A clinical trial to study the Effects of Denosumab drug in the Treatment of Postmenopausal Osteoporosis
- Conditions
- Health Condition 1: null- Postmenopausal Osteoporosis
- Registration Number
- CTRI/2018/07/014908
- Lead Sponsor
- Alkem Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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 < -2.5 standard deviation (SD) at any one of the two sites measured (lumbar spine [L1 ââ?¬â?? L4] and femoral neck);
3. Women giving written, voluntary informed consent for study participation.
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 < 20 ng/mL at screening
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To assess the pharmacodynamics (PD) response of study drugs in postmenopausal osteoporosis <br/ ><br>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