CTRI

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CTRI Number

CTRI/2021/09/036190 [Registered on: 03/09/2021] Trial Registered Prospectively

Last Modified On:

29/03/2023

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Biological

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A study of Denosumab in patients.

Scientific Title of Study

A Randomized, Double-Blind, Active-Controlled, Parallel Arm, Multicenter Study Comparing Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Denosumab of Intas Pharmaceutical Limited (60 mg/mL) with ProliaÂ® in Postmenopausal Women with Osteoporosis

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
0774-19 (Version 2.0, Dated: 14-Sep-2020)	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Mr Prashant Modi
Designation	Sr. General Manager
Affiliation	Lambda Therapeutic Research Ltd
Address	Lambda House, Department of Project Management & Regulatory Affairs, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G. Highway,Gota Ahmadabad GUJARAT 382481 India
Phone	07940202375
Fax	07940202021
Email	prashantmodi@lambda-cro.com

Details of Contact Person
Scientific Query

Name	Dr Naman Shah
Designation	General Manager
Affiliation	Lambda Therapeutic Research Ltd
Address	Lambda House, Department of CTM Medical Services, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G. Highway,Gota Ahmadabad GUJARAT 382481 India
Phone	07940202389
Fax	07940202021
Email	namanshah@lambda-cro.com

Details of Contact Person
Public Query

Name	Mr Prashant Modi
Designation	Sr. General Manager
Affiliation	Lambda Therapeutic Research Ltd
Address	Lambda House, Department of Project Management & Regulatory Affairs, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G. Highway,Gota Ahmadabad GUJARAT 382481 India
Phone	07940202375
Fax	07940202021
Email	prashantmodi@lambda-cro.com

Source of Monetary or Material Support

Intas Pharmaceutical Limited (Biopharma Division), Plot No. 423/P/A/GIDC, Sarkhej - Bavla Highway, Moraiya, Ahmedabad â€“ 382213. Gujarat, India.

Primary Sponsor

Name	Intas Pharmaceutical Limited Biopharma Division
Address	Plot No. 423/P/A/GIDC, Sarkhej - Bavla Highway, Moraiya, Ahmedabad â€“ 382213. Gujarat, India
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 76
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Girish Bhatia	7-Orange Hospital	Department of Clinical Research, Room No.NA, Pawana Nagar Housing Society, Chinchwad, Pimpri-Chinchwad, Pune-411033, Maharashtra, India Pune MAHARASHTRA	8983377103 drgirishbhatia@gmail.com
Dr Ashish Chaudhry	Aakash Healthcare Super speciality Hospital	Department of Clinical Research, Room No. NA,Aakash Healthcare Super Speciality Hospital Hospital Plot, Road no. 201, Dwarka Sector-3, New Delhi, Delhi 110075 New Delhi DELHI	9818444333 director@aakashhealthcare.com
Dr P Krishna Saravanth	ADITYA MULTI SPECIALITY HOSPITAL	Department of Clinical Research, Room No. NA,D. no. 13-3-52 , 3rd Line ,Gunturivari Thota, Opp. Road RTC bus stand, Kamaraju scan Centre road, Guntur- 522001 Andhra Pradesh, India Guntur ANDHRA PRADESH	8500454389 sravanthpakanati@gmail.com
Dr Sharad Purohit	Ahmedabad Bariatrics & Cosmetics Pvt Ltd. (Asian Bariatrics Hospital)	Department of Clinical Research, Room No. 235/2, B/s. Tata Motors Showroom, Opposite Rajpath Club, S. G. Highway, Bodakdev- 380015 Ahmadabad GUJARAT	7966556667 dr_sharadpurohit@hotmail.com
Dr Saurabh Sah	Alexis Multi-Speciality Hospital Pvt. Ltd	Department of Clinical Research, Room No. NA, Mankapur, Koradi Road, Nagpur-440030, Maharashtra Nagpur MAHARASHTRA	9423637719 drsaurabhsah@gmail.com
Dr Aman Khanna	Aman hospital and Research center	Department of Clinical Research, Room No. 15 Shashwat, Opp, E.S.I Hospital Sarabhai, Gotri Road Vadodara Gujarat - 390021 India" Vadodara GUJARAT	9904402122 amankhanna1974@gmail.com
Dr Rishi Sanghavi	Anand Surgical Hospital PVt Ltd.	Department of Clinical Research, Room No. NA,Anand Surgical Hospital Pvt Ltd, Memco Cross Road, Naroda road Ahmadabad GUJARAT	9879099178 drrishisanghavi.research@gmail.com
Dr Manish Sumer Singh	Ananta Institute of Medical Sciences & Research Centre	Department of Clinical Research, Room No. NA,NH.8, Village: kaliwas, Teh.: Nathdwara, District: Rajsamand- 313202, Rajasthan, India Rajsamand RAJASTHAN	7014546880 clinicalresearch@anantamedicity.com
Dr Arvind Asopa	Asopa Hospital	Department of Clinical Research, Room No. NA, Asopa hospital, 93B, Tagore Nagar, Near DCM, Ajmer Road- 302021 Jaipur RAJASTHAN	7222818101 asoparesearch@gmail.com
Dr G Sathish Reddy	Aster Prime Hospital	Department of Clinical Research, Room No. NA,Aster Prime Hospitals,Opp,Passportseva Kendra,Ameerpet,Hyderabad-500038,Telangana,India Hyderabad TELANGANA	9849563360 drgsreddy@gmail.com
Dr Kaushal Ramanlal Anand	B.J. Medical Collage and Civil Hospital	Department of Orthopaedics, New Civil Hospital, Asarwa - 380016 Ahmadabad GUJARAT	9909013564 kaushal87anand@gmail.com
Dr Pritish Khardikar	Baj RR Hospital & Research Centre	Department of Clinical Research, Room No. NA, BAJ RR Hospital and Research Centre,P-14, MIDC, Phase-I, Milap Nagar-421203 Thane MAHARASHTRA	9820862320 drpriteshkhardikar@gmail.com
DrChandrasekhar Srikhantaiah	Chanre Rheumatology &immunology Centre& Research	Department of Clinical Research, Room No. NA,414/65 20th main, Chord Rd, 1st Block, Rajajinagar, Bengaluru, Karnataka 560010 Bangalore KARNATAKA	8042516699 chandrashekara_s@yahoo.com
Dr Naisar Dilip Nahar	Chopda Medicare & Research Centre Pvt. Ltd, Magnum Heart Institute	Department of Clinical Research, Room No. NA, Chopda Medicare and Research Centre Pvt. Ltd ,Magnum Heart Institute Canada Corner- 422005 Nashik MAHARASHTRA	9970222227 dr.naisar@yahoo.com
Dr R P Saini	Dhanvantari Hospital	Department of Clinical Research, Room No. NA, Dhanvatri Hospital, Near Mandara Bus stand, New Sanganer Road, Mansarovar- 302020 Jaipur RAJASTHAN	7222818101 dhanvantriresearch@gmail.com
Dr Hardik Shah	DHS Hospital	Department of Clinical Research,Room No.N/A, Hospital Vastrapur Lake-Himalaya Mall Link Road, Sunrise Park, Vastrapur,Ahmedabad-380054, India Ahmadabad GUJARAT	9727726933 doc.hardikshah@gmail.com
Dr Rakesh Mahajan	Dr. B L Kapur Memorial Hospital	Department of Clinical Research, Room No. NA,Dr. B L Kapur Memorial Hospital, Pusa Road- 110005, New Delhi, India New Delhi DELHI	9810034040 rakeshmahajan26@yahoo.co.in
Dr Krishna Chaitanya	Endolife Specialty Hosptial	Department of Clinical Research,Room NO,N/A,Door No: 12-12-94, Old Club Road, Kotha Peta, Guntur-522001, Andhra Pradesh, India Guntur ANDHRA PRADESH	8197185447 krishnachaitanyaponduri@gmail.com
Dr Yogesh Kathiriya	Global Hospital	Department of Clinical Research, Room Number 110, 4 Floor, sarthana Jakatnaka Surat Gujarat - 395006 India Surat GUJARAT	9967079992 dryogeshkcr@gmail.com
Dr KV Satyanarayana	Help Hospitals Private Limited	Department of Clinical Research, Room No. NA,Help Hospitals Private Limited D.No.27-29-23, Behind Victoria Museum, Governerpet Vijayawada Krishna Andhra Pradesh - 520002 India Krishna ANDHRA PRADESH	9866904338 crhelphospitals@gmail.com
DrSachin Gupta	Imperial Hospital & Research Center	Department of Clinical Research, Room No. NA,Imperial Hospital & research centre, A-56, near kanwatia circle, Shashtri Nagar, Jaipur-302016 Jaipur RAJASTHAN	9414064560 drsachingupta72@gmail.com
Dr Deepak Raina	Indian Spinal Injuries Centre	Department of Clinical Research, Room No. NA, Indian Spinal Injuries Centre ,Sector C, Vasant Kunj-110070 New Delhi DELHI	9811093225 deepakraina@hotmail.com
DrSunil Dachepalli	Innovate Medical center	Department of Clinical Research, Room No. NA,Innovate Medical Center,3rd floor,Near YSR Statue,Ayyappa Socirty,Hyderabad,Telangana State -500081,India Hyderabad TELANGANA	8897455559 dachepallisunil@gmail.com
Dr Sidhartha samal	Institute of Medical Sciences and SUM Hospital,	Department of Clinical Research, Room No. NA,Institute of Medical Sciences and SUM Hospital, K-8, Kalinga Nagar, Ghatikia, Bhubaneswar 751003, Odisha. India Khordha ORISSA	8800163178 sidhusamal46@gmail.com
Dr Smruti Ramteke	Jasleen Hospital	Department of Clinical Research, Room No. NA, Opp to Big Bazar, Panchasheel Square, Dhantoli, Nagpur 440012, Maharashtra, India Mumbai (Suburban) MAHARASHTRA	9823514680 sramteke@rediffmail.com
Dr Ajay Dombale	Jivanrekha Multispecialty Hospital	Department of Clinical Research, Room No. NA,Sr No 28, Prabhu Complex,Dehuroad, Pune Sr No 28, Opp. Republic School, Dehuroad, Pune Pune Pune Maharashtra - 412101 India Pune MAHARASHTRA	7741810820 drajay9582@gmail.com
Dr Jigar Modia	Jupiter Hospital	Department of Clinical Research, Room No. NA, Sunpharma, Atladara Rd, opposite ICAI Bhavan, Atladara, Vadodara, 390012, Gujarat, India. Vadodara GUJARAT	9913041639 jigarmodia@gmail.com
Dr Sumanyu Kumar Tripathy	Kalinga Institute of Medical Sciences	Department of Clinical Research, Room No. NA,Kushabhadra Campus(KIIT Campus-5), Patia Bhubaneswar 757024, Odisha, india Khordha ORISSA	8093487271 sumanyu.tripathy@kims.ac.in
Dr Siddarth Pigilam	KIMS Icon Hospital	Department of Clinical Research, Room No. NA, D. No. 32-11-02 Sheelanagar, BHPV Post Visakhapatnam, Visakhapatnam Andhra Pradesh - 530012. Visakhapatnam ANDHRA PRADESH	988289998 sids9090@gmail.com
DrHarshad Joshi	Kiran Multi Super Speciality Hospital & Research Centre	Department of Clinical Research, Room No.NA,Vasta Devdi Road, near Sumul Dairy Road, Katargam, Surat, Gujarat 395004 Surat GUJARAT	9998992121 Harshad.Joshi@kiranhospital.com
Dr Shailesh Udapudi	KLES Dr. Prabhakar Kore Hospital & Medical Research Centre	Department of Clinical Research,Room No.N/A,KLES Dr. Prabhakar Kore Hospital & M.R.C, NH Service Road, Basava Circle, Chikodi, Nehru Nagar Belgaum, Karnataka 590010 Belgaum KARNATAKA	9844032434 drsvudapudi@gmail.com
Dr K sudhir reddy	Landmark Hospitals	Department of Clinical Research, Room No. NA,Near JNTU Metro Station,Opp Vasantha Nagar arch,Hydernagar Main Road,Kukatpally,Hyderabad-500085,Telangana state,India Hyderabad TELANGANA	9866939188 dcrlandmarkhospital@gmail.com
Dr Hiren Shah	Life-Line Multispeciality Hospital	Department of Clinical Research, Room No. NA,1st floor, shreenathji complex, Rander road opp jhulelal Temple, Ramnagar char rasta, Surat-395005 Surat GUJARAT	9879513814 hirenvshah25@gmail.com
Dr Hrishikesh Patkar	Lifepoint Multispeciality Hospital	Department of Clinical Research, Room No.145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune - 411057, Maharashtra, India Pune MAHARASHTRA	9011267776 patkarhrishikesh9@gmail.com
Dr Jenish Patel	Lotus Multispeciality Hospital	Department of Clinical Research, Room No. NA,2nd floor, N Block krupa residency, beside swastic school, Motera, Ahmedabad- 380005 Gujarat, India Ahmadabad GUJARAT	8000212142 jenis123@gmail.com
Dr Alok Kumar Kalyani	Maharaja Agresen Hospital	Department of Clinical Research, Room No. NA,Department of Rheumatology, Maharaja Agrasen Hospital, West Punjabi Bagh, New Delhi-110026. New Delhi DELHI	9540946955 alokkalyani@gmail.com
Dr Vishal Patil	Medipoint Hospitals Pvt. Ltd	Department of Clinical Research, Room No. NA, New D.P.Road, Near Sai Heritage, Aundh Pune Maharashtra - 411007 India Pune MAHARASHTRA	9405431728 drvishalpatil.pentagon@gmail.com
Dr Manju Adithya Nayak Sreenivas	Medstar Speciality Hospital	Department of Clinical Research, Room No. NA,Second floor, #641 I 17 I l13, Kodigehalli Main Road, Sahakarnagar, Bangalore- 560092, Karnataka, India. Bangalore KARNATAKA	9035362352 dradithyamedstar@gmail.com
Dr Mohan M R	Nano Hospital	Department of Clinical Research,Room No.No #79 Sir M. Visvesvaraya Road, Off, Bannerghatta Main Rd, Hulimavu, near Arekere, Bangalore-560076, Karnataka Bangalore KARNATAKA	9686567555 mohan_ortho@yahoo.com
DrNishil Shah	Nirmal Hospital Pvt. Ltd.	Department of Clinical Research,Room NO.NA,Nirmal Hospital Pvt Ltd, Ring Road, Surat, Guiarat -395002, India. Surat GUJARAT	9099925983 arnish002@gmail.com
DrSushil Mankar	NKP Sale institute of medical Science & research centre, Lata Mangeshkar Hospital	Department of Clinical Research, Room No. NA,olice Nagar CRPF Rd, Digdoh Hills, Police Nagar, Nagpur, Maharashtra 440019 Nagpur MAHARASHTRA	9422108284 drshmankar@gmail.com
Dr Shailesh Sheshrao Patil	Noble Hospital	Department of Clinical Research, Room No.153, Magarpatta City Road, Hadapsar- 411013, Pune, Maharastra India Pune MAHARASHTRA	9766530892 shaileshpatil123@gmail.com
Dr Srinivas Nagendra G	NRR Hospital	Department of Clinical Research, Room No.No.3&3A, Hesarghatta Main Road, Chikkasandra, Next to Janapriya Apartments, Near Chikkabanavara Railway Station, Bangalore-560 090. Bangalore KARNATAKA	9886627611 info@nrrhospital.com
Dr Govind Purohit	Orthocare Hospital	Department of Clinical Research, Room No. NA, 30, Shankar Soc.-1, Mirambika road, Nr. Naranpura post office, Naranpura, Ahmedabad-380014 Ahmadabad GUJARAT	8377953221 purohit86@yahoo.co.in
Dr Mehul Panchal	Pagarav Hospital & ICU	Department of Clinical Research, Room No. NA,Pagarav Hospital & ICU, Plot No 51211, Nr G6 Circle, Opp. SBI Sector-23, Gandhinagar-382023, Gujarat, India Gandhinagar GUJARAT	9920680506 doc8410@gmail.com
Dr Vinchhi Pratik Jitendrakumar	Parth Orthopedic & Surgical Hospital	Department of Clinical Research, Room No. NA,El 402, E l 405 -4,407 -41 l, Fourth Floor Galaxy Arcade,Near Galaxy Cinema, Naroda, Gujarat 382330, lndia Narmada GUJARAT	9909032354 pratikdevanshzarana@gmail.com
Dr Prashant Tonape	PDEAS Ayurved Rugnalay & Sterling Multispeciality hospital	Department of Clinical Research, Room No. NA,Sector no. 27, Behind Sweet Junction, Pradhikaran, Nigdi, Pune 411044 Pune MAHARASHTRA	9850133323 prashanttonape@gmail.com
Dr Anurag Chandrakar	PULSE HOSPITAL	Department of Clinical Research, Room No. NA, Pulse Hospital, 2/4, Nehru Nagar (W), Near Gurudwara, Bhilai- 490020 Durg CHHATTISGARH	7038901700 dranurag0009@gmail.com
DrJagjeet Nimbalkar	Pulse Multispeciality Hospital	Department of Clinical Research, Room No. NA,Vishwa Arcade Mumbai Bangalore HighwayÂ Narhe Pune 411041. Pune MAHARASHTRA	8780061100 drjagjeetnnimbalkar.pulse@gmail.com
Dr Anoop Khandelwal	Raneshwar Hospital	Department of Clinical Research,Room No.A-4 Parshaw Nagar Society Vasna Road Before Vasna, Ravi Park Society, Saiyed Vasna, Vadodara-390015, Gujarat, India Vadodara GUJARAT	9727767712 raneshwar.hospital@gmail.com
Dr Ramesh Ranka	Ranka Hospital	Department of Clinical Research, Room No. NA, Ranka Hospital, 157 / 5, SS Dhage Rd, near Swargate, Mukund Nagar, Pune-411037 Pune MAHARASHTRA	9823049074 rameshranka@yahoo.co.in
DrKoteshwara Prasad	Renova Neelima Hospital	Department of Clinical Research, Room No. NA,Voltas company Pvt Ltd, Opp:, 7-2-1735, Sanath Nagar Main Rd, Sanath Nagar, Hyderabad, Telangana 500018 Hyderabad TELANGANA	9880299099 dr-neelimahospital@gmail.com
Dr Chirag Thakkar	Rhythm Heart Institute	Department of Clinical Research,Room No.N/A,Rhythm Heart Institute- A Unit of SLPL Near Siddharth Bunglows, Sama- Savli Road, Vadodara- 390022 Gujarat Vadodara GUJARAT	9898265691 drcvtcr@gmail.com
Dr Chirag Thakkar	Rhythm Heart Institute	Department of Clinical Research, Room No. NA, Near Siddharth Bunglows Sama- Savli Road, Vadodara Gujarat-390022 India Vadodara GUJARAT	9898265691 drcvtcr@gmail.com
Dr Rahul Katta	S. R. Kalla Memorial Gastro & General Hospital	Department of Clinical Research, Room No. 78-79, Dhuleshwar Garden, Behind HSBC Bank, Sardar Patel Marg, C-Scheme-302001 Jaipur RAJASTHAN	9829010490 rahulkatta@hotmail.com
Dr Rahul Katta	S. R. Kalla Memorial Gastro & General Hospital	Department of Clinical Research, Room No. NA,8-79, Dhuleshwar Garden, Behind HSBC Bank, Sardar Patel Marg, C-Scheme, Jaipur - 302001, Rajasthan, India Jaipur RAJASTHAN	9829010490 rahulkatta@hotmail.com
Dr Tapan Shah	Sangini Hospital	Department of Clinical Research, Room No. NA, 1st Floor, Santorini Square, B/H Abhishree Complex,Opp. Star Bazar Lane, Satellite â€“ 380015 Ahmadabad GUJARAT	9825739241 drtapanshah@gmail.com
Dr Kalpesh Ashokkumar Mehta	Sanjivani Superspeciality Hospital Pvt.Ltd.	Department of Clinical Research, Room No. 1, Uday park Society, Nr. Sunrise Park, Vastrapur-380015 Ahmadabad GUJARAT	9879517351 drkalpesh2015@gmail.com
Dr Santosh Saklecha	Santosh Hospital	Santosh Hospital,6/1 PROMENADE ROAD- 560005 Bangalore KARNATAKA	9845306703 ssaklecha@gmail.com
Dr Sachin Dhote	Saraswati Kidney Care centre	Department of Clinical Research, Room No. NA, Saraswati Kidney Care Center, 13, New Sneh Nagar, Near Jaiprakash Nagar, Metro Station, Jaitala, Nagpur-440015, Maharashtra- India Nagpur MAHARASHTRA	9850853253 sachindhote123@gmail.com
Dr Chirag Patel	Shakti superpeciality Hospital & Research centre	Department of Clinical Research, Room No.A/108, 1st Floor, Krishna Complex, Nr. Shahwadi Bus Stand, NH-8, Narol-382405, Ahmedabad, Gujarat, India Ahmadabad GUJARAT	8377953221 drchirag4243@gmail.com
Dr Shailesh Talele	Shree Ashirwad Hospital	Department of Clinical Research, Room No. NA,C/3 Shree Complex Opposite Mahavir Road,Manpada Road Dombivli Thane Thane MAHARASHTRA	9819800196 shaileshtalele@yahoo.co.in
Dr Pooja Khosla	Sir Ganga Ram Hospital	Department of Medicine,Sir Ganga Ram Hospital Marg,Rajinder Nagar,New Delhi-110060,India New Delhi DELHI	9818288194 drpoojakhosla@yahoo.com
Dr Nirav Trivedi	Smt S.M.S Multispeciality Hospital,	Department of Clinical Research, Room No. NA,Dr. M K SHAH MEDICAL COLLEGE AND RESEARCH CENTRE, Near Tapovan Circle Visat Gandhinagar Higway, Chandkheda ahmedabad Ahmedabad Gujarat - 382424 Ahmadabad GUJARAT	7573949408 cxcr.sms@gmail.com
Dr Atul Garg	Sri Balaji Action Institute	Department of Clinical Research, Room No. NA,Sri Balaji Action Institute A-4 ,Paschim Vihar ,Delhi-110063 East DELHI	9873334056 drgargatul01@gmail.com
DrAjay Krishnan	Stavya Spine Hospital & Research Institute Pvt. Ltd.	Department of Clinical Research, Room No. NA,2nd floor, Stavya Spine Hospital & Research Institute Pvt. Ltd, Near Nagari Eye Hospital, Mithakhali, Ahmedabad-380006 Ahmadabad GUJARAT	9824302768 drajaykrishnan@gmail.com
Dr M Narendra	Sunrise Hospitals	Department of Clinical Research, Room No. NA, Sunrise Hospitals, Opp Corporation bank, Near Pushpa Hotel Centre, Bellapu Shobhanadri Road, Suryaraopet, Vijaywada- 520002 Krishna ANDHRA PRADESH	9848113561 narendrasunrise1@gmail.com
Dr Suneet Rajshekhar	Suraaj Hospital	Department of Clinical Research, Room No. NA,Suraaj Hospital, Bhilai, 4 B/2 Nehru Nagar west- 490020 Durg CHHATTISGARH	9981712998 suneet.rajshekhar@gmail.com
Dr Rohit Sonawane	SuryaÂ MultispecialityÂ Hospital	Department of Clinical Research, Room No. NA, SuryaÂ MultispecialityÂ Hospital ,Nashik,Â Â Maharashtra 422003Â Â Surya Multisepiciality Hospital,Surya arcade, 2nd floor, opp. Nimani Bus stand, Panchvati, Nasik- 422003 Nashik MAHARASHTRA	9225109679 srgnosteon@gmail.com
DrAmit Patel	Unity Hospital	Department of Clinical Research, Room No. NA,Unity hospital, Nr.DR ,Opp Raghuvir Business Empire, Aai Mata Road, Parvat Patiya, Surat 395010, Gujarat ,India Surat GUJARAT	9374077567 dramitpatelortho@gmail.com
DrSadik Shaikh	Unity Ortho Care	Department of Clinical Research, Room No. NA,Beside Sejal hospital,Kadodra -Bardoli road,kadodra-Bardoli Char rasta,Surat-394327,Gujarat,India Surat GUJARAT	9825681012 drshaikhsadik@gmail.com
Dr Dhaiwat Shukla	V S General Hospital	Department of Clinical Research,Room No.NA,Ellisbridge, Ahmedabad-380006, Gujarat, India Ahmadabad GUJARAT	8980024107 dr.dhaiwatshukla89@gmail.com
DrNilesh Pitamber Patil	Vedant Multispeciality Hospital	Department of Clinical Research, Room No. NA,Plot No.GP83,G Block,MIDC,Sambhajinagar,Chinhwad,Pune-411019 Pune MAHARASHTRA	7720005912 drnileshpatil.vedant@gmail.com
DrVrajesh Shah	Viroc Hospital	Department of Clinical Research, Room No NA,Viroc Hospital, Arya Kanya Rd, opposite Lohana Samaj Seva Mandal, Karelibagh, Vadodara, Gujarat 390018 Vadodara GUJARAT	9227473101 drvrspi@gmail.com
Dr Yogesh Sisodiya	Vishwaraj Hospital	Department of Clinical Research, Room No. NA, Vishwaraj Hospital Gate No.499, Kadamwakwasti Solapur Road Loni Kalbhor Pune-412201 Maharashtra Pune MAHARASHTRA	7710904144 yogeshsportsdoc@gmail.com
DrBharat Mody	Wel Care hospital	Department of Clinical Research, Room No NA,Vadsar Rd, Near Mercedes showroom, Atladara, Vadodara, Gujarat 390012 Vadodara GUJARAT	9824036065 ceo@welcarehospital.co.in

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 75
Name of Committee	Approval Status
Ethics Committee Prime Hospitals, Dr G Sathish Reddy	Approved
Aakash Healthcare Institutional Ethics Committee, Dr. Ashish Chaudhry	Approved
Altezza Institutional Ethics Committee, Dr. Pritish Khardikar	Approved
Altezza Institutional Ethics Committee, Dr. Shailesh Talele	Approved
Anand Institutional Ethics Committee, Dr. Jigar Modia	Approved
Anand Institutional Ethics Committee, Dr.Vrajesh Shah	Approved
Anand Surgical Hospital IEC, Dr. Rishi Sanghavi	Approved
Ananta Institutional Ethics Committee, Dr. Manish Sumer Singh	Approved
Asopa Ethics Committee, Dr. Arvind Asopa	Approved
B J Medical College and Civil Hospital Office of the Medical Superintendent, Dr. Kaushal Ramanlal Anand	Submittted/Under Review
CLINISYD Research Global Solutions Pvt Ltd, Dr. Srinivas Nagendra G	Approved
Dhanvantri Ethical Committee for Human Research, Dr. R P Saini	Approved
DR B L KAPUR MEMORIAL HOSPITAL ETHICS COMMITTEE, Dr. Rakesh Mahajan	Approved
Ethics Committee , Landmark Hospitals, Dr. K sudhir reddy	Approved
Ethics Committee , Landmark Hospitals, Dr.Sunil Dachepalli	Approved
Ethics Committee of Pulse Multispecialty Hospital, Dr.Â Jagjeet Nimbalkar	Approved
Ethics Committee Sterling Multispeciality hospital, Dr. Prashant Tonape	Approved
Global Ethics Committee, Dr. Yogesh Kathiriya	Approved
Help Hospitals Private Limited, Dr. K.V. Satyanarayana	Approved
I E C ADITYA MULTI SPECIALITY HOSPITAL, Dr. P. Krishna Saravanth	Approved
IEC - Asian Education & Research Foundation Ahmedabad Bariatrics & Cosmetics Pvt Ltd., Dr. Sharad Purohit	Approved
IEC Endolife Speciality Hospital, Dr. Krishna Chaitanya	Approved
IEC IMS and SUM Hospital, Dr. Sidhartha samal	Approved
IEC Maeers Vishwaraj Hospital, Dr. Yogesh Sisodiya	Approved
IEC-Sai Sneh Hospital and Diagnostic Centre, Dr. Girish Bhatia	Approved
IEC-Vedant Multispeciality Hospital, Dr.Nilesh Pitamber Patil	Approved
Imperial Hospital Ethics Committee, Dr.Sachin Gupta	Approved
Inst. Ethics Committee of KLE, Shailesh Udapudi	Approved
Institutional Ethics Committee - CRICR, Dr.Chandrasekhar Srikhantaiah	Approved
Institutional Ethics Committee KIMS Icon Hospital, Dr. Siddarth Pigilam	Approved
Institutional Ethics Committee Sunrise Hospital, Dr. M. Narendra	Approved
Institutional Ethics Committee, Dr. Aman Khanna	Approved
Institutional Ethics Committee, Dr. Deepak RainaÂ	Approved
Institutional Ethics Committee, Dr. Nirav Trivedi	Approved
Institutional Ethics Committee, Dr. Saurabh Sah	Approved
Institutional Ethics Committee, Dr.Koteshwara Prasad	Approved
Institutional Ethics Committee, Dr.Sushil Mankar	Approved
Institutional Ethics Committee- Pulse Hospital, Dr. Anurag Chandrakar	Approved
Institutional Ethics Committee- Pulse Hospital, Dr. Anurag Chandrakar	Approved
Institutional Ethics Committee- Pulse Hospital, Dr. Suneet Rajshekhar	Approved
Institutional Ethics Committee-KIMS, Dr. Sumanyu Kumar Tripathy	Submittted/Under Review
Jasleen Hospital Ethics Committee, Dr. Smruti Ramteke	Submittted/Under Review
Jivanrekha Institutional Ethics Committee, Dr. Ajay Dombale	Approved
Jivanrekha Institutional Ethics Committee, Dr. Ramesh Ranka	Approved
Kiran Hospital Ethics Committee, Dr Harshad Joshi	Approved
Lotus Ethics Committee, Dr. Jenish Patel	Approved
LPR Ethics Committee, Dr. Hrishikesh Patkar	Approved
Magna-care Ethics Committee, Dr. Naisar Dilip Nahar	Approved
Maharaja Agrasen Hospital Institutional Ethics Committee, Dr. Alok Kumar Kalyani	Approved
Medstar Speciality Hospital Ethics Committee, Dr. Manju Adithya Nayak Sreenivas	Approved
Muktai Hospital Institutional Ethics Committee, Dr Rohit Sonawane	Approved
Nirmal Hospital Ethics Committee, Dr. Hiren Shah	Approved
NIRMAL HOSPITAL ETHICS COMMITTEE, Dr.Nishil Shah	Approved
Noble Hospital Institutional Ethics Committee, Dr. Shailesh Sheshrao Patil	Approved
Pagarav Ethics Committee, Dr. Mehul Panchal	Approved
Parth Hospital Ethics Committee, Dr. Vinchhi Pratik Jitendrakumar	Approved
Penta-Med Ethics Committee, Dr. Vishal Patil	Approved
Raneshawar Multispeciality Hospital, Dr.Bharat Mody	Approved
Raneshawar Multispeciality Hospital,Dr. Anoop Khandelwal	Approved
Rhythm Heart Institute Ethics Committee,Dr. Chirag Thakkar	Approved
Riddhi Medical Nursing Home IEC, Dr. Dhaiwat Shukla	Approved
S.R.Kalla Memorial Ethics Committee for Human Research, Dr. Rahul Katta	Approved
Sangini Hospital Ethics Committee, Dr Tapan Shah	Approved
Sangini Hospital Ethics Committee,Dr. Hardik Shah	Approved
Sanjivni Hospital Ethics Committee, Dr. Kalpesh Ashokkumar Mehta	Approved
SANTOSH HOSPITAL-INSTITUTIONAL ETHICS COMMITTEE, Dr. Santosh Saklecha	Approved
Sir Ganga Ram Hospital Ethics Committee, Dr. Pooja Khosla	Submittted/Under Review
Sri Balaji Action Medical Institute Ethics Committee, Dr. Atul Garg	Approved
Sri Durgamba Independent Ethics Committee, Dr Mohan M R	Approved
Stavya Spine & Research Institute Institutional Ethics Committee, Dr.Ajay Krishnan	Approved
Triveni Polyclinic Institutional Ethics committee, Dr. Sachin Dhote	Submittted/Under Review
Unity Hospital Ethics Committee, Dr.Amit Patel	Approved
Unity Hospital Ethics Committee, Dr.Sadik Shaikh	Approved
Vrajesh Hospital Institutional Review Board,Dr Govind Purohit	Approved
Vrajesh Hospital, Institutional Review Board, Dr. Chirag Patel	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
Intervention	Denosumab 60 mg/mL Solution for injection in single-use prefilled syringe	Manufacturer- Intas Pharmaceuticals Ltd., India; Dosage Level- 60 mg once every 6 months; Route of Administration- Subcutaneous injection
Comparator Agent	ProliaÂ® 60 mg/mL Solution for injection in single-use prefilled syringe	Manufacturer- Amgen Europe B.V. (EU-licensed product); Dosage Level- 60 mg once every 6 months; Route of Administration- Subcutaneous injection

Inclusion Criteria

Age From	55.00 Year(s)
Age To	90.00 Year(s)
Gender	Female
Details	1. Participant must sign an ICF to participate in the study indicating that she understands the purpose of, and procedures required for the study as described in this protocol and is willing to and will be able to adhere to requirement of the protocol. 2. Participant must be 55 to 90 years of age (both inclusive), at the time of signing the informed consent. 3. Participants who are medically/clinically stable on the basis of physical examination, medical history, vital signs, chest x-ray PA view, 12-lead ECG and clinical laboratory parameters performed at screening. Any abnormalities or deviation from normal, must be consistent with the underlying illness in the study population and judged by investigator to be not clinically significant. This determination must be recorded in the participants source documents and initialed by the investigator. 4. Participants whose absolute bone mineral density T-score is less than equal to -2.5 and greater than equal -4.0 at the lumbar spine as measured by DXA (dual-energy x-ray absorptiometry), confirmed by the independent central imaging team 5. At least two vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA, confirmed by the independent central imaging team 6. Body weight between 50 kg and 90 kg (both inclusive) at screening. 7. Postmenopausal ambulatory female and not considered to be of child-bearing potential if: a. Women are considered post-menopausal and not of child-bearing potential if, i. They have had 12 months of natural (spontaneous) amenorrhea (no vaginal bleeding or spotting) with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) OR ii. Six months of spontaneous amenorrhea with serum FSH levels greater than 40 mIU per mL OR iii. Have had surgical bilateral oophorectomy (with or without hysterectomy) at least six months ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment if she is considered not of child-bearing potential.

ExclusionCriteria

Details

1. Documented medical history of clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
2. Documented medical history of known allergies, hypersensitivity, or intolerance to denosumab or its excipients (refer to the IB)
3. History of any prior use of denosumab
4. Documented medical history of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as Pagets disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, rheumatoid arthritis, ankylosing spondylitis or any other joint disease limiting mobility, Cushings disease, hyperprolactinemia, malabsorption syndrome
5. Documented medical history of latex or dry natural rubber allergy
6. Contraindications to the use of denosumab or Vitamin D and Calcium as per IB/local prescribing information at screening and/or baseline
7. Documented medical history and/or current evidence of any of the following oral/dental conditions
a. Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw.
b. Active dental or jaw condition which requires oral surgery.
c. Planned invasive dental procedure expected during study period.
d. Current evidence non-healed dental or oral surgery.
e. Current evidence of poor oral hygiene
f. Ill-fitting denture
8. Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range at screening. Serum calcium levels may be retested once in case of an elevated/low serum calcium level as assessed by the clinical laboratory. Final decision to include the patient based on the risk of hypocalcemia to be taken by the Investigator.
9. History of frequent occurrence of hypocalcemia, history of severe hypocalcemia or presence of diseases that can precipitate hypocalcemia frequently (like malabsorption syndromes (for example celiac disease, history of excision of small intestine etc.) and severe renal impairment)
10. Current, uncontrolled hyper- or hypoparathyroidism and history of hypoparathyroidism, per participant report or chart review. PTH outside the normal range (15-65 pg/mL) as assessed by central laboratory
11. Current, uncontrolled hyper- or hypothyroidism, defined as thyroid stimulating hormone outside of the normal range (TSH-0.465 to 4.68 mIU/L) at screening.
12. 25 (OH) Vitamin D lower than 20 ng/mL as assessed by the central laboratory at Screening. Vitamin D repletion will be permitted, and participants may be rescreened once.
13. History of external beam or implant radiation therapy involving the skeleton.
14. History and /or presence of 1 severe fracture or 2 moderate vertebral fractures
15. Patients with bone metastases or a history of malignancies affecting bones.
16. Smokers or who have smoked within last 06 months prior to start of the study.
17. Documented medical history of major surgery, (e.g. requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study.
Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate.
18. Documented medical history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
19. Documented medical history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening.
20. Documented medical history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 1 year before Screening
21. Lymphoma, leukemia, or any malignancy (current or suspected) within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; carcinoma in situ of the cervix; or malignancy, which is considered cured with minimal risk of recurrence
22. QTc interval Greater than 470 msec or QT interval Greater than 480 msec in participants with bundle branch block.

Note: The QTc is the QT interval corrected for heart rate according to Bazetts formula (QTcB). It is either machine-read or manually over-read.
23. Administration of bisphosphonate as follows: -
c. IV Bisphosphonate in the past 3 years
d. Oral bisphosphonates treatment for osteoporosis
i. More than 3 years of cumulative use
ii. Any dose received within 6 months prior to randomization
iii. More than 1 month of cumulative use between 6 and 12 months prior to randomization
24. Teriparatide or any PTH analogs treatment received within 12 months prior to randomization.
25. Systemic oral or transdermal estrogen, SERMs, or calcitonin treatment of more than 1 month of cumulative use within 6 months prior to randomization.
26. Androgen deprivation or hormonal ablation therapy of more than 1 month of cumulative use within 6 months prior to randomization.
27. Tibolone or cinacalcet treatment received within 3 months prior to randomization
28. Systemic glucocorticoids: Greater than equal to 5 mg prednisone equivalent per day for more than 10 days within 3 months prior to randomization.
29. Abnormal laboratory values
a. General: Any laboratory 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.
b. Liver transaminases:

i. Serum aspartate aminotransferase (AST) Greater than equal to3.0 in to upper limit of normal (ULN)
ii. Serum alanine aminotransferase (ALT) Greater than equal to 3.0 in to ULN

c. Alkaline phosphatase and bilirubin Greater than equal to 1.5 in to ULN
d. Creatinine clearance estimated using Cockcroft Gault formula is less than30 mL/min
30. Taken any prohibited therapies as noted in Section 6.8, Concomitant Therapy before the planned first dose of study IMP
31. Received any investigational IMP 30 days or 5 half-lives (whichever is longer) before the signing the consent or is currently enrolled in an investigational study
32. Unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. This includes but is not limited to hepatitis virus infections, drug- or alcohol-related liver disease, non-alcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilsons disease, alpha-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the investigator.
Note: Stable chronic liver disease (including Gilberts syndrome, asymptomatic gallstones) is acceptable if the participant otherwise meets entry criteria.
33. Any other clinical/social/ psychiatric condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
34. Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site

NOTE: Investigators should ensure that all study enrollment criteria have been met at screening. If a participants clinical status changes (including any available laboratory results or receipt of additional medical records) after screening but before the first dose of study IMP is given such that he or she no longer meets all eligibility criteria, then the participant should be excluded from participation in the study.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
- To compare the pharmacokinetic parameters of denosumab and denosumab-ref in postmenopausal women with osteoporosis. - To compare the pharmacodynamic effect of treatment with denosumab and denosumab-ref on bone mineral density (BMD) and bone resorption marker in postmenopausal women with osteoporosis	- Pharmacokinetics: Cmax, AUC0-t, and AUC0-infinity after first dose of denosumab and denosumab-ref - Mean percentage change in BMD at lumbar spine from baseline to 12 months between denosumab and denosumab-ref - Pharmacodynamics: Emax and AUEC0-t of % reduction from baseline serum C-terminal telopeptide (CTX) after first dose of denosumab and denosumab-ref

Secondary Outcome

Outcome	TimePoints
To compare the efficacy of treatment with denosumab and denosumab-ref in postmenopausal women with osteoporosis	Incidence of clinical fracture between denosumab and denosumab-ref over 12 months.
To compare the pharmacodynamic effects of the treatment with denosumab and denosumab-ref in postmenopausal women with osteoporosis	Mean percentage change in bone mineral density (BMD) of lumbar spine from baseline to 06 months between denosumab and denosumab-ref
To compare the immunogenicity of denosumab and denosumab-ref in postmenopausal women with osteoporosis	Incidence of anti-denosumab antibody in denosumab and denosumab-ref arm over 12 months

Target Sample Size

Total Sample Size="552"
Sample Size from India="552"
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 3

Date of First Enrollment (India)

13/09/2021

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="4"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

None

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary

This is a randomized, double-blind, active-controlled, parallel-arm, multicenter study comparing the pharmacokinetics, pharmacodynamics, and immunogenicity of Denosumab of Intas (60 mg/ml) with Prolia, in postmenopausal women with osteoporosis aged 55 to 90 years, both inclusive.