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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01321723

Postmenopausal Osteoporosis

COMPLETED PHASE2

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects

NCT00676312

Postmenopausal Osteoporosis

COMPLETED PHASE1

Nasally and sc Administered Teriparatide in Healthy Volunteers

NCT01913834

Osteoporosis

UNKNOWN PHASE1

The Effects of Therapy With Teriparatide on Vascular Compliance and Osteoprotegerin/RANKL

NCT00347737

Osteoporosis

WITHDRAWN NA

Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action

NCT01293292

Osteoporosis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-menopausal Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PTH134

Group Type EXPERIMENTAL

PTH134

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Forsteo

Group Type ACTIVE_COMPARATOR

Forsteo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PTH134

Intervention Type DRUG

Placebo

Intervention Type DRUG

Forsteo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Post-menopausal women osteoporotic/osteopenic with an additional risk factor 45 to 80 years old

Exclusion Criteria

* Use of estrogen or hormone replacement therapy
* Use of parathormone or parathormone fragments, calcitonin, aluminum supplements, within 12 months prior to first dose.
* Use of bisphosphonates and strontium ranelate
* Cancer or history of malignancy of any organ system
* Any radiation therapy to the skeleton.
* Any known clinically significant disease affecting calcium metabolism. Any history of metabolic disorders including Paget's disease, osteogenesis imperfecta, or osteomalacia.
* History or clinical evidence of any impairment of thyroid function

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No