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A Study to Determine the Patient Preference Between Zosano Pharma Parathyroid Hormone (ZP-PTH) Patch and Forteo Pen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02478879
Recruitment Status : Completed
First Posted : June 23, 2015
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):
Zosano Pharma Corporation ( Zosano Pharma Inc. )

Tracking Information
First Submitted Date  ICMJE June 16, 2015
First Posted Date  ICMJE June 23, 2015
Last Update Posted Date August 23, 2016
Study Start Date  ICMJE June 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
Overall Preference [ Time Frame: 28 days ]
The fraction of subjects expressing an overall preference for each treatment based on a 4 point scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
Safety (adverse events) [ Time Frame: 28 days ]
incidence of adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine the Patient Preference Between Zosano Pharma Parathyroid Hormone (ZP-PTH) Patch and Forteo Pen
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postmenopausal Osteoporosis
Intervention  ICMJE
  • Drug: ZP-PTH
    Patch applied daily for 30 minutes, 14 days
    Other Names:
    • PTH
    • parathyroid hormone
    • teriparatide
  • Drug: FORTEO
    Subcutaneous injection administration daily for 14 days
    Other Names:
    • PTH
    • FORSTEO
    • teriparatide
Study Arms  ICMJE
  • Experimental: ZP-PTH Patch
    Intradermal microneedle patch coated with 40 mcg of PTH, applied intracutaneously to the abdomen daily for 30 minutes, 14 days of treatment
    Intervention: Drug: ZP-PTH
  • Active Comparator: FORTEO(R) Pen
    Marketed FORTEO 20 mcg, administered daily as a subcutaneous injection to the abdomen or thigh for 14 days of treatment.
    Intervention: Drug: FORTEO
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 22, 2015)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postmenopausal with prior diagnosis of osteoporosis

Exclusion Criteria:

  • Significant health issue
  • previous use of teriparatide
  • History of Paget's disease
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02478879
Other Study ID Numbers  ICMJE CP-2015-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zosano Pharma Corporation ( Zosano Pharma Inc. )
Study Sponsor  ICMJE Zosano Pharma Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hugh Coleman, DO Convance
PRS Account Zosano Pharma Corporation
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP