Status:
COMPLETED
Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method
Lead Sponsor:
Warner Chilcott
Conditions:
Osteopenia
Eligibility:
FEMALE
40-55 years
Phase:
PHASE3
Brief 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.
Detailed Description
The 3D-pQCT equipment allows the evaluation of changes occurring within the bone at "microarchitecture" level, without the need for invasive bone biopsies. The primary objective is to evaluate the sen...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT00386360
Start Date
April 1 2006
End Date
September 1 2009
Last Update
January 11 2012
Active Locations (9)
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1
Research Facility
Buenos Aires, Buenos Aires, Argentina, C1012AAR
2
Research Facility
Heidelberg, Victoria, Australia, 3081
3
Research Facility
Toronto, Ontario, Canada, M5G 2C4
4
Research Facility
Lyon, Lyon, France