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Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

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

July 13, 2006
December 11, 2009
December 2002
April 2005   (final data collection date for primary outcome measure)
Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA.
Same as current
Complete list of historical versions of study NCT00353080 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
 
 
Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women
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)

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
 
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Osteoporosis, Postmenopausal
Drug: risedronate (HMR4003)
 
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.
 
Completed
171
April 2005
April 2005   (final data collection date for primary outcome measure)

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
Female
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Netherlands,   Norway,   Spain,   Sweden
 
NCT00353080
EFC6064, HMR4003B/3001
 
ICD Study Director, sanofi-aventis
Sanofi-Aventis
Procter and Gamble
Principal Investigator: Välimäki Matti, MD Division of Endocrinology, Helsinki University Central Hospital, Helsinki, Finland
Sanofi-Aventis
December 2009

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