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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women

NCT01224717 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2011-05-13

No results posted yet for this study

Summary

This study is designed to provide information about the bone-anabolic response of PTH134 when administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the active ingredient in PTH134.

Conditions

  • Post-menopausal Osteoporosis

Interventions

DRUG

PTH134

DRUG

Placebo

DRUG

Forsteo

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

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
2010-09-30
Primary Completion
2011-04-30

Countries

  • Denmark
  • Germany

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 NCT01224717 on ClinicalTrials.gov