Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

Sanofi

Status and phase

Completed

Phase 3

Conditions

Osteoporosis, Postmenopausal

Treatments

Drug: risedronate (HMR4003)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00353080

HMR4003B/3001

EFC6064

Details and patient eligibility

About

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

Enrollment

171 patients

Sex

Female

Ages

45+ years old

Volunteers

No Healthy Volunteers

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