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

Postmenopausal Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02478879
• Other study ID #: CP-2015-005
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2015
• Last updated: August 21, 2016
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Zosano Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• Postmenopausal with prior diagnosis of osteoporosis

Exclusion Criteria:

• Significant health issue

• previous use of teriparatide

• History of Paget's disease

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• ZP-PTH
Patch applied daily for 30 minutes, 14 days
• FORTEO
Subcutaneous injection administration daily for 14 days

Locations

Country	Name	City	State
United States	Covance Daytona Beach Clinical Research Unit	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Zosano Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Preference	The fraction of subjects expressing an overall preference for each treatment based on a 4 point scale	28 days	No
Secondary	Safety (adverse events)	incidence of adverse events	28 days	Yes