Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

Phase 3

Completed

• Conditions: Osteoporosis, Postmenopausal

• Registration Number: NCT00353080
• Lead Sponsor: Sanofi

Brief Summary

To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women

To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption

To confirm general safety of 5 mg daily risedronate as compared to placebo

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2006-07-13
• Study First Submitted QC: 2006-07-13
• Study First Posted: 2006-07-17
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-11
• Last Update Posted: 2009-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 171

Inclusion Criteria

• Ambulatory, healthy postmenopausal women with

  • Natural menopause and more than 5 years after their last menstrual period
  • or surgical menopause and more than 5 years after surgery
  • osteopenia (lumbar spine T score between 1 and 2.5 SD below the mean value in normal young women).

• With at least one risk factor for osteoporosis

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Exclusion Criteria

• Women who have received hormone replacement therapy (with estrogen and/or progestogen and/or androgen) or raloxifene within 3 months before visit 2 or calcitonin or calcitriol within 4 weeks before visit 2

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA.

Secondary Outcome Measures

Name	Time	Method
Percent changes in proximal femur BMD from baseline at month 12 and 24 (DXA)
Percent of responders (subjects with a positive change in lumbar spine BMD from baseline)at Month 12 and 24
Percent changes in bone turnover markers after 12 and 24 months of treatment
Physical examination and hematology tests before and after 12 and 24 months of treatment;Serum Chemistry before and after 6, 12 and 24 months of treatment
Occurrence of adverse events at each visit with special interest for upper gastro-intestinal events

Trial Locations

Locations (1)

Sanofi-Aventis; 🇸🇪 Stockholm, Sweden