CTRI/2024/03/064638 [Registered on: 21/03/2024] Trial Registered Prospectively
Last Modified On:
31/10/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Single Arm Study
Public Title of Study
A prospective phase IV studyto evaluate safety and efficacy profile of DenosteRel® in post-menopausal women with osteoporosis
Scientific Title of Study
A prospective, multi-centre, open label, phase IV study
to evaluate safety and efficacy profile of DenosteRel® in
post-menopausal women with osteoporosis
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
RLS/PMS/2022/06; Version 1.0, Dated: 01 Feb 2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ajaykumar Yadav
Designation
AVP and head Clinical Research
Affiliation
Reliance Life Sciences Pvt. Ltd. (RLS)
Address
Reliance Life Sciences Pvt. Ltd. (RLS), Dhirubhai Ambani Life Sciences Centre
(DALC)R-282, TTC Area ofMIDC, Thane - Belapur Road, Rabale, Navi
Mumba
Thane MAHARASHTRA 400701 India
Phone
9820804218
Fax
Email
Ajaykumar2.Yadav@relbio.com
Details of Contact Person Scientific Query
Name
Dr Sachin Kagane
Designation
Medical Monitor
Affiliation
Reliance Life Sciences Pvt. Ltd. (RLS)
Address
Reliance Life Sciences Pvt. Ltd. (RLS), Dhirubhai Ambani Life Sciences Centre
(DALC)R-282, TTC Area ofMIDC, Thane - Belapur Road, Rabale, Navi
Mumba
Thane MAHARASHTRA 400701 India
Phone
9987885679
Fax
Email
Sachin.Kagane@relbio.com
Details of Contact Person Public Query
Name
Pratap Misal
Designation
Project Manager
Affiliation
Reliance Life Sciences Pvt. Ltd. (RLS)
Address
Reliance Life Sciences Pvt. Ltd. (RLS), Dhirubhai Ambani Life Sciences Centre
(DALC)R-282, TTC Area ofMIDC, Thane - Belapur Road, Rabale, Navi
Mumba
Thane MAHARASHTRA 400701 India
Phone
8169319741
Fax
Email
Pratap.Misal@relbio.com
Source of Monetary or Material Support
Reliance Life Sciences Pvt Ltd (RLS) Dhirubhai Ambani Life Sciences Centre (DALC) R-282, TTC Area of MIDC, Thane - Belapur Road,
Rabale, Navi Mumbai - 400701,India
Primary Sponsor
Name
Reliance Life Sciences Pvt Ltd RLS
Address
Reliance Life Sciences Pvt Ltd (RLS) Dhirubhai Ambani Life Sciences Centre (DALC) R-282, TTC Area of MIDC, Thane - Belapur Road,
Rabale, Navi Mumbai - 400701,India
AIIMS, Bhubaneswar, sujaa,Poatrapada,Po-Dumduma-751019, Odisha, India Khordha ORISSA
9438884203
sujiankita@gmail.com
Dr Vishnu Sharma
Amber clinic
401-402, 4th Floor, Santorini Square, Opp Star Bazar, behind Abhishree complex, Near Jodhpur Cross Rd, Satellite road, Ahmedabad – 380015, Gujarat, India Ahmadabad GUJARAT
8511555477
drvishnusharma@yahoo.co.in
Dr Somesh Singh
BJ Medical college and civil hospital
New Civil Hospital, Asarwa, Ahmedabad 380016, Gujrat, India Ahmadabad GUJARAT
9825370446
drsomeshsingh@yahoo.com
Dr V Krishnamurthy
Chennai meenakshi multispeciality hospital limited
Chennai meenakshi multispeciality hospital limited, old 149, New 70, Luz Church road, mylapore, chennai 600004, Tamil Nadu, India
Chennai TAMIL NADU
9841041717
drvk56@gmail.com
Dr Manish Kulkarni
Dhanwantari Hospital
Dhanwantari Hospital, 339-c, Rasta Peth, Pune-411011, Maharashtra, India Pune MAHARASHTRA
7219602022
drmanishk@dhanwantaripune.com
Dr Bhavesh Jesalpura
GMERS Medical College and Civil Hospital
GMERS Medical College and Civil Hospital Sola, Nr Gujrat Highcourt, S.G. Highway, Sola, Ahmedabad, 380061, Gujrat, India. Ahmadabad GUJARAT
9033023000
bjesalpura@yahoo.com
Dr Rohit Nath
GSVM Medical College
Department of Orthopedics, GSVM Medical College, Near Rawatpur Crossing, Kanpur-208002, Uttar Pradesh, India Kanpur Nagar UTTAR PRADESH
8009984893
nath.ortho@gmail.com
Dr Arnab Karmakar
Institute of Post Graduate Medical Education & Research
Department of Orthopedics,
244 AJC Bose Road, Kolkata-700020, West
Bengal, India Kolkata WEST BENGAL
9830401377
arnab.doctor@gmail.com
Dr Tushar Chaudhari
K K Care Hospital
K K Care Hospital, Vadmukhvadi, Charholi Bk, Padmavati Nagari, Pune-412105, Maharashtra, india Pune MAHARASHTRA
9820818092
tushu253@gmail.com
Dr Vinod Kumar
KIMS Hospital & Research Center
B Block, Department of Orthopedics,OPD Building,
K. R. Road, V. V. Puram, Bangalore-56000, Karnataka, India Bangalore KARNATAKA
9886244455
vinodabbur@gmail.com
Dr Shah Waliullah
King George Medical University
4th Floor,Department of Orthopedics, King George Medical University, RALC Campus, Nabiulla Road,Lucknow,226018, Uttar Pradesh, India Lucknow UTTAR PRADESH
9335716350
Shahwali2008@gmail.com
Dr Kaushik Basu
Medical College and Hospital, Kolkata
Medical College and Hospital, 88 College Street, Kolkata 700073, West Bengal, India Kolkata WEST BENGAL
9038831211
phoenix.0013@gmail.com
Dr Rajesh Paraonis
Oyster & Pearl Hospitals
,1671-75,Ganeshkhind road ,shivajinagr ,pune,411005,Maharashtra India Pune MAHARASHTRA
9372416491
drrajeshp798@gmail.com
Dr M Javed Iqbal M Jaleel
Saikrupa Hospital
Room no: NA, Department: NA, Division: NA, Renuka Corner, Tapkir Chowk, Thergaon, Pune- 411033, Maharashtra, India Pune MAHARASHTRA
8308081314
drjavedresearch@gmail.com
Dr Sharad Purohit
Sanjivani Super Speciality Hospital Pvt. Ltd.
Clinical Research
Department, 1, Uday Park Society,Nr. Sunrise Park,
Vastrapur Ahmedabad-380015, Gujarat, India Ahmadabad GUJARAT
9879007908
dr_sharadpurohit@hotmail.com
Dr Jeet Patel
Shlok Superspeciality Care
Shlok Superspeciality Care, B/H Cresent Hotel Opp. Radhaswami Samyak, Lambhavel Road, Anand-411007, Gujarat, India Anand GUJARAT
Chennai meenakshi multispeciality hospital Ethics Committee
Approved
Ethics Committee S.M.S. Medical College and Attached HospitalsÂ
Approved
Ethics Committee Sir Ganga Ram HospitalÂ
Submittted/Under Review
Ethics Committee, GSVM Medical CollegeÂ
Approved
Institutional Ethics Committee
Approved
INSTITUTIONAL ETHICS COMMITTEE B.J. MEDICAL COLLEGE AND CIVIL HOSPITA
Submittted/Under Review
Institutional Ethics Committee for human research medical college and Hospital Â
Approved
Institutional Ethics Committee GMERS Medical college
Approved
Institutional Ethics Committee Shlok Superspecialty Care
Approved
INSTITUTIONAL ETHICS COMMITTEE, AlIMSÂ
Approved
Institutional ethics committeeÂ
Submittted/Under Review
IPGMEandR Resaerch Oversight CommitteeÂ
Submittted/Under Review
Jivanrekha Institutional Ethics Committee
Approved
KIMS Institutional Ethics CommitteeÂ
Approved
O&P institutional Ethics Committee
Approved
Saikrupa Hospital Institutional Ethics Committee
Approved
Sangini Hospital Ethics CommitteeÂ
Submittted/Under Review
Sanjivani Hospital Ethics Committee
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
DenosteRel®
Study drug Dose of 60 mg at baseline and at Month 6 (Day 1 & Day 180) by subcutaneous route for a total duration of 9 months
Comparator Agent
NA
NA
Inclusion Criteria
Age From
40.00 Year(s)
Age To
75.00 Year(s)
Gender
Female
Details
1.Postmenopausal ambulatory woman ≤75 years of age (post menopausal phase of 5 years or more).
2.Patients with BMD value consistent with a T-score between -2.5 to -4.0 at either lumbar spine or hip.
3.Able to understand the study procedures and the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
ExclusionCriteria
Details
1.Patients with any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings, Paget’s disease, Cushing’s disease or Hyperpolactinemia
2.Patients with severe, untreated hypocalcaemia or hypercalcemia
3.Patients with Vitamin D deficiency; Vitamin D supplements will be permitted and patient can be retested for Vitamin D.
4.Current hyperparathyroidism or hypoparathyroidism
5.Uncontrolled Hyperthyroidism or hypothyroidism except patients on stable thyroid hormone replacement therapy for last one year
6.Any clinical fracture within last 6 months prior to screening and/or any vertebral fracture on screening spinal X-ray
7.Prior use of Denosumab; hypersensitivity to the Denosumab or any of the excipients
8.Patients with prior history or current evidence of osteomyelitis or osteonecrosis of the jaw, active dental or jaw condition which requires oral surgery, planned invasive dental procedure or non-healed dental or oral surgery.
9.Received any solid organ or bone marrow transplant or on chronic immunosuppression for any reason
10.History of malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5-years.
11.Height, weight or girth that has a potential to preclude accurate DEXA measurements
13.Administration of fluoride (except for dental treatment), or strontium ranelate within last one year
14.Administration of IV bisphosphonate, cumulative use of oral bisphosphonates (≥ 1 month) within last 6 months; or any use of oral bisphosphonate within last 3 months ( except for the subset of 50 patients who will be enrolled based on treatment failure with bisphosphonate).
15.Administration of any of the following treatments within 6 weeks prior to screening: Anabolic steroid or testosterone, androgen deprivation therapy, parathyroid hormone analogue, calcitonin, calcitriol, vitamin D derivatives (Vitamin D contained in supplements or multivitamins will be permitted) or other bone active drugs including anticonvulsants and heparin
16.Chronic systemic ketoconazole, chronic systemic corticosteroid, ACTH, cinacalcet, aluminium, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists within 6 weeks prior to screening
17.History of Rheumatoid arthritis
18.History of malabsorption syndrome or any gastrointestinal disorders associated with malabsorption.
19.Patients who are HIV, HBsAg, HCV test positive.
20.History of alcohol or substance abuse within the last 12-months which the Investigator believes would interfere with understanding or completing the study.
21.History of myocardial infarction or stroke within 6 months prior to enrolment or any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: uncontrolled hypertension, unstable angina; congestive heart failure (≥ grade 2), cardiac arrhythmia, clinically significant peripheral vascular disease; uncontrolled diabetes
22.History or presence of any medical or psychiatric condition or disease, physical examination finding, clinical laboratory finding or any other condition that in the opinion of the Investigator, may place the patient at unacceptable risk for study participation or that might affect the interpretation of the results of the study or may prevent the patient from completing the study.
23.Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease that renders the patient incapable of participating in the study
24.Presence of active or uncontrolled infection, or history of serious infection which caused hospitalization within 6 months prior to enrolment or other severe or chronic infection (such as sepsis, abscess or opportunistic infections, invasive fungal infection such as histoplasmosis, or a history of recurrent herpes zoster or other chronic or recurrent infection) or a past diagnosis without sufficient documentation of complete resolution following treatment.
Participation in any clinical study of an investigational product within previous 3 months.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
To evaluate safety profile of DenosteRel® in postmenopausal women patients with
osteoporosis
AE & SAE Will be Captured at Day 1,Day 30 Day 90, Day 180, Day 270 & Withdrawal Visit
Secondary Outcome
Outcome
TimePoints
To evaluate efficacy profile of DenosteRel® in postmenopausal women patients with
osteoporosis
Percent change in BMD & T-score at lumbar spine & hip from baseline to month
6 & month 9
Percent change in BMD & T-score at distal radius from baseline to month 6 and
month 9
Incidence of vertebral & non-vertebral fractures at month 6 & month 9
Immunogenicity (Baseline & month 9)
Target Sample Size
Total Sample Size="233" Sample Size from India="233" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is prospective, multi-centre, open label, phase IV study to evaluate safety and efficacy profile of DenOsteoRelâ„¢. In this study, a total of 233 postmenopausal women patients with osteoporosis will be enrolled. Out of these 233 patients, a subset of 50 patients who have failed on Bisphosphonate therapy will be enrolled. For this subset of 50 patients only, section 6.2 exclusion criteria no. 14 will not be applicable. Informed consent will be obtained from the participating patients prior to any study specific activity following which patient will be enrolled in the study. Eligible subjects will receive DenOsteoRelâ„¢ at a recommended dose as per prescribing information. Patients will receive DenOsteoRelâ„¢as a single subcutaneous injection (60 mg) at baseline and at Month 6 as per prescribing information. Safety and efficacy evaluations will be performed from baseline to end of study visit (visit 6/ Month 9).