CTRI/2021/04/032769
Completed
Phase 3
A randomized, assessor-blind, multicenter, parallel arm study comparing immunogenicity potential of Teriparatide of Intas Pharmaceutical Limited with Forteo in postmenopausal women with osteoporosis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Intas Pharmaceuticals Ltd
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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