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

NCT01321723 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2013-03-01

Study results available
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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.

Conditions

  • Postmenopausal Osteoporosis

Interventions

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.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Unigene Laboratories Inc.

    lead INDUSTRY

Principal Investigators

  • Christence S Teglbjaerg, MD · CCBR

  • Bettina S Nedergaard, MD · CCBR

  • Peter Alexandersen, MD · CCBR

  • Ivo Valter, MD · CCBR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Denmark
  • Estonia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01321723 on ClinicalTrials.gov