Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women
A Double Blind, Randomized, Repeat Dose Parallel Group Study of Recombinant Human Parathyroid Hormone Analog Tablets, or Placebo Tablets, Compared to Open Label Forsteo® in Postmenopausal Women With Osteoporosis
Lead SponsorUnigene Laboratories Inc.
StatusCompleted Results Posted
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.
The choice of a 24-week treatment period was based on published studies of PTH which demonstrate its potential to produce a statistically significant increase in BMD in patients with postmenopausal osteoporosis within that observation period.
A recombinant 1-31 amino acid fragment of PTH.
A recombinant 1-34 amino acid fragment of PTH.
Placebo matching tablet, once daily
PTH(1-31) 5 mg tablet, once daily
Forsteo (teriparatide) 20 mcg SC Injection, once daily
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
|Event Type||Organ System||Event Term||Forsteo (Teriparatide)||PTH Analog Tablets||Placebo|
Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used.
AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours)