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

Unigene Laboratories Inc.97 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Postmenopausal Osteoporosis

Interventions

PTH analogDRUG

A recombinant 1-31 amino acid fragment of PTH.

PlaceboDRUG

Forsteo (Teriparatide)DRUG

A recombinant 1-34 amino acid fragment of PTH.

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

CCBR

Aalborg, Denmark

CCBR

Ballerup Municipality, Denmark

CCBR

Vejle, Denmark

CCBR

Tallinn, Estonia

Outcomes

Primary Outcomes

% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24

Time frame: 24 weeks from baseline

Secondary Outcomes

% 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.

Time frame: 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)

Time frame: 24 weeks

% Change From Baseline in Bone Formation Marker (P1NP) at Week 24

Time frame: 24 weeks from baseline

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.