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

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.

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.