Text Size

Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00353080
First received: July 13, 2006
Last updated: December 11, 2009
Last verified: December 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Osteoporosis, Postmenopausal
 Drug: risedronate (HMR4003)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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

Secondary Outcome Measures:
  • 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

Enrollment: 171
Study Start Date: December 2002
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00353080

Locations
Finland
Sanofi-Aventis
Helsinki, Finland
Netherlands
Sanofi-Aventis
Gouda, Netherlands
Norway
Sanofi-Aventis
Oslo, Norway
Spain
Sanofi-Aventis
Madrid, Spain
Sweden
Sanofi-Aventis
Stockholm, Sweden
Sponsors and Collaborators
Sanofi
Procter and Gamble
Investigators
Principal Investigator: Välimäki Matti, MD Division of Endocrinology, Helsinki University Central Hospital, Helsinki, Finland
  More Information

Publications:

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00353080     History of Changes
Other Study ID Numbers: EFC6064, HMR4003B/3001
Study First Received: July 13, 2006
Last Updated: December 11, 2009
Health Authority: Finland: Finnish Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency

Keywords provided by Sanofi:
Prevention of postmenopausal osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Bone Density Conservation Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013