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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Teriparatide

Criteria

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

• Other protocol-defined inclusion/exclusion criteria apply.