solutions pvt Ltd.
Approved
Ethics Committee GSVM Medical College
Submittted/Under Review
Ethics Committee of Ishwar Institute of Healthcare
Submittted/Under Review
Ethics Committee, N.R.S. Medical College
Submittted/Under Review
Ethics Committee, SMS Hospital
Submittted/Under Review
IEC, Maeers Vishwaraj Hospital
Submittted/Under Review
Institutional Ethics committee Sparsh Hospital
Submittted/Under Review
Institutional Ethics Committee, BGS Global Institute of Medical SCience
Submittted/Under Review
Institutional Ethics Committee, Dr DY Patil Hospital.
Riddhi Medical Nursing Home Institutional Ethics Committee
Submittted/Under Review
Shivam Ethics Committee
Approved
Visakha Institute of Medical Sciences Visakha Institute of Medical
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: M81||Osteoporosis without current pathological fracture,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Not Applicable
Not Applicable
Intervention
Test: Teriparatide Injection (Solution for injection in a pre-filled pen 600 mcg/2.4 ml)
20 mcg once daily subcutaneously for 24 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
85.00 Year(s)
Gender
Both
Details
Common Inclusion Criteria:
1. Patients who are willing to provide written informed consent and agree to follow the study specific requirement.
2. Patients with a diagnosis of osteoporosis who are at high risk for fracture.
3. Patients should have at least 2 vertebrae in the L1 to L4 region and at least one hip joint should be evaluable by DXA at the time of screening.
4. Male patients must have had a successful vasectomy or they and their female partners must meet the below inclusion criteria no. 8. No sperm donation is allowed during the study period.
Inclusion criteria for Men and Post-menopausal women with Osteoporosis who are at Increased Risk of Fracture:
5. Ambulatory men or post-menopausal women patients of age between > 45 to ≤ 85 years.
Inclusion criteria for Men and Women with Osteoporosis associated with Sustained Glucocorticoid Use:
6. Ambulatory men or women patients of age ≥ 18 years.
7. Patients must be taking a systemic steroid for at least 3 months prior to screening.
8. Women of childbearing potential must have a negative urine pregnancy test before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication.
ExclusionCriteria
Details
1. Patients with history of secondary osteoporosis.
2. Patients having history of metabolic bone diseases other than osteoporosis.
3. Patients having hypo/hyperthyroidism.
4. Patients with primary hyperparathyroidism.
5. Patients with severe vitamin D deficiency at screening. Vitamin D repletion will be permitted and participants may be rescreened once.
6. Patients having pre-existing hypercalcemia.
7. Patients with history of nephrolithiasis, urolithiasis, or hypercalciuria within 2 years prior to screening.
8. Patients who require hospitalization or surgical treatment for osteoporosis as judged by the investigator at time of screening or enrolment.
9. Patients with vertebral abnormalities at L1 to L4 that may interfere with the vertebral assessment by DXA.
10. Patients with history of hip replacement surgery.
11. Patients with significantly impaired hepatic function; multiple transaminase elevation of any magnitude which, in the opinion of the investigator, indicative of significant hepatic impairment as per the investigator’s discretion.
12. Patients with unexplained elevations of serum alkaline phosphatase greater than 2 times of ULN, or as per the investigator’s judgement.
13. Patients with significantly impaired renal function.
14. Patient who have received prior treatment with PTH or parathyroid hormone-related peptide (PTHrP), including abaloparatide.
15. Patients who have received previous treatment with bisphosphonates in the last 12 months prior to screening.
16. Patients who have received previous treatment with any other drug affecting bone metabolism in the last 3 months prior to screening.
17. Patients who are receiving treatment with anticonvulsants that affect Vitamin D metabolism at the time of screening or receiving chronic heparin therapy within the 14 days prior to the screening.
18. Patients receiving or intended to receive other unacceptable concomitant medicines.
19. Patients with history of any cancer within last 5 years prior to screening.
20. Patients with history of osteosarcoma at any time prior to screening.
21. Patients who have undergone prior external beam or implant radiation therapy to the skeleton.
22. Patients with clinically significant cardiovascular, hepatic, renal, metabolic, hematological, immunological, pulmonary, or gastrointestinal disorders as judged by the investigator.
23. Patients with concurrent medical conditions that, in the judgment of the Investigator, might interfere with the conduct of the trial, confounded the interpretation of the trial results, or endangered the patient’s well-being.
24. Patients with previous history of gastric bypass surgery, or any medical condition that would be expected to affect drug absorption within last 1 year prior to randomization.
25. Patient with history of HIV, Hepatitis B and Hepatitis C.
26. Patients with history of meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for alcohol or substance abuse or dependence within the 6 months before enrolment.
27. Prior participation in any clinical trials, involving experimental or investigational drugs, within 6 months before screening or intended to participate during the study period. Patients who have previously participated in any clinical trial involving any experimental PTH or PTHrP preparations are also not eligible for the study.
28. Patients with history of hypersensitivity or allergic reaction to study medication or its component(s).
29. Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
30. Investigator, study personnel, Sponsor representatives and their first-degree relatives.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Safety: Proportion of patients with treatment-emergent adverse events (TEAEs)
Baseline, Week 4, 12 and 24
Secondary Outcome
Outcome
TimePoints
Efficacy: Percent change from baseline in lumbar spine BMD at Month 3 & 6
Month 3 & 6
Efficacy: Percent change from baseline in total hip BMD at Month 6
Month 6
Efficacy: Percent change from baseline in femoral neck BMD at Month 6
Month 6
Exploratory: Change from baseline in FRAX score (Major osteoporotic fracture) at Month 6
Month 6
Exploratory: Change from baseline in FRAX score (Hip fracture) at Month 6
Month 6
Target Sample Size
Total Sample Size="155" Sample Size from India="155" 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
Phase 4
Date of First Enrollment (India)
14/08/2023
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="0" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a prospective,
phase IV, single arm, multicenter, open-label study. The study will be
conducted at approximately 10-15 number of centers in India, having qualified
Investigators. The study will be initiated only after the receipt of regulatory
and ethics committee (EC) approval. After obtaining the informed consent,
patients will be screened by undergoing various assessments as mentioned in
Schedule of Assessment. After confirming the eligibility, patients will be enrolled
by allotting the enrollment number. The enrolled patients will be given study
drug Teriparatide Injection [Solution for injection in a pre-filled pen 600
mcg/2.4 ml (Synthetic Origin)] 20 mcg once daily subcutaneously. Treatment
duration will be 24 weeks (approximately 6 months). During the study,
assessments will be performed as mentioned in Schedule of Assessment.