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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2007

Interventions

  • Drug: Risedronate (HMR4003)

Clinical Trial Outcome Measures

Primary Measures

  • Percent change from baseline in lumbar spine bone mineral density (BMD) at
  • Month 12 measured by dual-energy X-ray absorptiometry (DXA).

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Collaborator
    • Procter and Gamble
  • Provider of Information About this Clinical Study
    • ICD Study Director, sanofi-aventis
  • Overall Official(s)
    • ICD CSD, Study Director, Sanofi

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