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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women | Clinical Trials | Clareo Health

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

A Phase I, Partially Blinded, Randomized, Placebo Controlled, Active Comparator Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Post-menopausal Women After Daily Oral Doses of PTH134

NCT01224717•Novartis

View on ClinicalTrials.gov

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.

Eligibility

Age

45 - 80 years

Sex

FEMALE

Healthy Volunteers

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

Locations (4)

Novartis Investigative Site

Aalborg, Denmark

Novartis Investigative Site

Ballerup Municipality, Denmark

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Munich, Germany

Key Dates

Start Date

September 1, 2010

Primary Completion Date

April 1, 2011

Last Updated

May 13, 2011

Enrollment

104

ACTUAL participants

Conditions

Post-menopausal Osteoporosis

Interventions

PTH134

DRUG

Placebo

DRUG

Forsteo

DRUG