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Nuclear MRI(NMR)in Women at Risk of Fracture Receiving Either Zoledronic Acid or Teriparatide - NCT01153425-19104(Clinical Trial 680971)



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City:  Philadelphia
State:  
PA
Zip Code: 19104
Conditions: Osteoporosis, Osteopenia
Purpose: The purpose of this study is to determine the changes in trabecular bone architecture in women 60 and older with high risk of fracture treated with either teriparatide or zoledronic acid.
Study summary: The overall design is to determine and compare the effect of teriparatide and of zoledronic acid on trabecular architecture by magnetic resonance microimaging of the midshaft tibia. Fifty-six postmenopausal women, aged 60 or older with osteoporosis and/or at increased risk of fracture, will be randomized to receive either teriparatide or zoledronic acid. Both groups will be followed for 24 months. Trabecular microarchitecture, cortical structural parameters, biomechanical parameters and bone mineral density will be examined at 0, 12, and 24 months.
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
Study is available at: University of Pennsylvania
Philadelphia, PA 19104
United States

Primary Contact:
Terry M. Scattergood, RN, MSN
Email: theresa.scattergood@uphs.upenn.edu
Phone: 215-898-5664

Secondary Contact:
Terry Scattergood, RN, MSN
Email: theresa.scattergood@uphs.upenn.edu
Phone: 215-898-5664
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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