Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Procter and Gamble
• Treatments: Etidronic Acid; Risedronate Sodium; Risedronic Acid

Criteria

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

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