Overview

Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method

Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Warner Chilcott
Treatments:
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;