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

Zosano Pharma Corporation24 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Postmenopausal Osteoporosis

Interventions

ZP-PTHDRUG

Patch applied daily for 30 minutes, 14 days

FORTEODRUG

Subcutaneous injection administration daily for 14 days

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Postmenopausal with prior diagnosis of osteoporosis Exclusion Criteria: * Significant health issue * previous use of teriparatide * History of Paget's disease

Locations (1)

Covance Daytona Beach Clinical Research Unit

Daytona Beach, Florida, United States

Outcomes

Primary Outcomes

Overall Preference

The fraction of subjects expressing an overall preference for each treatment based on a 4 point scale

Time frame: 28 days

Secondary Outcomes

Safety (adverse events)

incidence of adverse events

Time frame: 28 days

Data from ClinicalTrials.gov

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