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

August 21, 2016 updated by: Zosano Pharma Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Covance Daytona Beach Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal with prior diagnosis of osteoporosis

Exclusion Criteria:

  • Significant health issue
  • previous use of teriparatide
  • History of Paget's disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: ZP-PTH
Patch applied daily for 30 minutes, 14 days
Other Names:
  • PTH
  • parathyroid hormone
  • teriparatide
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.
Drug: FORTEO
Subcutaneous injection administration daily for 14 days
Other Names:
  • PTH
  • teriparatide
  • FORSTEO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Preference
Time Frame: 28 days
The fraction of subjects expressing an overall preference for each treatment based on a 4 point scale
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (adverse events)
Time Frame: 28 days
incidence of adverse events
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zosano Pharma Corporation

Investigators

  • Principal Investigator: Hugh Coleman, DO, Convance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 16, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 23, 2015

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 21, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-2015-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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