Conditions: Postmenopausal Osteoporosis
Keywords: Osteoporosis Bone Diseases, Metabolic Bone Diseases Bone Density Conservation Agents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 97
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: PTH(1-31) 5 mg tablet, once daily arm 2: Placebo matching tablet, once daily arm 3: Forsteo (teriparatide) 20 mcg SC Injection, once daily

Interventions: intervention 1: PTH analog intervention 2: Placebo intervention 3: Forsteo (Teriparatide)
Intervention descriptions: intervention 1: A recombinant 1-31 amino acid fragment of PTH. intervention 2: None intervention 3: A recombinant 1-34 amino acid fragment of PTH.

Protocol document: