A Prospective, Comparative, Randomized Multicenteric Phase III study to compare the Safety and efficacy of Teriparatide [recombinant human parathyroid hormone (1-34)] of Intas Biopharmaceuticals Ltd. against Forteo of Eli-Lilly in postmenopausal females with Osteoporosis

Intas Biopharmaceuticals Limited0 个研究点目标入组 120 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.Post menopausal female patients with an age  45 years and least one year since the last menstruation. If a patient?s menopausal status at screening is in question, by history or due to the patient having a hysterectomy without oophorectomy, a follicle-stimulating hormone (FSH) level to be obtained. Patients with an FSH > 40 mIU/mL will satisfy the definition of postmenopausal status.
•2.Women who are 45-54 years of age with the following bone mineral density (BMD) and/or vertebral fracture:
•BMD 3.0 standard deviations (SDs) or more below peak bone mass of young females at the lumbar spine or
•BMD 2.5 SDs or more below peak bone mass of young females at the lumbar spine with the presence of a vertebral fracture
•3.Women 55 or more years of age with the following BMD and/or vertebral fracture:
•BMD 2.5 SDs or more below peak bone mass of young females at the lumbar spine, or
•BMD 2.0 SDs or more below peak bone mass of young females at the lumbar spine with the presence of a vertebral fracture
•4.Women who are capable of understanding and giving written, voluntary informed consent before the clinical trial screening visit
•5.Patient must be recombinant Human Parathyroid Hormone naive

•1.Male patients
•2.Female < 45 years
•3.Patients diagnosed with Paget?s disease
•4.Prior external beam or implant radiation therapy involving the skeleton
•5.Patients with bone metastasis
•6.Metabolic bone disease other than Osteoporosis
•7.Pre existing hypercalcemia: Serum calcium greater than 10.2 mg/dL (2.55 mmol/L)
•8.Hypersensitivity to the product or its constituents
•9.Any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results
•10.Patient who are receiving or will receive and have received in past 30 days any of the following therapy:
•?Calcitonin
•?Bisphosphonates
•?Anabolic Androgens and steroids
•?Estrogen replacement therapy.
•?Methotrexate
•?Selective estrogen receptor modulators
•11.Have received any Investigational product in last 30 days or going to receive any Investigational product during the study period.
•12.Patient with confirmatory diagnosis of carcinoma
•13.Suspected or confirmed poor compliance, according to investigators judgment, in completing the trial and follow up.

发起方

Intas Biopharmaceuticals Limited