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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00541658
First received: October 5, 2007
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: risedronate
Phase 3

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
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.

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population [ Time Frame: 52 weeks / Endpoint ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population [ Time Frame: Week 26 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population [ Time Frame: Week 104 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population [ Time Frame: Week 104 / Endpoint ] [ Designated as safety issue: Yes ]
  • Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
    Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

  • Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population [ Time Frame: Week 52 / Endpoint ] [ Designated as safety issue: Yes ]
    Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

  • Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
    Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

  • Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population [ Time Frame: Week 52 / Endpoint ] [ Designated as safety issue: Yes ]
    Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

  • Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population [ Time Frame: Week 26 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population [ Time Frame: Week 52 / Endpoint ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population [ Time Frame: Week 104 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population [ Time Frame: Week 104 / Endpoint ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population [ Time Frame: Week 26 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population [ Time Frame: Week 52 / Endpoint ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population [ Time Frame: Week 104 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population [ Time Frame: Week 104 / Endpoint ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population [ Time Frame: Week 26 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint [ Time Frame: Week 52 / Endpoint ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population [ Time Frame: Week 104 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint [ Time Frame: Week 104 / Endpoint ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population [ Time Frame: Week 13 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population [ Time Frame: Week 26 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population [ Time Frame: Week 52 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population [ Time Frame: Week 104 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population [ Time Frame: Week 13 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population [ Time Frame: Week 26 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population [ Time Frame: Week 52 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population [ Time Frame: Week 104 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population [ Time Frame: Week 13 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population [ Time Frame: Week 26 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population [ Time Frame: Week 52 / Endpoint ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population [ Time Frame: Week 104 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population [ Time Frame: Week 104 / Endpoint ] [ Designated as safety issue: Yes ]
  • Number of Patients With at Least One New Fractured Vertebra, Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population [ Time Frame: Week 52 / Endpoint ] [ Designated as safety issue: Yes ]
  • Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population [ Time Frame: Week 104 ] [ Designated as safety issue: Yes ]
  • Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population [ Time Frame: Week 104 / Endpoint ] [ Designated as safety issue: Yes ]
  • Number of Patients With No New Fractured Vertebra, Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint [ Time Frame: Week 52 / Endpoint ] [ Designated as safety issue: Yes ]
  • Number of Patients With No New Fractured Vertebra, Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: Yes ]
  • Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint [ Time Frame: Week 104 / Endpoint ] [ Designated as safety issue: Yes ]

Enrollment: 923
Study Start Date: October 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 5 mg Before Breakfast
5 mg / Immediate-release Risedronate (At Least 30 Minutes Before Breakfast)
Drug: risedronate
5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily
Other Name: IRBB
Experimental: 35 mg After Breakfast
35 mg / Delayed-release Risedronate (Immediately Following Breakfast)
Drug: risedronate
35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly
Other Name: DRFB
Experimental: 35 mg Before Breakfast
35 mg / Delayed-release Risedronate (At Least 30 Minutes Before Breakfast)
Drug: risedronate
35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly
Other Name: DRBB

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541658

  Show 45 Study Locations
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Ana Balske, MD, PhD Procter and Gamble
  More Information

No publications provided by Warner Chilcott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00541658     History of Changes
Other Study ID Numbers: 2007008
Study First Received: October 5, 2007
Results First Received: April 13, 2011
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Etidronic Acid
Risedronic acid
Bone Density Conservation Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014