NCT00557310

A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide

The Effects of Teriparatide on Bone Microarchitecture as Determined by High Resolution Magnetic Resonance Imaging and Digital Topological Analysis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to use imaging technologies to demonstrate the effects of teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women with osteoporosis.

Detailed description

As teriparatide is approved for up to 24 months of treatment in the US, patients will be given the option to continue in a 6-month extension phase upon completion of 18 months of teriparatide treatment. This extension will allow for collection of additional bone quality data. In Canada, the use of teriparatide is currently approved for 18 months. Patients in Canada may be given the opportunity to participate in the 6-month extension phase, contingent upon Health Canada approval of the use of teriparatide treatment for 24 months.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	teriparatide	20 mcg teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-10-01
• Completion: 2011-05-01
• First posted: 2007-11-14
• Last updated: 2011-11-11
• Results posted: 2011-11-11

Locations

6 sites across 2 countries: United States, Canada