NCT00583518

STEP: Study of Imaging Techniques (ImaTx and DXA) in Postmenopausal Women With OstEoporosis Using Preotact (FP-008-ES)

Open Label, Multi-centre, Longitudinal, Prospective, Phase IV Clinical Trial to Compare Two Image Technologies (ImaTx and DXA) Assessing the Anabolic Effects of PTH(1-84) in Postmenopausal Women With Primary Osteoporosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Nycomed · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to explore the relationship between a new image technology (ImaTx), that analyzes the trabecular structure of the bone using digitized radiographs and the bone mineral density (BMD) measured by Dual X-ray Absorptiometry (DXA) in the lumbar spine of postmenopausal (PM) women with osteoporosis (OP) after treatment with PTH (1-84).

Conditions

• Postmenopausal Women With Primary Osteoporosis

Interventions

Type	Name	Description
DRUG	Parathyroid hormone (PTH)	Postmenopausal women with primary osteoporosis

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-11-01
• Completion: 2012-02-01
• First posted: 2007-12-31
• Last updated: 2012-05-07

Locations

1 site across 1 country: Denmark