The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral Quantitative Computed Tomography) technology to detect minute changes in bone microarchitecture.
Who can participate
Age range40 Years – 55 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* cessation of menstruation (surgical or natural) between 6 and 36 months prior to study enrollment;
* osteopenic
* must have at least 1 evaluable radius and tibia, without history of fracture (traumatic or atraumatic)
* BMI (body mass index) between 18 and 28 kg/m2 inclusive;
Exclusion Criteria:
* history of any generalized bone disease, including hyperparathyroidism, Paget's disease of bone, renal osteodystrophy, or any other acquired or congenital bone disease; or any known condition that would interfere with the assessment of DXA (dual-energy X-ray absorptiometry) at either the lumbar spine (3 non-evaluable lumbar vertebrae at lumbar spine L1 - L4) or the femoral neck.
* clinical or radiological evidence of osteoporosis, such as atraumatic vertebral compression fracture (\* 20% reduction in anterior-to-posterior or middle-to-posterior height ratio; or 20% reduction of the anterior, middle, and/or posterior height as compared with the adjacent vertebrae) documented by spinal X ray or a history of osteoporosis-related atraumatic fracture of the hip or of the wrist;
* glucocorticoid-induced osteopenia;
* previous bisphosphonate therapy;
What they're measuring
1
Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12