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

Information source: Zosano Pharma Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postmenopausal Osteoporosis

Intervention: ZP-PTH (Drug); FORTEO (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Zosano Pharma Inc.

Official(s) and/or principal investigator(s):
Hugh Coleman, DO, Principal Investigator, Affiliation: Convance

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.

Clinical Details

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

Primary outcome: Overall Preference

Secondary outcome: Safety (adverse events)

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.

Eligibility

Minimum age: 55 Years. Maximum age: 85 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Postmenopausal with prior diagnosis of osteoporosis

Exclusion Criteria:

- Significant health issue

- previous use of teriparatide

- History of Paget's disease

Locations and Contacts

Covance Daytona Beach Clinical Research Unit, Daytona Beach, Florida 32117, United States
Additional Information

Starting date: June 2015
Last updated: July 14, 2015

Page last updated: August 20, 2015

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