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Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT00353080
Recruitment Status : Completed
First Posted : July 17, 2006
Last Update Posted : December 15, 2009
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE July 13, 2006
First Posted Date  ICMJE July 17, 2006
Last Update Posted Date December 15, 2009
Study Start Date  ICMJE December 2002
Actual Primary Completion Date April 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2006)
Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00353080 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women
Official Title  ICMJE 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)
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Osteoporosis, Postmenopausal
Intervention  ICMJE Drug: risedronate (HMR4003)
Study Arms  ICMJE Not Provided
Publications * Välimäki MJ, Farrerons-Minguella J, Halse J, Kröger H, Maroni M, Mulder H, Muñoz-Torres M, Sääf M, Snorre Øfjord E. Effects of risedronate 5 mg/d on bone mineral density and bone turnover markers in late-postmenopausal women with osteopenia: a multinational, 24-month, randomized, double-blind, placebo-controlled, parallel-group, phase III trial. Clin Ther. 2007 Sep;29(9):1937-49.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2006)
171
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2005
Actual Primary Completion Date April 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden,   Finland,   Netherlands,   Norway,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00353080
Other Study ID Numbers  ICMJE EFC6064
HMR4003B/3001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ICD Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Procter and Gamble
Investigators  ICMJE
Principal Investigator: Välimäki Matti, MD Division of Endocrinology, Helsinki University Central Hospital, Helsinki, Finland
PRS Account Sanofi
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP