Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2009

Intervention(s) in this Clinical Trial

• Drug: risedronate
  • risedronate sodium 35 mg tablets (once a week dose)
• Drug: risedronate placebo
  • placebo for risedronate tablets (once a week dose)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Efficacy data : 3-D-pQCT Data—Microarchitectural Parameters (Distal Radius BV/TV Measurements)
  • Time Frame: BV/TV percent change from Baseline at distal radius as measured in the non dominant wrist at Month 12
    Safety Issue?: No
• Tolerance data :collection of AEs, with special interest for upper gastrointestinal (UGI) AEs and clinical fractures at all visits
  • Time Frame: throughout the study
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

M Couderc, Dr Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00345644

Study ID Number: HMR4003B_3507

ClinicalTrials.gov Identifier: NCT00345644

Health Authority: France: Afssaps - French Health Products Safety Agency