µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis

Phase 4

Completed

Conditions: Osteoporosis, Osteopenia

Interventions: Other: Virtual Bone Biopsy
Drug: Teriparatide
Drug: Zoledronic Acid

Registration Number: NCT01153425

Lead Sponsor: University of Pennsylvania

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 33

Inclusion Criteria

Women
Age ≥ 60 years
Bone mineral density T-score of either the spine (L1-L4), total hip or femoral neck of ≤ - 2.0, or has a history of an osteoporotic fracture

Exclusion Criteria

Previous treatment with pamidronate, ibandronate, of more than 2 doses in 2 years and of zoledronic acid at any time
Previous treatment with teriparatide, alendronate or risedronate of more than 2 months in the last 24 months
Previous treatment with calcitonin within the previous year; previous treatment with an estrogen or selective estrogen modulator will not exclude a potential subject unless she has been taking it for < 1 year (a woman who discontinued estrogen or a selective estrogen receptor within the previous year will also be excluded)
Other diseases known to affect bone, such as Paget's disease, Cushing's disease, hyperthyroidism, hyperparathyroidism, bone cancer and metastases to bone, and vitamin D deficiency
Medications known to affect bone, such as anticonvulsants, high dose glucocorticoids (20 mg/day or more > 2 weeks within the previous 6 months)
Current alcohol use > 3 drinks/day
Untreated or unstable cardiac, pulmonary, liver (SGOT > 2X upper limit of normal) or renal disease (creatinine > 1.2 mg/dL) or uncontrolled diabetes (hemoglobin A1C > 8.0)
Prior radiation therapy to the skeleton
Cardiac pacemakers, ferromagnetic implants or brain aneurysm clips
Claustrophobia
Subjects whose initial MRI is of poor quality due to motion artifact will be asked to repeat the examination; if a repeat MRI is of poor quality due to motion artifact, the subject will be excluded from the study
Abnormalities of the which delay esophageal emptying such as stricture or achalasia
Inability to stand or sit upright for at least 30 minutes
Hypocalcemia
Uric acid level >7.5ml/dl
Subjects with metallic objects in their bodies

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teriparatide (Forteo)	Virtual Bone Biopsy	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.
Zoledronic Acid (Reclast)	Virtual Bone Biopsy	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.
Teriparatide (Forteo)	Teriparatide	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.
Zoledronic Acid (Reclast)	Zoledronic Acid	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Change in Trabecular Surface-to-curve Ratio	Change between baseline and 12 months	Ratio of the volume densities of surface (S) and curve (C)-type voxels, S/C

Secondary Outcome Measures