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

Novartis

Status and phase: Completed; Phase 1

Conditions: Post-menopausal Osteoporosis

Treatments: Drug: PTH134; Drug: Forsteo; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01224717

2009-015933-64 (EudraCT Number)

CPTH134A2102

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: Female

Ages: 45 to 80 years old

Volunteers: No 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
• Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 3 patient groups, including a placebo group

PTH134

Experimental group

Treatment:

Drug: PTH134

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Forsteo

Active Comparator group

Treatment:

Drug: Forsteo