Health Condition 1: Q782- Osteopetrosis
Conditions
Interventions
Intervention1: Lupinâ??s Denosumab: Lupinâ??s Denosumab 60 mg solution for injection (60 mg/mL) in pre-filled syringe administered as subcutaneous injection at day 0 and month 6 of the study.
Control
Sponsors
Lupin Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women with osteoporosis. A woman is considered postmenopausal if she meets any of the following criteria: • Lack of menstrual period for at least 12 months prior to screening, for which there is no other pathological or physiological cause. • Have had surgical bilateral oophorectomy (with or without hysterectomy) at least six months ago. (Serum follicle stimulating hormone [FSH] and serum estradiol level tests can be done at screening in case of uncertainty.) 2. Age >= 55 and 3. Absolute bone mineral density consistent with T-score >= -4.0 at the lumbar spine as measured by Dual-energy X-ray absorptiometry (DXA). 4. At least two vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA. 5. Patients willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Body weight of = 95 kg at screening. 2. Presence of one severe or more than two moderate vertebral fractures as determined by spine X-ray during the screening period. 3. Inadequate renal function at the screening defined as patient on dialysis or estimated glomerular filtration rate (eGFR) 4. Presence of clinically significant leukopenia, neutropenia, or anaemias judged by the investigator. 5. Prior denosumab and strontium or fluoride administration. 6. Ongoing and/or prior administration of the following medicines for osteoporosis: a. Intravenous bisphosphonates: dose received within 5 years prior to screening. b. Oral bisphosphonates used > 3 years cumulative use, and any dose within 12 months of screening. c. Teriparatide or any parathyroid hormones (PTH) analogues: dose received within 6 weeks prior to screening. d. Tibolone, oral, or topical (e.g., transdermal, intravaginal) estrogen, selective estrogen receptor modulators (SERMs): dose received within 6 weeks prior to screening. e. Calcitonin: dose received within 6 weeks prior to screening. f. Active Vitamin D dose received within 2 weeks prior to screening. 7. Systemic glucocorticosteroids (>= 5 mg prednisone equivalent per day for >= 10 days or a total cumulative dose of >= 50 mg) within the past 3 months before screening. 8. Other bone active drugs (i.e., drugs affecting bone metabolism) including heparin, anti-epileptics (except for benzodiazepines and pregabalin), systemic ketoconazole, adrenocorticotrophic hormone (ACTH), lithium, protease inhibitors, gonadotropinreleasing hormone (GnRH) agonists, or anabolic steroids within the past 3 months prior to screening. 9. Receiving or has received any investigational drug (or is currently using an investigational device) within 3 months before receiving IMP, or at least 10 times the respective elimination half-life (whichever period is longer). 10. Abnormal serum calcium (re-test and rescreening is permitted): current hypocalcemia ( 11. Abnormal serum calcium (re-test and rescreening is permitted): current hypocalcemia ( 12. Vitamin D deficiency (25-hydroxy vitamin D levels cut-off at rescreening is permitted). 13. History and/or presence of following bone conditions: bone metastases, renal osteodystrophy, Pagetâ??s disease, osteogenesis imperfect, osteopetrosis, osteomyelitis, Pottâ??s disease (tuberculosis of spine), Cushingâ??s syndrome. 14. Current or prior use of romosozumab or antisclerostin antibody. 15. Current hypoparathyroidism or hyperparathyroidism other than clinically not significant secondary hyperparathyroidism as judged by the investigator. 16. Major surgery within 8 weeks before screening or planned, anticipated major surgery during the study. 17. History and/or presence of malignancy (except completely cured in situ cervical carcinoma or non-metastatic squamous or basal cell carcinoma of the skin). Patient with history of malignancy without recurrence for more than 5 years can be included. 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in Bone Mineral Density (BMD) at the lumbar spine at Month 12. Note: L1-L4 region should be included.Timepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Efficacy Endpoints Percent change from baseline in BMD at the lumbar spine at Month 6 Percent change from baseline in BMD at the total hip & femoral neck at Month 6 & Month 12. 2 Safety Endpoint Number of patients with treatment emergent adverse events (TEAEs) & Serious adverse events (SAEs). 3 Immunogenicity Endpoint Proportion of patients with treatment emergent anti-Denosumab antibodies (binding & neutralizing) at month 3, 6, 9, & 12. 4 Pharmacokinetic Endpoint Descriptive (pharmacokinetic [PK]) assessment of Serum Denosumab concentration.Timepoint: 3, 6, 9 & 12 months | — |
Countries
India, Japan
Contacts
Public ContactDr Neelam Kardekar
Lupin Limited
Outcome results
None listed