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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Non-Invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D-Peripheral Quantitative Computed Tomography (3D-pQCT)

Conditions
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Osteopenia

Intervention / Treatment
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* Drug: Placebo comparator
* Drug: risedronate


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo dose | Drug: Placebo comparator<br>* oral weekly for one year<br>|
| Experimental: Risedronate<br>35 mg risedronate, orally, once weekly | Drug: risedronate<br>* 35 mg risedronate, once a week for one year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12 |  | Baseline and Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12 |  | Baseline and Month 12 | 
| Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12 |  | Baseline and Month 12 | 
| Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12 |  | Baseline and Month 12 | 
| Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12 |  | Baseline and Month 12 | 
| Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12 |  | Baseline and Month 12 | 
| Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12 |  | Baseline and Month 12 | 
| Lumbar Spine BMD, Percent Change From Baseline to Month 12 |  | Baseline and Month 12 | 
| Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12 |  | Baseline and Month 12 | 
| Femoral Neck BMD, Percent Change From Baseline to Month 12 |  | Baseline and Month 12 | 
| Greater Trochanter BMD, Percent Change From Baseline to Month 12 |  | 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 | Baseline and Month 12 | 
| Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12 | Electrochemiluminescence assay method by central lab | Baseline and Month 12 | 
| Height, Percent Change From Baseline to Month 12 |  | Baseline and Month 12 |