Postmenopausal Osteoporosis Clinical Trial
Official 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
Verified date | August 2016 |
Source | Zosano Pharma Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 55 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Postmenopausal with prior diagnosis of osteoporosis Exclusion Criteria: - Significant health issue - previous use of teriparatide - History of Paget's disease |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Covance Daytona Beach Clinical Research Unit | Daytona Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Zosano Pharma Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Preference | The fraction of subjects expressing an overall preference for each treatment based on a 4 point scale | 28 days | No |
Secondary | Safety (adverse events) | incidence of adverse events | 28 days | Yes |
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