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

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Postmenopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: PTH analog
* Drug: Placebo
* Drug: Forsteo (Teriparatide)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy postmenopausal women (45-80 years old) with a diagnosis of osteoporosis Exclusion Criteria: Use of estrogen or hormone replacement therapy Use of bisphosphonates, strontium ranelate or denosumab Use of parathyroid analogues or other bone metabolic agents Medical conditions which might alter bone metabolism Any known clinically significant disease affecting calcium metabolism or history of metabolic disorders including Paget's disease, osteogenesis imperfecta, or osteomalacia Impairment of thyroid function

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTH analog tablet<br>PTH(1-31) 5 mg tablet, once daily | Drug: PTH analog<br>* A recombinant 1-31 amino acid fragment of PTH.<br>* Other names: PTH(1-31);|
| Placebo Comparator: Placebo<br>Placebo matching tablet, once daily | Drug: Placebo<br> <br> |
| Active Comparator: Forsteo<br>Forsteo (teriparatide) 20 mcg SC Injection, once daily | Drug: Forsteo (Teriparatide)<br>* A recombinant 1-34 amino acid fragment of PTH.<br>* Other names: Forteo (US);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24 |  | 24 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24 | Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used. | 24 weeks from baseline | 
| Systemic Absorption of PTH at Week 24 | AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours) | 24 weeks | 
| % Change From Baseline in Bone Formation Marker (P1NP) at Week 24 |  | 24 weeks from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, Bone Diseases, Metabolic, Bone Diseases, Bone Density Conservation Agents