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CTRI Number  CTRI/2023/05/052618 [Registered on: 15/05/2023] Trial Registered Prospectively
Last Modified On: 27/02/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to study effects of Teriparatide in the Treatment of Postmenopausal Osteoporosis. 
Scientific Title of Study   A phase IV, prospective, open label, single-arm, multicenter clinical study to evaluate the safety and efficacy of teriparatide in patients with postmenopausal osteoporosis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ALK05-TERI2 Version 2.1, 24/Feb/2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akhilesh Sharma 
Designation  President & Chief Medical Officer 
Affiliation  Alkem Laboratories Limited 
Address  Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel, Mumbai MAHARASHTRA 400013, India

Mumbai (Suburban)
MAHARASHTRA
400013
India 
Phone  022-39829999  
Fax    
Email  akhilesh.sharma@alkem.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Akhilesh Sharma 
Designation  President & Chief Medical Officer 
Affiliation  Alkem Laboratories Limited 
Address  Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel, Mumbai MAHARASHTRA 400013, India


MAHARASHTRA
400013
India 
Phone  022-39829999  
Fax    
Email  akhilesh.sharma@alkem.com  
 
Details of Contact Person
Public Query  
Name  Dr Dattatray Pawar 
Designation  Senior Manager 
Affiliation  Alkem Laboratories Limited 
Address  Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel, Mumbai MAHARASHTRA 400013, India

Mumbai (Suburban)
MAHARASHTRA
400013
India 
Phone  022-39829999  
Fax    
Email  dattatray.pawar@alkem.com  
 
Source of Monetary or Material Support  
Alkem Laboratories Limited, Alkem House, Senapati Bapat Marg,Lower Parel, Mumbai –400013, Maharashtra 
Enzene Biosciences Limited, Plot No. 165/1/26, Block T, Bhosari MIDC Area, Pune-411057,Maharashtra 
 
Primary Sponsor  
Name  Enzene Biosciences Limited 
Address  Enzene Biosciences Limited, Plot Number 165/1/26, Priyadarshani Society, Next to Gujjar Bharath gas) T 26, Internal Rd, MIDC, Bhosari, Pune, Maharashtra 411026 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Alkem Laboratories Limited  ALKEM HOUSE, “Devashish”, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel west, Mumbai 400013 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amit Joshi  HBT Trauma Care Hospital  HBT trauma care hospital , Ajgaokar plot , Western express highway Jogeshari , East Mumbai 400060
Mumbai
MAHARASHTRA 		 7702977885

dr.amitjoshi85@gmail.com 
Dr Sachin Gupta  Imperial Hospital & Research Centre  Imperial Hospital Research Center A-56 Shastri Nagar Near Kawatia Circle Jaipur -302016, Rajasthan India
Jaipur
RAJASTHAN 		 9414064560

drsachingupta72@gmail.com 
Dr Pravin Markade  Ishwar Institute of Health Care  Ishwar Heights, 1st floor, plot no 7, gut no 6/1, beside Punjabi bhavan, Padegaon, Aurangabad-431002, Maharashtra, India.
Aurangabad
MAHARASHTRA 		 9822314268

drpravinmarkade.iicr@gmail.com 
Dr Hrishikesh Patkar  Lifepoint Multispecialty hospital  Lifepoint Multispecialty hospital, 145/1, Mumbai Bangalore highway, Near Hotel Sayaji , Wakad, Pune-411057, Maharashtra
Pune
MAHARASHTRA 		 9011267776

patkarhrishikesh9@gmail.com 
Dr Swaroop Solunke  Medipoint Hospitals Pvt. Ltd.  241/1 New D. P. Road, Aundh, Pune-411007, Maharashtra, India.
Pune
MAHARASHTRA 		 9921101070

drswaroopsolunke.medipoint@gmail.com 
Dr Sanket Sorate  Sanjeevani criticare and Research centre  Narayan sankul ,Near Mahalaxmi Talkies, Dindori Road , Panchavati , Nashik- 422003
Nashik
MAHARASHTRA 		 9850686858

drsanket.sanjeevani@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Ethics Committee of Ishwar Institute of Health Care  Approved 
Ethics committee of Trauma care hospital  Approved 
Imperial Hospital Ethics Committee  Approved 
Institutional Ethics Committee, King George Hospital   Submittted/Under Review 
LPR Ethics Committee  Approved 
Pentamed Ethics Committee  Approved 
Shree Siddhivinayak Hospital ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M810||Age-related osteoporosis without current pathological fracture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Teriparatide Injection IP 600 mcg/2.4 mL  Teriparatide Injection IP 600 mcg/2.4 mL, subject will self-administer 20 mcg from the injection into the thigh or abdominal wall once daily for 24 weeks 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1. Women with at least 5 years of post menopause, aged > 50 to 80 years
2. Postmenopausal women with osteoporosis  
 
ExclusionCriteria 
Details  1. known hypersensitivity to teriparatide or any of its excipients
2. pre-existing hypercalcemia
3. severe renal impairment
4. metabolic bone diseases other than postmenopausal osteoporosis.
5. unexplained elevation of alkaline phosphatase
6. Prior external beam or implant radiation therapy to the skeleton.
7. patients with skeletal malignancies or bone metastases should be excluded from the treatment with teriparatide.
8. Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Number of AEs and number of adverse reactions  26 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Number of serious adverse reaction and serious adverse drug reactions during the study period.
2. percentage change from baseline to week 24 in bone mineral density at lumbar spine and femoral neck
3. change in baseline in PD biomarkers and bone specific alkaline phosphatase at week 12 and week 24 		 week 24 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   13/06/2023 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a phase IV, prospective, open label, single-arm, multicentre clinical study to evaluate the safety and efficacy of teriparatide in patients with postmenopausal osteoporosis.

A total 200 subject who meet eligibility criteria will be given teriparatide (Enzene Biosciences Ltd) 20 mcg subcutaneously once only.

The study duration will be approximately 53 weeks considering 24 weeks of recruitment period and 29 weeks of study period.

The study comprises of 3 periods:

Screening Period: It will last up to 3 weeks
Treatment Period: It will last for 24 weeks; all subjects will receive Denosumab (Enzene Biosciences Ltd) 20 mcg subcutaneously once only;
Follow-up Period: It will last for 2 weeks after completion of Treatment Period.

Primary Objectives:
The primary objective of this study is to evaluate the safety of teriparatide injection in patients with postmenopausal osteoporosis.

Secondary Objectives:
To evaluate the efficacy of teriparatide injection in patients with postmenopausal osteoporosis.
To assess the pharmacodynamics (PD) response of teriparatide injection in patients with postmenopausal osteoporosis


 
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