NCT02478879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 23, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

June 16, 2015

Last Update Submit

August 21, 2016

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Overall Preference

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

    28 days

Secondary Outcomes (1)

  • Safety (adverse events)

    28 days

Study Arms (2)

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

ZP-PTHDRUG

Patch applied daily for 30 minutes, 14 days

Also known as: PTH, parathyroid hormone, teriparatide
ZP-PTH Patch
FORTEODRUG

Subcutaneous injection administration daily for 14 days

Also known as: PTH, FORSTEO, teriparatide
FORTEO(R) Pen

Eligibility Criteria

Age55 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal with prior diagnosis of osteoporosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Daytona Beach Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Parathyroid HormoneTeriparatide

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Hugh Coleman, DO

    Convance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2015

First Posted

June 23, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

August 23, 2016

Record last verified: 2016-08

Locations

US(1)