Conditions: Osteoporosis, Osteopenia
Keywords: Osteoporosis Osteopenia Fracture Risk teriparatide or Forteo zoledronic acid or Reclast
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 33
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 20 µg of Teriparatide will be self-injected subcutaneously once a day for 12 months and an MRI at 3T ('Virtual Bone Biopsy') will be performed at 0 and 12 months. arm 2: 5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI at 3T ('Virtual Bone Biopsy) will be performed at 0 and 12 months.

Interventions: intervention 1: Virtual Bone Biopsy intervention 2: Teriparatide intervention 3: Zoledronic Acid
Intervention descriptions: intervention 1: 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. intervention 2: Participants are clinically indicated for treatment. intervention 3: Participants are clinically indicated for treatment.

Protocol document: