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.
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 sensitivity of the technology to detect a difference between those treated with risedronate 35mg OAW (once a week) or placebo. Early phase postmenopausal women with osteopenia have been chosen because they have a more rapid and higher level of bone loss during the first few years of the menopause.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
161
oral weekly for one year
35 mg risedronate, once a week for one year
Research Facility
Buenos Aires, Buenos Aires, Argentina
Research Facility
Heidelberg, Victoria, Australia
Research Facility
Toronto, Ontario, Canada
Research Facility
Lyon, Lyon, France
Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Lumbar Spine BMD, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Femoral Neck BMD, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Facility
Saint-Etienne, Saint-Etienne, France
Research Facility
Toulouse, Toulouse, France
Research Facility
Berlin, State of Berlin, Germany
Research Facility
Geneva, Canton of Geneva, Switzerland
Research Facility
Cambridge, Cambridge, United Kingdom
Greater Trochanter BMD, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12
Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12
ELISA / enzyme-linked immunosorbent assay method by central lab
Time frame: Baseline and Month 12
Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12
Electrochemiluminescence assay method by central lab
Time frame: Baseline and Month 12
Height, Percent Change From Baseline to Month 12
Time frame: Baseline and Month 12