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Completed

NCT Number: NCT02478879

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

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.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

55 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Covance Daytona Beach Clinical Research Unit

Daytona Beach, Florida, 32117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal with prior diagnosis of osteoporosis

Exclusion criteria

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

Treatment and study plan

ZP-PTH

Drug

Patch applied daily for 30 minutes, 14 days

Other names: PTH, parathyroid hormone, teriparatide

Forteo

Drug

Subcutaneous injection administration daily for 14 days

Other names: PTH, FORSTEO, teriparatide

Primary outcomes

  1. Overall Preference

    Time frame: 28 days

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

Secondary outcomes

  1. Safety (adverse events)

    Time frame: 28 days

    incidence of adverse events

Sponsors and collaborators

Lead sponsor

Zosano Pharma Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 23, 2015
Registry last updated
Aug 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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