Study in postmenopausal women with osteoporosis

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/05/013924
• Date of registration: 16-05-2018
• Prospective Registration: Yes
• Primary sponsor: Reliance Life Sciences Pvt Ltd
• Public title: Study in postmenopausal women with osteoporosis
• Scientific title: 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
• Date of first enrolment: 20-06-2018
• Target sample size: 159
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=23200
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Ravikiran Payghan
• Affiliation: Reliance Life Sciences Pvt Ltd.

• Name: Jamila Joseph
• Affiliation: Reliance Life Sciences Pvt Ltd.

Key inclusion & exclusion criteria

Inclusion criteria: 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.


Exclusion criteria: 1. Patients with any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, Pagetâ??s disease, Cushingâ??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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Post-menopausal women with osteoporosis

Intervention(s)

Intervention1: R-TPR-045: Denosumab 60 mg S.C Injection every 6 months for 12 months
Control Intervention1: Prolia®: Denosumab 60 mg S.C. Injection every 6 months for 12 months

Primary Outcome(s)

Percent change in BMD and T-score at lumbar spine and hipTimepoint: From Baseline to 12 months

Secondary Outcome(s)

To evaluate other efficacy parameters, pharmacokinetics, pharmacodynamics, safety and tolerability of R-TPR-045 / Prolia® (Denosumab)Timepoint: From Baseline to 12 months

Secondary ID(s)

RLS/OST/2016/05 V3 dated 21 Dec 2016

Source(s) of Monetary Support

Reliance Life Sciences Pvt. Ltd

Ethics review

Status: Approved
Approval date: 20/04/2018
Contact:

Ethics Committee, KLE University, Belgaum

Status: Approved
Approval date: 04/05/2018
Contact:

Omega Ethical Committee

Status: Approved
Approval date: 30/06/2018
Contact:

Institutional Ethics Committee, IPGME&R, Kolkata

Status: Approved
Approval date: 02/07/2018
Contact:

Ethics Committee SMS Medical College, Jaipur

Status: Approved
Approval date: 31/07/2018
Contact:

Shree Giriraj Hospital Research Ethics Committee

Status: Approved
Approval date: 04/08/2018
Contact:

Institutional Ethics Committee, Department of Pharmacology, Government Medical College, Nagpur

Status: Approved
Approval date: 04/08/2018
Contact:

Manipal Academy of Higher Education Ethics Committee

Status: Approved
Approval date: 13/08/2018
Contact:

Institutional Ethics Committee, King George Medical University,Lucknow

Status: Approved
Approval date: 17/08/2018
Contact:

Saviour Hospital Ethics Committee

Status: Approved
Approval date: 18/08/2018
Contact:

Sanjivani Hospital Ethics Committee

Status: Approved
Approval date: 17/09/2018
Contact:

Sapthagiri Institute of Medical Sciences and Research Center Institutional Ethics Committee

Status: Approved
Approval date: 29/09/2018
Contact:

Institutional Ethics Committee, Datta Meghe Institute of Medical Sciences, Wardha

Status: Approved
Approval date: 06/10/2018
Contact:

Institutional Ethics Committee KIMS

Status: Approved
Approval date: 11/01/2019
Contact:

Institutional Ethics Committee, Mysore Medical College and Research Institute and Associated Hospitals

Status: Approved
Approval date: 29/03/2019
Contact:

Ethics Committee, GSVM Medical College, Kanpur

Status: Approved
Approval date: 08/04/2019
Contact:

Institutional Ethics Committee, Vijay Vallabh Hospital