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Bone Water and Mineralization Measured by Nuclear Magnetic Resonance

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Study Overview

Post-menopausal osteoporosis is a major public health issue affecting millions of women. However, the microstructural implications of the disorder on cortical bone, the dominant bone type of the skeleton, are poorly understood and currently cannot be evaluated in vivo. This study, which utilizes new quantitative MRI methods, provides a path toward both clinical assessment of cortical bone health and the effectiveness of drug intervention in patients with osteoporosis. All subjects meeting the enrollment criteria at screening will receive bone mineral density scans of the lumbar vertebrae (lateral and AP) and proximal femur quantified by DXA and 3D bone mineral density scans of the mid-shaft tibia by pQCT and acquisition of MR images of the left mid-shaft tibia. Comprehensive metabolic panel (CMP), 25-OH Vitamin D, FSH (at baseline only), parathyroid hormone, and HbA1c will be checked at baseline, 12 and 24 months. Subjects with osteoporosis will receive zoledronic acid infusion annually. Labs will be done at the screening visit and at the 12 month visit to ensure that subjects are healthy to receive infusion. All study participants will receive 1200 mg of calcium and 1000 units of Vitamin D. DXA, pQCT and MRI will be repeated at 12 and 24 months.

Study Description

Requirements, Group 1:
Post-menopausal, osteoporotic women (group 1): 50-75 years old,  BMD T-score less than or equal to -2.5 (at either spine, total hip or femoral neck), 25 vitamin D level greater than 20 ng/ml, serum FSH concentrations of 25 mIU/mL, BMI less than or equal to 30.

Study visits, Group 1: Screening visit (DXA, labs, pQCT, height and weight, urine pregnancy test), Baseline visit (MRI, zoledronic acid infusioin, supplements), 3/6/9 month telephone visit, 12 month visit 1 (height and weight, labs, DXA, pQCT), 12 month visit 2 (MRI, zoledronic acid infusion, supplements), 15/18/21 month telephone visit, 24 month visit (height and weight, labs, DXA, pQCT MRI) **weekly telephone adherence

Requirements, Group 2:
Post-menopausal, control women (group 2): 50-75 years old,  BMD T-score greater than -2.5 (at either spine, total hip or femoral neck), 25 vitamin D level greater than 20 ng/ml, serum FSH concentrations of 25 mIU/mL, BMI less than or equal to 30.

Study visits, Group 2: Screening visit (DXA, labs, pQCT, height and weight, urine pregnancy test), Baseline visit (MRI, supplements), 6 month telephone visit, 12 month visit (height and weight, labs, DXA, pQCT, MRI, supplements), 18 month telephone visit, 24 month visit (height and weight, labs, DXA, pQCT MRI) **weekly telephone adherence


**Weekly telephone adherence- brief phone call/email from coordinator to discuss compliance of taking supplements

  • Study Identifier: 825750

Recruitment Status

Open

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