Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. )

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.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: ZP-PTH Drug: FORTEO Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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
  • FORSTEO
  • teriparatide




Primary Outcome Measures :
  1. Overall Preference [ Time Frame: 28 days ]
    The fraction of subjects expressing an overall preference for each treatment based on a 4 point scale


Secondary Outcome Measures :
  1. Safety (adverse events) [ Time Frame: 28 days ]
    incidence of adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal with prior diagnosis of osteoporosis

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02478879


Locations
Layout table for location information
United States, Florida
Covance Daytona Beach Clinical Research Unit
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Zosano Pharma Inc.
Investigators
Layout table for investigator information
Principal Investigator: Hugh Coleman, DO Convance
Layout table for additonal information
Responsible Party: Zosano Pharma Inc.
ClinicalTrials.gov Identifier: NCT02478879    
Other Study ID Numbers: CP-2015-005
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Teriparatide
Parathyroid Hormone
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents