NCT01321723

Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women

A Double Blind, Randomized, Repeat Dose Parallel Group Study of Recombinant Human Parathyroid Hormone Analog Tablets, or Placebo Tablets, Compared to Open Label Forsteo® in Postmenopausal Women With Osteoporosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Unigene Laboratories Inc. · Industry
• Sex: Female
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to provide information about the bone anabolic properties and absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of 24 weeks to postmenopausal women with osteoporosis.

Detailed description

The choice of a 24-week treatment period was based on published studies of PTH which demonstrate its potential to produce a statistically significant increase in BMD in patients with postmenopausal osteoporosis within that observation period.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	PTH analog	A recombinant 1-31 amino acid fragment of PTH.
DRUG	Placebo
DRUG	Forsteo (Teriparatide)	A recombinant 1-34 amino acid fragment of PTH.

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-03-23
• Last updated: 2013-03-01
• Results posted: 2013-02-21

Locations

4 sites across 2 countries: Denmark, Estonia