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

Zosano Pharma

Status and phase: Completed; Phase 1

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: ZP-PTH; Drug: FORTEO

Study type: Interventional

Funder types: Industry

Identifiers

NCT02478879

CP-2015-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal with prior diagnosis of osteoporosis

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

ZP-PTH Patch

Experimental group

Description:

Intradermal microneedle patch coated with 40 mcg of PTH, applied intracutaneously to the abdomen daily for 30 minutes, 14 days of treatment

Treatment:

Drug: ZP-PTH

FORTEO(R) Pen

Active Comparator group

Description:

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

Treatment:

Drug: FORTEO