Health Condition 1: null- Postmenopausal Osteoporosis
Conditions
Interventions
Intervention1: Denosumab: Each single use prefilled syringe containing 1 ml of solution of reference drug will contain 60 mg of Denosumab (60 mg/ml) as the active ingredient.
Control Intervention1: D
Sponsors
Alkem Laboratories Limited
Enzene Biosciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women with at least 5 years of post-menopause aged > 50 to 80 years; 2. Have low bone mass determined by a bone density test (Dual- energy X-ray Absorptiometry [DXA]), Bone Mineral Density (BMD) T-scores 3. Women giving written, voluntary informed consent for study participation.
Exclusion criteria
Exclusion criteria: 1. Women with vertebral abnormalities at L1 to L4 that may interfere with the vertebral assessment by DXA 2. Vitamin D deficiency as indicated by serum levels of 25-OH vitamin D test, vitamin D 3. Subjects with hyperparathyroidism or hypoparathyroidism at screening 4. Subjects with thyroid dysfunction 5. Subjects with hypocalcemia or hypercalcemia 6. Subjects with Rheumatoid arthritis 7. Any previous treatment with bisphosphonates in the last 12 months prior to screening 8. Previous treatment with any other drug affecting bone metabolism in the last 3 months prior to screening; 9. Subjects with abnormal laboratory findings at screening: ïâ??· Total Bilirubin > 1.5 times the Upper Limit of the Normal (ULN) laboratory range; ïâ??· ALT and/or AST > 2.5 x ULN; ïâ??· Unexplained elevation of ALP; ïâ??· Serum Creatinine > ULN 10. Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) at screening; 11. Subject with any evidence of metabolic bone disease other than osteoporosis, which may interfere with the interpretation of the findings, such as Osteomalacia, Osteogenesis Imperfecta, Pagetââ?¬•s disease, Cushingââ?¬•s disease, Hyperprolactinemia. 12. Subject with any malignancy 13. Subjects with known hypersensitivity to Denosumab or any of its excipients; 14. Any of the following Oral/Dental conditions: ïâ??· Prior history or current evidence of osteomyelitis or osteonecrosis of jaw ïâ??· Active dental or jaw condition which requires oral surgery ïâ??· Planned invasive dental procedure ïâ??· Non-healed dental or oral surgery 15. Malabsorption syndrome or any gastrointestinal disorders that are associated with malabsorption 16. Subjects with clinical evidence of active or chronic infective illness 17. Patients on immunosuppressive therapy 18. Any significant medical illness that is preventing the subject from study participation 19. Subjects who are unwilling or unable to comply with the requirements of the protocol 20. Subject who has participated in any other clinical study in last 30 days. 21. Subject with Hip replacement surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy and safety of Biosimilar Denosumab (Enzene Biosciences Limited) with Innovator Denosumab in subjects with postmenopausal osteoporosisTimepoint: Percent change in Lumbar and Femoral neck Bone Mineral Density (BMD) from baseline to Month 6 and Month 12 of will be evaluated to provide the mean difference of treatments | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the pharmacodynamics (PD) response of study drugs in postmenopausal osteoporosis To assess the pharmacokinetics (PK) profile of Biosimilar Denosumab (Enzene Biosciences Limited) and Innovator Denosumab in subset of subjects (a total of 30 evaluable subjects i.e. 15 subjects in Biosimilar Denosumab arm and 15 subjects in Innovator Denosumab arm) with postmenopausal osteoporosisTimepoint: Month 1, Month 6 and Month 12 of treatment | — |
Countries
India
Contacts
Public ContactMr Vinayaka Shahavi
Alkem Laboratoroes Limited
Outcome results
None listed