A Study to Determine the Patient Preference Between Zosano Pharma Parathyroid Hormone (ZP-PTH) Patch and Forteo Pen
- Registration Number
- NCT02478879
- Lead Sponsor
- Zosano Pharma Corporation
- Brief Summary
The purpose of this study is to determine which of two delivery methods of Parathyroid Hormone (PTH) is preferred by patients after 14 days of use for each.
- Detailed Description
The purpose of this study is to determine which of two delivery methods of PTH is preferred by patients after 14 days of use for each. Patient preference will be determined by means of patient questionnaires at the end of each treatment period and a final questionnaire after both treatment periods are complete. Adverse events will also be collected.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
Inclusion Criteria
- Postmenopausal with prior diagnosis of osteoporosis
Exclusion Criteria
- Significant health issue
- previous use of teriparatide
- History of Paget's disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ZP-PTH Patch ZP-PTH Intradermal microneedle patch coated with 40 mcg of PTH, applied intracutaneously to the abdomen daily for 30 minutes, 14 days of treatment FORTEO(R) Pen FORTEO Marketed FORTEO 20 mcg, administered daily as a subcutaneous injection to the abdomen or thigh for 14 days of treatment.
- Primary Outcome Measures
Name Time Method Overall Preference 28 days The fraction of subjects expressing an overall preference for each treatment based on a 4 point scale
- Secondary Outcome Measures
Name Time Method Safety (adverse events) 28 days incidence of adverse events
Trial Locations
- Locations (1)
Covance Daytona Beach Clinical Research Unit
🇺🇸Daytona Beach, Florida, United States