CTRI/2021/04/032769已完成3 期
A randomized, assessor-blind, multicenter, parallel arm study comparing immunogenicity potential of Teriparatide of Intas Pharmaceutical Limited with Forteo in postmenopausal women with osteoporosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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
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