Health Condition 1: M810- Age-related osteoporosis without current pathological fracture
Conditions
Interventions
Intervention1: BP16 (Denosumab) single-dose pre-filled syringe for subcutaneous injection.
Dosage Form & Strength: Pre-Filled Syringe for Subcutaneous Injection containing Denosumab 60mg/1ml.
: Dose o
Sponsors
CuraTeQ Biologics Private Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Ambulatory female patients of age 50 to 80 years (both inclusive). 2.Post menopausal female patients with at least one year since the last menstruation. 3.Bone Mineral Density: The subject having a BMD absolute value consistent with a T-score between -2.5 to -4.0 at either the lumbar spine or total hip. 4.Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
Exclusion criteria
Exclusion criteria: 1.History of any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings, Paget’s disease, Cushing’s disease or Hyperprolactinemia. 2.Current hyperparathyroidism or hypoparathyroidism 3.History of uncontrolled Hyper- or hypothyroidism except subjects on stable thyroid hormone replacement therapy. 4.History of Rheumatoid arthritis 5.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. 6.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 Gilbert’s syndrome or asymptomatic gallstones). 7.History of Drug or alcohol abuse: Evidence of alcohol or substance-abuse within the last 12-months which the Investigator believes would interfere with understanding or completing the study. 8.Any physical or psychiatric disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures. 9.Known to have tested positive for human immunodeficiency virus (HIV), HCV, HBsAg. 10.Patients with Vitamin D deficiency: (25-(OH) vitamin D level 11.Any of the following Oral/Dental Conditions i.Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw. ii.Active dental or jaw condition which requires oral surgery. iii.Planned invasive dental procedure. iv.Non-healed dental or oral surgery. 12.Administration of intravenous (IV) bisphosphonates anytime in the past, fluoride or strontium for osteoporosis within the last 3-years. 13.Patients who have undergone Oral bisphosphonates treatment in past shall be: i.ineligible if Oral bisphosphonates have been used for 3 years or more cumulatively. ii.if used for less than 3 years, a gap of at least one year since last dose administered is required. 14.Administration of any of the following treatments within the last 6-weeks: i.Parathyroid hormone (PTH) or PTH derivatives, e.g., teriparatide. ii.Anabolic steroids or testosterone. iii.Gluco-corticosteroids (5 mg prednisone equivalent per day for more than 10 days). iv.Selective estrogen receptor modulators (SERMs), e.g., raloxifene v.Tibolone vi.Calcitonin vii.Other bone active drugs including anti-convulsant (except benzodiazepines) and heparin. viii.Chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists. 15.Currently enrolled in or has not yet completed at least 30-days since ending other investigational device or drug trial(s), or subject is receiving other investiga
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess percent change in BMD at the lumbar spineTimepoint: Baseline to Day 168 | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare Pharmacokinetic & Pharmacodynamic parametersTimepoint: As per pre-specified timepoints in the protocol;Incidence and Titres of Anti-Denosumab Antibodies between both groups.Timepoint: Baseline, Day 84, Day 168;Incidence of FractureTimepoint: Baseline to Day 168;Percent change in BMD at the femoral neck fromTimepoint: Baseline to Day 168;Percent change in BMD at the total hip fromTimepoint: Baseline to Day 168;Treatment Emergent Adverse Events (TEAEs) evaluated on the basis of changes in clinical signs & symptoms and changes in safety laboratory values.Timepoint: Baseline to Week 24 | — |
Countries
India
Contacts
Public ContactKartik Sahni
CuraTeQ Biologics Private Ltd.
Outcome results
None listed