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

Phase 2

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: PTH analog; Drug: Placebo; Drug: Forsteo (Teriparatide)

• Registration Number: NCT01321723
• Lead Sponsor: Unigene Laboratories Inc.

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-16
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2012-12-12
• Status Verified: 2013-01
• Results First Submitted QC: 2013-01-17
• Results First Posted: 2013-02-21
• Last Update Submitted: 2013-02-21
• Last Update Posted: 2013-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTH analog tablet	PTH analog	PTH(1-31) 5 mg tablet, once daily
Placebo	Placebo	Placebo matching tablet, once daily
Forsteo	Forsteo (Teriparatide)	Forsteo (teriparatide) 20 mcg SC Injection, once daily

Primary Outcome Measures

Name	Time	Method
% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24	24 weeks from baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CCBR; 🇪🇪 Tallinn, Estonia