Skip to main content
OpenTrials
Completed

NCT Number: NCT00353080

Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis, Postmenopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis, Helsinki, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risedronate (HMR4003)

Drug

Primary outcomes

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

Secondary outcomes

  1. Percent changes in proximal femur BMD from baseline at month 12 and 24 (DXA)

  2. Percent of responders (subjects with a positive change in lumbar spine BMD from baseline)at Month 12 and 24

  3. Percent changes in bone turnover markers after 12 and 24 months of treatment

  4. 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

  5. Occurrence of adverse events at each visit with special interest for upper gastro-intestinal events

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Procter and Gamble

Registry information

Official study title

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)

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Jul 17, 2006
Registry last updated
Dec 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.