A Study to Determine the Patient Preference Between Zosan... | NCT02478879

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

NCT02478879

Sponsor

Zosano Pharma Corporation

Status

Completed

Last Update Posted

Aug 23, 2016Estimated

Enrollment

24Estimated

Phase

Phase 1

Conditions

Postmenopausal Osteoporosis

Interventions

ZP-PTH
FORTEO

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Nov 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jun 16, 2015

First Submission Date that Met QC Criteria

Jun 22, 2015

First Posted Date

Jun 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2016

Last Update Posted Date

Aug 23, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ZP-PTH Patch	Experimental	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
FORTEO(R) Pen	Active Comparator	Marketed FORTEO 20 mcg, administered daily as a subcutaneous injection to the abdomen or thigh for 14 days of treatment.	Drug: FORTEO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ZP-PTH	Drug	Patch applied daily for 30 minutes, 14 days	ZP-PTH Patch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Preference	The fraction of subjects expressing an overall preference for each treatment based on a 4 point scale	28 days

Secondary Outcomes

Measure	Description	Time Frame
Safety (adverse events)	incidence of adverse events	28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal with prior diagnosis of osteoporosis

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hugh Coleman, DO	Convance	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Covance Daytona Beach Clinical Research Unit		Daytona Beach	Florida	32117	United States

Condition Browse Module

MeSH Terms

ID	Term
D015663	Osteoporosis, Postmenopausal

Ancestor Terms

ID	Term
D010024	Osteoporosis
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010281	Parathyroid Hormone
D019379	Teriparatide

Ancestor Terms

ID	Term
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided