Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

Sanofi171 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

171

Conditions

Osteoporosis, Postmenopausal

Interventions

risedronate (HMR4003)DRUG

Eligibility

Sex: FEMALEMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (5)

Sanofi-Aventis

Helsinki, Finland

Sanofi-Aventis

Gouda, Netherlands

Sanofi-Aventis

Oslo, Norway

Sanofi-Aventis

Madrid, Spain

Sanofi-Aventis

Stockholm, Sweden

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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