Health Condition 1: M810- Age-related osteoporosis without current pathological fracture
Conditions
Interventions
Intervention1: Test Product (T): Teriparatide of Intas Pharmaceutical Limited: Active content: Teriparatide [rhPTH (1-34)]
Dose: 20 microgram once daily
Dosage form: Multi-dose pre-filled delivery device (pen) for injection
Manufacturer: Intas Pharmaceuticals Limited, India
Duration of therapy: 24 weeks and 36 weeks for patients found positive for anti drug-antibodies at week 24
Control Intervention1: Reference Product (R): Forteo: Active content: Teriparatide [rhPTH (1-
Dosage form: Multi-dose pre-filled delivery device (pen) for injection (USFDA)
Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA
Duration of therapy: 24 weeks and 36 weeks for patients found positive for anti drug-antibodies at week 24
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women should be aged 55 to 75 years (both inclusive), ambulatory and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. 2. Postmenopausal women with evidence of osteoporosis DXA derived lumbar spine BMD T score less than or equal to -2.5 standard deviation (SD) as assessed by the central imaging facility at the time of screening. 3. At least 2 vertebrae in the L1 to L4 region and at least one hip joint should be evaluable by DXA as confirmed by the central imaging facility at the time of screening. 4. Women are considered postmenopausal and not of childbearing potential if, a. They have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms); OR b. Six months of spontaneous amenorrhea with serum FSH levels greater than 40 mIU/mL; OR c. Have undergone surgical bilateral oophorectomy (with or without hysterectomy) at least six months ago. If conducted bilateral oophorectomy alone, then only when the reproductive status of the woman has been confirmed by follow up hormone level assessment, she will be considered as not of childbearing potential. 5. Written informed consent must be obtained before any assessment is performed. 6. Should be able to communicate appropriately with the investigator and be able to understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. History of Hypersensitivity to teriparatide or to any of the study drugs or to drugs of similar chemical classes (PTH, PTH derived products like teriparatide, E coli derived products) or any of the excipients (eg, glacial acetic acid, sodium acetate, mannitol, metacresol, hydrochloric acid, sodium hydroxide). 2. Pregnant or nursing (lactating) women. 3. Smokers or use of tobacco in any form (use of tobacco products in the previous 3 months). Smokers will be defined as any participant who reports tobacco use. 4. Fracture and fracture history. a. History and /or presence of 1 severe fracture or 2 moderate vertebral fractures as evaluated by central imaging facility b. History of hip fracture. c. Participants with new bone fracture within 12 weeks before randomization period. d. Participants who have undergone surgery for vertebral body fracture within 12 weeks before the randomization period. 5. Use of the following agents affecting bone metabolism: a. IV bisphosphonates i. Zoledronic acid- Any dose received within 3 years prior to randomization visit ii. IV ibandronate or IV pamidronate: any dose received within 12 months prior to randomization b. Oral bisphosphonates in the last 6 months before randomization c. Strontium ranelate or fluoride (for osteoporosis): More than 1 month of cumulative use within 5 years prior to randomization d. Denosumab or any cathepsin K inhibitor: Any dose received within 12 months prior to randomization e. Teriparatide or any PTH analogs: Any previous use prior to randomization visit f. Systemic, oral or transdermal estrogen, or SERMs (Selective estrogen receptor modulators): More than 1 month of cumulative use within 6 months prior to randomization g. Hormonal ablation therapy: More than 1 month of cumulative use within 6 months prior to randomization h. Tibolone, cinacalcet, or calcitonin: Any dose received within 3 months prior to randomization i. Systemic glucocorticoids: greater than or equal to 5 mg prednisone equivalent per day for more than 14 days within 3 months prior to randomization visit. 6. Laboratory parameters outside ranges as described below. a. Hemoglobin less than 9 g/dL b. Unexplained elevations of alkaline phosphatase greater than 2x upper limit of normal (ULN) c. Alanine transaminase (ALT) and/or aspartate transaminase (AST) greater than 2x ULN d. Total bilirubin greater than 1.5xULN (Isolated bilirubin greater than 1.5xULN is acceptable if total bilirubin is fractionated and direct bilirubin less than 35 percentage) e. Estimated glomerular filtration of less than 45 mL/min using the CKD-EPI equation as assessed by the central laboratory. f. Current hyper or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range. Albumin-adjusted serum calcium levels can be retested once in case of an elevated albumin-adjusted serum calcium level within 1.1x the upper limit of normal (ULN). g. Vitamin D insufficiency, defined as 25 (OH) vitamin D levels less than 20 ng/mL, as determined by the central laboratory. Vitamin D repletion will be permitted and participants may be rescreened once. 7. Current, uncontrolled hyper or hypothyroidism, defined as thyroid-stimulating hormone and thyroxine outside of the normal range (Total T3-1.49 to 2.60 nmol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the immunogenicity of Teriparatide of Intas Pharmaceutical Limited and Forteo in postmenopausal women with osteoporosisTimepoint: Incidence of anti-teriparatide antibodies after 24 weeks of treatment with teriparatide of Intas Pharmaceutical Limited or Forteo. Assessment at 36 weeks for patients found positive for anti drug-antibodies at week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the efficacy of Teriparatide of Intas Pharmaceutical Limited and Forteo. 2. To compare the safety and tolerability of Teriparatide of Intas Pharmaceutical Limited with Forteo. 3. To assess the impact of immunogenicity on pharmacokinetics of Teriparatide of Intas Pharmaceutical Limited and Forteo. Timepoint: 1. Mean percentage change from baseline in BMD at lumbar spine at 24 weeks. 2. Mean percentage change from baseline in BMD at total hip and femoral neck at 24 weeks. 3. Mean percentage change from baseline in serum procollagen I N-terminal propeptide and serum C-terminal telopeptide for type I collagen at week 4, 16 and 24. 4. Fracture incidences through week 24. 5. Teriparatide Cmax and AUC0-4hr for baseline dose (i.e. after administration of first dose) and at week 24. | — |
Countries
India
Contacts
Public ContactPrashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed