µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis
Condition: Osteoporosis, Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Intervention: Virtual Bone Biopsy; Teriparatide; Zoledronic Acid
Intervention description: 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.; Participants are clinically indicated for treatment.; Participants are clinically indicated for treatment.
Intervention MeSH terms: Zoledronic Acid; Teriparatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Postmenopausal women, ages ≥ 60 years, indicated for treatment with antiresorptive or anabolic drugs due to severe osteoporosis and high risk of fracture.
Masking: None (Open Label)
Enrollment: 33.0
Sex: Female
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Osteoporosis; Osteopenia; Fracture Risk; teriparatide or Forteo; zoledronic acid or Reclast

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.
    

Eligibility criteria:

        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