A study of Denosumab in postmenopausal women and men with osteoporosis (weak and brittle bones) at high risk of fracture
- Conditions
- Health Condition 1: M808- Other osteoporosis with current pathological fracture
- Registration Number
- CTRI/2018/10/016049
- Lead Sponsor
- Intas Pharmaceuticals Ltd Biopharma Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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,
11. Any physical or psychiatric disorder that compromises the ability of the patient to give written informed consent or to comply with study procedures.
12. Tested positive for HIV, HCV or HBsAg during screening.
13. 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.
e. Poor oral hygiene
f. Co-morbid disorders (e.g. periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures)
14. Administration of intravenous (IV) bisphosphonates, fluoride, or strontium for osteoporosis within the last 1 year.
15. Oral bisphosphonates treatment for osteoporosis in last 3 months.
16. Currently receiving chemotherapy, corticosteroids and/or angiogenesis inhibitors
17. Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or patient is receiving other investigational agent(s).
18. Any of the following abnormal investigational values
a. General: Any laboratory abnormality which, in the opinion of the Investigator, would prevent the patient from completing the study or interfere with the interpretation of the study results.
b. Abnormal serum calcium: current hypercalcaemia or hypocalcaemia.
c. Liver transaminases:
i. Serum aspartate aminotransferase (AST; serum glutamate-oxaloacetic transaminase [SGOT]) >=2.0x upper limits of normal [ULN]).
ii. Serum alanine aminotransferase (ALT; serum glutamate-pyruvate transaminase [SGPT]) 2.0 x ULN).
19. DXA measurements:
a. Less than 2 lumbar vertebrae evaluable for DXA measurements. Height, weight, or girth which may preclude accurate DXA measurements.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the long-term safety of Intas DenosumabTimepoint: At the end of 5 years
- Secondary Outcome Measures
Name Time Method Evaluation of the long-term efficacy of Intas DenosumabTimepoint: At the end of 1, 2, 3, 4 and 5 years