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 Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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.

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