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Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00358176
First received: July 28, 2006
Last updated: December 11, 2009
Last verified: December 2009

July 28, 2006
December 11, 2009
July 2004
March 2007   (final data collection date for primary outcome measure)
  • Percent change from baseline in lumbar spine bone mineral density (BMD) at
  • Month 12 measured by dual-energy X-ray absorptiometry (DXA).
Same as current
Complete list of historical versions of study NCT00358176 on ClinicalTrials.gov Archive Site
  • Efficacy:Percent change from baseline in Lumbar spine BMD at times other than Month 12, Proximal femur BMD and Bone turnover markers.
  • Safety: AEs, clinical laboratory values, bone biopsies.
  • Intact serum parathyroid hormone (PTH 1-84)before treatment and after 3, 12 and 24 months of treatment in approximately 25% of randomly selected trial participants.
  • Physical examination before treatment and after 12 and 24 months of treatment.
Same as current
Not Provided
Not Provided
 
Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women
A Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Noninferiority Study Comparing 75mg Risedronate Dosed on 2 Consecutive Days Monthly With 5mg Daily Risedronate in the Treatment of Postmenopausal Osteoporosis as Assessed Over 24 Months.

To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis.

To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption.

To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoporosis Postmenopausal
Drug: Risedronate (HMR4003)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1231
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

Subjects meeting all of the following criteria were considered for enrollment into the study :

·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 (blood hormone tests required for subjects less than 65 years of age who had uterus removed without removal of ovaries at time of surgery).

Osteoporosis (lumbar spine T-score more than 2.5 SD below the mean value in normal young women or more than 2.0 SD below the mean value in normal young women and at least 1 fracture of a vertebra (thoracic-lumbar T4-L4)).

Exclusion Criteria:

Subjects with any of the following criteria were not considered for enrollment into the study :

·Women who have received hormone replacement therapy (with estrogen by mouth and/or progestogen and/or androgen) or raloxifene, or other bone active drugs, such as calcitonin, calcitriol/calcidiol/alfacalcidol, parathyroid hormone or any bisphosphonate within 3 months before first dose of study medication.

Female
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Canada,   Czech Republic,   France,   Lebanon,   Poland,   South Africa,   Turkey,   United Kingdom
 
NCT00358176
EFC6063, HMR4003M/3001
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Procter and Gamble
Study Director: ICD CSD Sanofi
Sanofi
December 2009

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