Health Condition 1: M810- Age-related osteoporosis without current pathological fracture
Conditions
Interventions
Intervention1: Biosimilar Teriparatide: 20 microgram once daily via subcutaneous self-injection for 52 weeks.
Control Intervention1: Forteo : 20 microgram once daily via subcutaneous self-injection fo
Sponsors
Levim Lifetech Pvt. Ltd
Levim Lifetech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Ambulatory male and postmenopausal female subject of age more than equal to 45 to less than equal to 80 years at the time of screening. 2.Post menopausal female subjects as per following definition 2.1 Amenorrhea for at least 12 consecutive months prior to screening. OR 2.2 Subject with 6 months of spontaneous amenorrhea with serum FSH levels more than 40 mIU^mL. OR 2.3 Surgical menopause (bilateral oophorectomy with or without hysterectomy) more than equal to 06 Weeks before screening. 3.Bone Mineral Density The subject having a BMD absolute value consistent with a T-score of more than equal to -2.5 at either the lumbar spine (L2-L4) or femoral neck or total hip. 4.Body mass index (BMI) more than equal to 18.5 kg^m2 and less than equal to 30 kg^m2. BMI values should be rounded to the nearest integer (e.g. 29.4 rounds down to 29, while 19.5 rounds up to 19). 5.Males must be willing to use adequate methods of contraception throughout the study. 6.The subject is capable of correct use of injectable devices and taking assigned Investigational Product (IP) as directed. 7.In good general health as determined by medical history, physical examination, vital sign, and laboratory tests and able to walk without assistance. 8.Subjects 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, except for osteoporosis, including osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings, Pagets disease, Cushings disease or Hyperprolactinemia, fibrous dysplasia, rheumatoid arthritis, ankylosing spondylitis or an unexplained elevation of alkaline phosphatase (greater than 2 ULN). 2.Current hyperparathyroidism or hypoparathyroidism 3.History of uncontrolled Hyper or hypothyroidism except subjects on stable thyroid hormone replacement therapy. 4.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. Any history of bone metastases, implant radiation involving the skeleton, or skeletal malignancies is to be excluded. 5.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 Gilberts syndrome or asymptomatic gallstones). 6.Stage 2 or 3 or 4 congestive heart failure as per New York Heart Association (NYHA) guidelines, recent myocardial infarction (within 6 months prior to Visit 1) or any unstable cardiovascular disease, pulmonary disease, or autoimmune disease requiring chronic anti-inflammatory therapy or disease-modifying agents. 7.Subject with inadequately treated hypertension (systolic more than equal to 140 mm Hg or diastolic more than equal to 90 mm Hg). 8.Subject with Type I diabetes mellitus. 9.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. 10.Any physical or psychiatric disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures. 11.Known to have tested positive for human immunodeficiency virus (HIV), HCV and HBsAg. 12.Subjects with Vitamin D deficiency: (25(OH) vitamin D level less than 20 ng^mL). Vitamin D repletion will be done and subjects may be re-screened with 25(OH) vitamin D after 3 months. 13.Any of the following Oral/Dental Conditions: 13.1 Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw. 13.2 Active dental or jaw condition which requires oral surgery. 13.3 Planned invasive dental procedure. 13.4 Non-healed dental or oral surgery. 14.Administration of intravenous (IV) bisphosphonates, fluoride or strontium within the last 1 year. 15.Subjects who have undergone Oral bisphosphonates treatment in past shall be 15.1 Ineligible if Oral bisphosphonates have been used for 3 years or more cumulatively. 15.2 If used for less than 3 years, a gap of at least 6 months since last dose administered is required. 16.Administration of any of the following treatments: 16.1 Any current or prior use of Denosumab, cathepsin K inhibitors (odanacatib) or any Parathyroid hormone (PTH) or PTH derivatives, e.g., teriparatide. 16.2 Anabolic steroids or testosterone within last 12 weeks. 16.3 Glucocorticosteroids (more than 5 mg prednisone equivalent per day for more than 10 days) within last 12 weeks. Note The use of topical, ophthalmic, inhalational and intraar
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Percent change in BMD at the lumbar spineTimepoint: Baseline to Day 364 (Week 52) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in BMD at the lumbar spine , total hip and femoral neckTimepoint: Baseline to Day 364 (Week 52);Incidence of FractureTimepoint: Baseline to Day 364 (Week 52);Incidence of non-vertebral fracturesTimepoint: Baseline to Day 364 (Week 52);Compare the pharmacokinetic parametersTimepoint: Pre-dose, Post dose at 0.083-6.0 Hours;Change in bone turnover markers procollagen type 1 N propeptide (P1NP), c-terminal cross-linked telopeptide of type 1 collagen (CTX-1) and bone-specific alkaline phosphatase (BSAP) levelsTimepoint: Baseline, Day 168 and Day 364;Incidence and Titres of anti-drug antibody (ADA)Timepoint: Baseline, Day 364;Incidence of TEAEs and SAEsTimepoint: Throughout the study period | — |
Countries
India
Contacts
Public ContactMr Kartik Sahni
Insignia Clinical Services Pvt. Ltd.
Outcome results
None listed