Study in postmenopausal women with osteoporosis
- Conditions
- Health Condition 1: null- Post-menopausal women with osteoporosis
- Registration Number
- CTRI/2018/05/013924
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change in BMD and T-score at lumbar spine and hipTimepoint: From Baseline to 12 months
- Secondary Outcome Measures
Name Time Method To evaluate other efficacy parameters, pharmacokinetics, pharmacodynamics, safety and tolerability of R-TPR-045 / Prolia® (Denosumab)Timepoint: From Baseline to 12 months