CTRI/2018/10/016049
Not yet recruiting
Phase 4
A prospective follow-up study to evaluate the long-term safety of Intas Denosumab in postmenopausal women and men with osteoporosis at high risk of fracture - NA
Intas Pharmaceuticals Ltd Biopharma Division0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: M808- Other osteoporosis with current pathological fracture
- Sponsor
- Intas Pharmaceuticals Ltd Biopharma Division
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Ambulatory woman and men between 18 and 80 years
- •2\. Postmenopausal women with osteoporosis at high risk for fracture or those patients who have failed or are intolerant to other available osteoporosis therapy.
- •a. Postmenopausal female patients with at least one year since the last menstruation. A follicle\-stimulating hormone (FSH) level shall be obtained at the discretion of investigator to confirm the postmenopausal status. Patients with an FSH less than 40 mIU/mL would satisfy the definition of postmenopausal status
- •3\. Men at high risk for fracture or those patients who have failed or are intolerant to other available osteoporosis therapy
- •4\. Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study and ready to comply with the protocol requirements
- •Note: High risk of fracture will be assessed using FRAX criteria for Indian population. All the patients meeting high risk criteria, i.e. 10 year probability of hip or major osteoporotic fractures less than 20%, based on FRAX will be included in the study
Exclusion Criteria
- •1\. History of frequent occurrence of hypocalcaemia or presence of diseases that can precipitate hypocalcaemia frequently (Bowel absorption disorders like malabsorption syndromes and history of excision of small intestine, Severe renal impairment)
- •2\. History of hypersensitivity to mammalian (Chinese hamster ovary) cells derived drugs or any component of the products (Acetic acid, Sodium hydroxide, Sorbitol, Polysorbate 20\)
- •3\. History of latex allergy).
- •4\. 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
- •5\. Current uncontrolled hyperparathyroidism or hypoparathyroidism
- •6\. Denosumab use in the past.
- •7\. History of uncontrolled hyper\- or hypothyroidism; Patients stable therapy for last one year can be included
- •8\. 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.
- •9\. 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).
- •10\. History of alcohol or substance\-abuse within the last 12 months,
Outcomes
Primary Outcomes
Not specified
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