NCT01153425

µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis

NMR Imaging and Stereological Analysis of Trabecular Bone in Female Subjects 60 and Older at Risk of Fracture Receiving Either Zoledronic Acid or Teriparatide

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to apply a novel advanced magnetic resonance imaging methodology to evaluate the response to drug intervention involving two treatment arms of postmenopausal participants with osteoporosis, randomized into either a teriparatide (Forteo™) or zoledronic acid (Reclast™) group.

Detailed description

The overall design is to determine and compare the effect of teriparatide and of zoledronic acid on trabecular architecture by magnetic resonance imaging of the midshaft tibia. Post-menopausal women, aged 60 or older with osteoporosis and/or at increased risk of fracture, will be randomized to receive either teriparatide or zoledronic acid. Trabecular microarchitecture, biomechanical parameters and bone mineral density will be examined at 0 and 12 months at 3T MRI.

Conditions

• Osteoporosis, Osteopenia

Interventions

Type	Name	Description
OTHER	Virtual Bone Biopsy	MRI technology allowing generation of 3D images with considerably smaller voxel size than previous technology through the use of novel pulse sequences and advanced interpolation techniques.
DRUG	Teriparatide	Participants are clinically indicated for treatment.
DRUG	Zoledronic Acid	Participants are clinically indicated for treatment.

Timeline

• Start date: 2008-07-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-06-30
• Last updated: 2017-08-04
• Results posted: 2017-08-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study