Risedronate in Osteopenic Postmenopausal Women

Study Overview
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Brief Summary
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The primary objective of this study is to compare risedronate 35 mg and placebo with respect to the percent change at 12 months for distal radius trabecular bone volume (BV/TV) in osteopenic postmenopausal women, as measured by three-dimensional peripheral quantitative computed tomography (3D pQCT). The secondary objectives are to compare the percent change from Screening/Baseline between the 2 treatment groups for the following measurements: Bone mineral density of the lumbar spine, femoral neck, femoral trochanter, and total proximal femur using a dual energy X-ray absorptiometry (DXA) scan at 12 and 24 months; 3D pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6, 12, and 24 months; and Bone turnover markers (BTMs) of: fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen (CTX 1); serum aminoterminal propeptide of type 1 procollagen (PINP); and urine N-telopeptide cross-links (NTX) at 3, 6, 12, and 24 months.

Official Title
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A Non-invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D Peripheral Quantitative Computed Tomography: A 24 Month, Monocenter Study Comparing Weekly Oral Risedronate 35 mg and Placebo

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: risedronate
* Drug: risedronate placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteopenic, postmenopausal women, between 55 and 75 years of age with a body mass index (BMI) < 30 kg/m² Exclusion Criteria: Clinical or radiological evidence of osteoporosis Severe renal impairment Serum 5-hydroxy vitamin D level < 15 ng/ml History of recent primary hyperparathyroidism or recent thyroid disorder History of any generalized bone disease Current use of glucocorticoids, estrogens, progestins, calcium supplements > 1 g/day, vitamin D supplements > 800 IU/day, parathyroid hormone (PTH), or any bisphosphonate for > 1 month at any time within the past 6 months. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: risedronate<br>* risedronate sodium 35 mg tablets (once a week dose)<br>|
| Placebo Comparator: 2<br> | Drug: risedronate placebo<br>* placebo for risedronate tablets (once a week dose)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy data : 3-D-pQCT Data-Microarchitectural Parameters (Distal Radius BV/TV Measurements) |  | BV/TV percent change from Baseline at distal radius as measured in the non dominant wrist at Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance data :collection of AEs, with special interest for upper gastrointestinal (UGI) AEs and clinical fractures |  | at all visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal