CTRI/2018/05/013924Active, not recruitingPhase 3
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
Reliance Life Sciences Pvt Ltd16 sites in 1 country159 target enrollmentStarted: June 20, 2018Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 159
- Locations
- 16
- Primary Endpoint
- Percent change in BMD and T-score at lumbar spine and hip
Study Overview
Brief Summary
This will be aprospective, multi-centre, double-blind, two-arm, parallel group, activecontrol, 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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- Female
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, 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.
Outcomes
Primary Outcomes
Percent change in BMD and T-score at lumbar spine and hip
Time Frame: From Baseline to 12 months
Secondary Outcomes
- To evaluate other efficacy parameters, pharmacokinetics, pharmacodynamics, safety and tolerability of R-TPR-045 / Prolia® (Denosumab)(From Baseline to 12 months)
Investigators
Study Sites (16)
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