Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

A Two-year, Multicenter, Double-blind, Randomized, Placebo-controlled and Parallel Group Study of Oral Risedronate 5 mg Daily in the Prevention of Osteoporosis in Osteopenic Postmenopausal Women (More Than 5 Years Postmenopausal)

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

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