CompletedPhase 2ACTRN12615000195550

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

Sponsor

Corium International, Inc

Enrollment

39 participants

Start Date

Feb 16, 2015

Study Type

Interventional

Conditions

Osteoporosis

Summary

Phase 2a open label, randomised study to evaluate the pharmacokinetics and safety of MicroCor hPTH(1-34) Administered via Transdermal Delivery and Subcutaneous Injection [Forteo Registered Trademark (teriparatide)] in healthy postmenopausal volunteers

Eligibility

Sex: FemalesMin Age: 50 YearssMax Age: 85 Yearss

Inclusion Criteria9

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.
-hydroxyvitamin D must be >20 ng/ml at the screening visit.

Exclusion Criteria10

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Part A Treatment A: MicroCor Registered Trademark hPTH(1-34) Transdermal System (TDS) 16 mcg single day application, consecutive day cross over Treatment B: MicroCor Registered Trademark hPTH(1-34)

Part A Treatment A: MicroCor Registered Trademark hPTH(1-34) Transdermal System (TDS) 16 mcg single day application, consecutive day cross over Treatment B: MicroCor Registered Trademark hPTH(1-34) TDS 38 mcg single day application, consecutive day cross over Treatment C: Forteo Registered Trademark teriparatide (rDNA origin) 20 mcg; single subcutaneous injection Treatment E: MicroCor Registered Trademark hPTH(1-34) Transdermal System model 2 (TDS) 38 mcg single day application, consecutive day cross over. Proprietary internal mechanical design differs between TDS and TDS Model 2. Part B Treatment B: MicroCor Registered Trademark hPTH(1-34) Transdermal System (TDS) 38 mcg daily application for 28 days Treatment C: Forteo Registered Trademark teriparatide (rDNA origin) 20 mcg subcutaneous injection daily for 28 days. Treatment B subjects will have Treatment D MicroCor Registered Trademark placebo Transdermal System (TDS) applied concurrently twice over the 28 days. Part A participants will not be recruited into Part B. Subjects will complete a daily dosing diary that will be reviewed by the study staff to monitor adherence.