A Phase 2a Open Label Study to Evaluate the Pharmacokinetics and Safety of Parathyroid Hormone hPTH(1-34) Administered via Transdermal Delivery and Subcutaneous Injection [Forteo Registered Trademark (teriparatide)] in Healthy Postmenopausal Women

Corium International, Inc0 个研究点目标入组 39 人开始时间: 2015年3月2日最近更新: 2020年1月13日

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•Post-menopausal woman, aged 50-85 years old at screening in otherwise good general health as determined by the Investigator.
•Agrees to being evaluated for baseline T scores or providing DXA results that are less than 1 year old or subject is
•willing to undergo a DXA scan at the time of screening.
•Must have no clinically significant findings as determined by the Investigator based on physical examination, 12-lead ECG and vital signs
•Clinical laboratory values at screening, including ionized and total calcium, phosphorus, creatinine, albumin, and
•PTH, must be within the normal limits as defined by the clinical laboratory, or are not clinically significant.
•Corrected calcium (total calcium normalized) or albumin concentrations must be < upper limit of normal in ref range
•at the screening visit.
•25-hydroxyvitamin D must be >20 ng/ml at the screening visit.

•Has a diagnosis of osteoporosis, defined by bone mineral densitometry T score at any location on the body.
•Had a loss of height greater than 5cm (2 inches) supported by medical records or subject self report.
•Had recent bone fractures or fragility fractures.
•Has an uncontrolled medical condition in the opinion of the Investigator or a controlled medical condition requiring
•regular treatment with prescription drugs that would influence calcium, bone metabolism or relevant biomarkers.
•Has history of significant chronic disease, cancer or any medical condition known to affect bone metabolism, hepatic or renal disorder requiring medical intervention.
•Prior use of PTH replacement therapy or any of its analogs within the previous year.
•Current use and/or use within the last year of corticosteroids (eye drops and topical creams are acceptable).
•Currently use agents that influence calcium, bone metabolism or relevant biomarkers, such as calcitonins, bisphosphonates, Selective Estrogen Receptor Modulators (SERMs), teriparatide, phenobarbital, phenytoin,
•glucocorticoids or anabolic steroid agents. Exceptions are: prior bisphosphate therapy if commenced one year prior to randomization, stable doses of Vitamin D and calcium supplements for at least three months prior to screening and PRN (as needed) use of anti-nausea medication.

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