Overview
Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method
Status:
Completed
Completed
Trial end date:
2009-09-01
2009-09-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Warner ChilcottTreatments:
Etidronic Acid
Risedronate Sodium
Risedronic Acid
Criteria
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;