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

NCT ID: NCT02478879

Last Updated: 2016-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postmenopausal Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

ZP-PTH

Intervention Type DRUG

Patch applied daily for 30 minutes, 14 days

FORTEO(R) Pen

Marketed FORTEO 20 mcg, administered daily as a subcutaneous injection to the abdomen or thigh for 14 days of treatment.

Group Type ACTIVE_COMPARATOR

FORTEO

Intervention Type DRUG

Subcutaneous injection administration daily for 14 days

Interventions

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ZP-PTH

Patch applied daily for 30 minutes, 14 days

Intervention Type DRUG

FORTEO

Subcutaneous injection administration daily for 14 days

Intervention Type DRUG

Other Intervention Names

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PTH parathyroid hormone teriparatide PTH FORSTEO teriparatide

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal with prior diagnosis of osteoporosis

Exclusion Criteria

* Significant health issue
* previous use of teriparatide
* History of Paget's disease
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zosano Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hugh Coleman, DO

Role: PRINCIPAL_INVESTIGATOR

Convance

Locations

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Covance Daytona Beach Clinical Research Unit

Daytona Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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CP-2015-005

Identifier Type: -

Identifier Source: org_study_id

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