Back to resultsA Study to Determine the Patient Preference Between Zosano Pharma Parathyroid Hormone (ZP-PTH) Patch and Forteo Pen
Primary Purpose
Postmenopausal Osteoporosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ZP-PTH
FORTEO
Sponsored by
About this trial
This is an interventional treatment trial for Postmenopausal Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Postmenopausal with prior diagnosis of osteoporosis
Exclusion Criteria:
- Significant health issue
- previous use of teriparatide
- History of Paget's disease
Sites / Locations
- Covance Daytona Beach Clinical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ZP-PTH Patch
FORTEO(R) Pen
Arm Description
Intradermal microneedle patch coated with 40 mcg of PTH, applied intracutaneously to the abdomen daily for 30 minutes, 14 days of treatment
Marketed FORTEO 20 mcg, administered daily as a subcutaneous injection to the abdomen or thigh for 14 days of treatment.
Outcomes
Primary Outcome Measures
Overall Preference
The fraction of subjects expressing an overall preference for each treatment based on a 4 point scale
Secondary Outcome Measures
Safety (adverse events)
incidence of adverse events
Full Information
NCT ID
NCT02478879
First Posted
June 16, 2015
Last Updated
August 21, 2016
Sponsor
Zosano Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02478879
Brief Title
A Study to Determine the Patient Preference Between Zosano Pharma Parathyroid Hormone (ZP-PTH) Patch and Forteo Pen
Official Title
An Open-label Crossover Study to Determine the Patient Preference Between ZP-PTH Patches and Forteo Pens After Daily Treatment for 14 Days in Women 55-85 Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zosano Pharma Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ZP-PTH Patch
Arm Type
Experimental
Arm Description
Intradermal microneedle patch coated with 40 mcg of PTH, applied intracutaneously to the abdomen daily for 30 minutes, 14 days of treatment
Arm Title
FORTEO(R) Pen
Arm Type
Active Comparator
Arm Description
Marketed FORTEO 20 mcg, administered daily as a subcutaneous injection to the abdomen or thigh for 14 days of treatment.
Intervention Type
Drug
Intervention Name(s)
ZP-PTH
Other Intervention Name(s)
PTH, parathyroid hormone, teriparatide
Intervention Description
Patch applied daily for 30 minutes, 14 days
Intervention Type
Drug
Intervention Name(s)
FORTEO
Other Intervention Name(s)
PTH, FORSTEO, teriparatide
Intervention Description
Subcutaneous injection administration daily for 14 days
Primary Outcome Measure Information:
Title
Overall Preference
Description
The fraction of subjects expressing an overall preference for each treatment based on a 4 point scale
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Safety (adverse events)
Description
incidence of adverse events
Time Frame
28 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Postmenopausal with prior diagnosis of osteoporosis
Exclusion Criteria:
Significant health issue
previous use of teriparatide
History of Paget's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh Coleman, DO
Organizational Affiliation
Convance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Covance Daytona Beach Clinical Research Unit
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Determine the Patient Preference Between Zosano Pharma Parathyroid Hormone (ZP-PTH) Patch and Forteo Pen
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