Health Condition 1: M810- Age-related osteoporosis without current pathological fracture
Conditions
Interventions
Intervention1: Denosumab: Dose: 60 mg/ml, Frequency: Once every 6 months, Mode of Administration: Subcutaneously, Duration of treatment: 12 months
Control Intervention1: Prolia: Dose: 60 mg/ml, Frequ
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory woman 2. Bone Mineral Density: The subject having a BMD absolute value consistent with a T-score between -2.5 to -4 at either the lumbar spine or total hip. 3. Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
Exclusion criteria
Exclusion criteria: 1. History of any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings, Pagetâ??s disease, Cushingâ??s disease or Hyperprolactinemia 2. Current hyperparathyroidism or hypoparathyroidism 3. History of uncontrolled Hyper- or hypothyroidism except subjects on stable thyroid hormone replacement therapy for last one year 4. History of Rheumatoid arthritis 5. History of malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5-years. 6. History of Cirrhosis of the liver or Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbertâ??s syndrome or asymptomatic gallstones). 7. History of Drug or alcohol abuse: Evidence of alcohol or substance-abuse within the last 12-months which the Investigator believes would interfere with understanding or completing the study. 8. Any physical or psychiatric disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures. 9. Known to have tested positive for human immunodeficiency virus (HIV), HCV or HBsAg. 10. Any of the following Oral/Dental Conditions a. Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw. b. Active dental or jaw condition which requires oral surgery. c. Planned invasive dental procedure. d. Non-healed dental or oral surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of efficacy of denosumab of Intas Pharmaceuticals Ltd. in comparison with Prolia in women with postmenopausal steoporosis.Timepoint: Visit 1 to Visit 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Pharmacokinetic profile of Investigational Medicinal ProductTimepoint: Visit 1 to Visit 15 | — |
Countries
India
Contacts
Public ContactDevesh Verma
Lambda Therapeutic Research Ltd
Outcome results
None listed