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Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00353080
Recruitment Status : Completed
First Posted : July 17, 2006
Last Update Posted : December 15, 2009
Procter and Gamble
Information provided by:

Brief Summary:

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 or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Drug: risedronate (HMR4003) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : December 2002
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00353080

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Helsinki, Finland
Gouda, Netherlands
Oslo, Norway
Madrid, Spain
Stockholm, Sweden
Sponsors and Collaborators
Procter and Gamble
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Principal Investigator: Välimäki Matti, MD Division of Endocrinology, Helsinki University Central Hospital, Helsinki, Finland
Publications of Results:
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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00353080    
Other Study ID Numbers: EFC6064
First Posted: July 17, 2006    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: December 2009
Keywords provided by Sanofi:
Prevention of postmenopausal osteoporosis
Additional relevant MeSH terms:
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Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Risedronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents