CTRI/2018/05/013924 [Registered on: 16/05/2018] Trial Registered Prospectively
Last Modified On:
26/11/2020
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Study in postmenopausal women with osteoporosis
Scientific Title of Study
Prospective, multicenter,randomized,double blind, two arm, parallel group, active control, comparative clinical study to evaluate efficacy and safety of R-TPR-045/Prolia in postmenopausal women with osteoporosis
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
RLS/OST/2016/05 V3 dated 21 Dec 2016
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Jamila Joseph
Designation
SVP-RLS Clinical Trial Group
Affiliation
Reliance Life Sciences Pvt Ltd.
Address
Dhirubhai Ambani Life Sciences Centre, Plot-R 282, TTC Area of MIDC, Thane Belapur Road, Rabale, Navi Mumbai-400701
Thane MAHARASHTRA 400701 India
Phone
Fax
Email
jamila.joseph@ril.com
Details of Contact Person Scientific Query
Name
Jamila Joseph
Designation
SVP-RLS Clinical Trial Group
Affiliation
Reliance Life Sciences Pvt Ltd.
Address
Dhirubhai Ambani Life Sciences Centre, Plot-R 282, TTC Area of MIDC, Thane Belapur Road, Rabale, Navi Mumbai-400701
MAHARASHTRA 400701 India
Phone
Fax
Email
jamila.joseph@ril.com
Details of Contact Person Public Query
Name
Ravikiran Payghan
Designation
Manager-RLS Clinical Trial Group
Affiliation
Reliance Life Sciences Pvt. Ltd.
Address
Dhirubhai Ambani Life Sciences Centre, Plot-R 282, TTC Area of MIDC, Thane Belapur Road, Rabale, Navi Mumbai-400701
Thane MAHARASHTRA 400701 India
Phone
Fax
Email
ravikiran.payghan@relbio.com
Source of Monetary or Material Support
Reliance Life Sciences Pvt. Ltd
Primary Sponsor
Name
Reliance Life Sciences Pvt Ltd
Address
Dhirubhai Ambani Life Sciences Centre
Plot R-282, TTC Area of MIDC
Thane Belapur Road
Rabale, Navi Mumbai 400 701
Manipal Academy of Higher Education Ethics Committee
Approved
Omega Ethical Committee
Approved
Sanjivani Hospital Ethics Committee
Approved
Sapthagiri Institute of Medical Sciences and Research Center Institutional Ethics Committee
Approved
Saviour Hospital Ethics Committee
Approved
Shree Giriraj Hospital Research Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Post-menopausal women with osteoporosis,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Prolia®
Denosumab 60 mg S.C. Injection every 6 months for 12 months
Intervention
R-TPR-045
Denosumab 60 mg S.C Injection every 6 months for 12 months
Inclusion Criteria
Age From
18.00 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, Paget’s disease, Cushing’s disease or Hyperprolactinemia
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. Received any solid organ or bone marrow transplant or on chronic immunosuppression for any reason
9.Height, weight or girth that has a potential to preclude accurate DXA measurements
10.Patient with severe renal impairment (creatine clearance <30 mL/min) or receiving dialysis.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Percent change in BMD and T-score at lumbar spine and hip
From Baseline to 12 months
Secondary Outcome
Outcome
TimePoints
To evaluate other efficacy parameters, pharmacokinetics, pharmacodynamics, safety and tolerability of R-TPR-045 / Prolia® (Denosumab)
From Baseline to 12 months
Target Sample Size
Total Sample Size="159" Sample Size from India="159" 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)?
Brief Summary
This will be a
prospective, multi-centre, double-blind, two-arm, parallel group, active
control, randomized comparative clinical study is being conducted to compare the efficacy and safety of R-TPR-045 and Prolia in post-menopausal women with osteoporosis.