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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study is designed to provide information about the bone anabolic properties and absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of 24 weeks to postmenopausal women with osteoporosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Unigene Laboratories Inc.
• Collaborator: GlaxoSmithKline
• Treatments: Bone Density Conservation Agents; Teriparatide

Criteria

Inclusion Criteria:

• Healthy postmenopausal women (45-80 years old) with a diagnosis of osteoporosis

Exclusion Criteria:

• Use of estrogen or hormone replacement therapy

• Use of bisphosphonates, strontium ranelate or denosumab

• Use of parathyroid analogues or other bone metabolic agents

• Medical conditions which might alter bone metabolism

• Any known clinically significant disease affecting calcium metabolism or history of metabolic disorders including Paget's disease, osteogenesis imperfecta, or osteomalacia

• Impairment of thyroid function