Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02478879
Other study ID # CP-2015-005
Secondary ID
Status Completed
Phase Phase 1
First received June 16, 2015
Last updated August 21, 2016
Start date June 2015
Est. completion date December 2015

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
ZP-PTH
Patch applied daily for 30 minutes, 14 days
FORTEO
Subcutaneous injection administration daily for 14 days

Locations

Country Name City State
United States Covance Daytona Beach Clinical Research Unit Daytona Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Zosano Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05902078 - Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis Phase 4
Completed NCT05087030 - Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis Phase 3
Completed NCT01544894 - Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis Phase 4
Completed NCT00381251 - Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation. Phase 1
Completed NCT00377819 - Study of Transitioning From Alendronate to Denosumab Phase 3
Completed NCT00239629 - Teriparatide and Strontium Ranelate Head-To-Head Comparison Trial Phase 4
Completed NCT04026256 - Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration Phase 4
Terminated NCT00529373 - A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018) Phase 3
Completed NCT00092014 - A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211) Phase 3
Recruiting NCT06079476 - A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture. Phase 4
Not yet recruiting NCT04719650 - Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid Phase 4
Recruiting NCT02981732 - CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome N/A
Completed NCT01709110 - VERtebral Fracture Treatment Comparisons in Osteoporotic Women Phase 4
Completed NCT01348243 - Efficacy Of Clodronate 200 Mg/4 Ml I.M. Solution With 1% Lidocaine Every Other Week Vs Clodronate 100 Mg/3,3ml I.M. Solution With 1% Lidocaine Once-Week In A 1-Year Treatment Period Of Women With Postmenopausal Osteoporosis Phase 3
Completed NCT00541658 - A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis Phase 3
Completed NCT00395395 - Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women Phase 1
Completed NCT00247273 - A Study of Monthly Risedronate for Osteoporosis Phase 3
Active, not recruiting NCT03720886 - G56W1 in Women With Postmenopausal Osteoporosis Phase 1/Phase 2
Completed NCT01668589 - Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis N/A
Completed NCT04664959 - A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis Phase 3