A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis

Verified by: Warner Chilcott, April 2011
First Received: October 5, 2007 | Last Updated: May 23, 2011 | Phase: Phase 3 | Start Date: October 2007
Overall Status: Completed | Estimated Enrollment: 923
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The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily...

Brief Summary

Official Title: “A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.”

The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: April 2010

Detailed Clinical Trial Description

The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given daily.

Intervention(s) in this Clinical Trial

  • Drug: risedronate
    • 5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily
  • Drug: risedronate
    • 35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly
  • Drug: risedronate
    • 35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 5 mg Before Breakfast
    • 5 mg / Immediate-release Risedronate (At Least 30 Minutes Before Breakfast)
  • Experimental: 35 mg After Breakfast
    • 35 mg / Delayed-release Risedronate (Immediately Following Breakfast)
  • Experimental: 35 mg Before Breakfast
    • 35 mg / Delayed-release Risedronate (At Least 30 Minutes Before Breakfast)

Outcome Measures for this Clinical Trial

Primary Measures

  • Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population
    • Time Frame: 52 weeks / Endpoint
      Safety Issue?: Yes

Secondary Measures

  • Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population
    • Time Frame: Week 52 / Endpoint
      Safety Issue?: Yes
  • Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population
    • Time Frame: Week 26
      Safety Issue?: Yes
  • Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population
    • Time Frame: Week 52
      Safety Issue?: Yes
  • Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population
    • Time Frame: Week 104
      Safety Issue?: Yes
  • Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population
    • Time Frame: Week 104 / Endpoint
      Safety Issue?: Yes
  • Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population
    • Time Frame: Week 52
      Safety Issue?: Yes
  • Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population
    • Time Frame: Week 52 / Endpoint
      Safety Issue?: Yes
  • Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population
    • Time Frame: Week 52
      Safety Issue?: Yes
  • Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population
    • Time Frame: Week 52 / Endpoint
      Safety Issue?: Yes
  • Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population
    • Time Frame: Week 26
      Safety Issue?: Yes
  • Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population
    • Time Frame: Week 52
      Safety Issue?: Yes
  • Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population
    • Time Frame: Week 52 / Endpoint
      Safety Issue?: Yes
  • Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population
    • Time Frame: Week 104
      Safety Issue?: Yes
  • Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population
    • Time Frame: Week 104 / Endpoint
      Safety Issue?: Yes
  • Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population
    • Time Frame: Week 26
      Safety Issue?: Yes
  • Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population
    • Time Frame: Week 52
      Safety Issue?: Yes
  • Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population
    • Time Frame: Week 52 / Endpoint
      Safety Issue?: Yes
  • Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population
    • Time Frame: Week 104
      Safety Issue?: Yes
  • Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population
    • Time Frame: Week 104 / Endpoint
      Safety Issue?: Yes
  • Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population
    • Time Frame: Week 26
      Safety Issue?: Yes
  • Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population
    • Time Frame: Week 52
      Safety Issue?: Yes
  • Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint
    • Time Frame: Week 52 / Endpoint
      Safety Issue?: Yes
  • Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population
    • Time Frame: Week 104
      Safety Issue?: Yes
  • Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint
    • Time Frame: Week 104 / Endpoint
      Safety Issue?: Yes
  • Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population
    • Time Frame: Week 13
      Safety Issue?: Yes
  • Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population
    • Time Frame: Week 26
      Safety Issue?: Yes
  • Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population
    • Time Frame: Week 52
      Safety Issue?: Yes
  • Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population
    • Time Frame: Week 52 / Endpoint
      Safety Issue?: Yes
  • Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population
    • Time Frame: Week 104
      Safety Issue?: Yes
  • Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population
    • Time Frame: Week 104 / Endpoint
      Safety Issue?: Yes
  • Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population
    • Time Frame: Week 13
      Safety Issue?: Yes
  • Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population
    • Time Frame: Week 26
      Safety Issue?: Yes
  • Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population
    • Time Frame: Week 52
      Safety Issue?: Yes
  • Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population
    • Time Frame: Week 52 / Endpoint
      Safety Issue?: Yes
  • Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population
    • Time Frame: Week 104
      Safety Issue?: Yes
  • Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population
    • Time Frame: Week 104 / Endpoint
      Safety Issue?: Yes
  • Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population
    • Time Frame: Week 13
      Safety Issue?: Yes
  • Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population
    • Time Frame: Week 26
      Safety Issue?: Yes
  • Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population
    • Time Frame: Week 52
      Safety Issue?: Yes
  • Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population
    • Time Frame: Week 52 / Endpoint
      Safety Issue?: Yes
  • Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population
    • Time Frame: Week 104
      Safety Issue?: Yes
  • Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population
    • Time Frame: Week 104 / Endpoint
      Safety Issue?: Yes
  • Number of Patients With at Least One New Fractured Vertebra, Week 52
    • Time Frame: Week 52
      Safety Issue?: Yes
  • Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population
    • Time Frame: Week 52 / Endpoint
      Safety Issue?: Yes
  • Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population
    • Time Frame: Week 104
      Safety Issue?: Yes
  • Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population
    • Time Frame: Week 104 / Endpoint
      Safety Issue?: Yes
  • Number of Patients With No New Fractured Vertebra, Week 52
    • Time Frame: Week 52
      Safety Issue?: Yes
  • Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint
    • Time Frame: Week 52 / Endpoint
      Safety Issue?: Yes
  • Number of Patients With No New Fractured Vertebra, Week 104
    • Time Frame: Week 104
      Safety Issue?: Yes
  • Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint
    • Time Frame: Week 104 / Endpoint
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Female: 50 years of age or older
  • >5 years since last menses natural or surgical
  • have lumbar spine or total hip BMD more that 2.5 SD below the young adult mean, or have lumbar spine or total hip BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture

Exclusion Criteria:

  • history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
  • BMI >32 kg/m
  • use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
  • hypocalcemia or hypercalcemia of any cause
  • markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Warner Chilcott Industry

Overall Clinical Trial Officials and Contacts

Ana Balske, MD, PhD Study Director Procter and Gamble  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00541658

Study ID Number: 2007008

ClinicalTrials.gov Identifier: NCT00541658

Health Authority: United States: Food and Drug Administration

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