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

Primary Purpose

Postmenopausal Osteoporosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
risedronate
risedronate
risedronate
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

5 mg Before Breakfast

35 mg After Breakfast

35 mg Before Breakfast

Arm Description

5 mg / Immediate-release Risedronate (At Least 30 Minutes Before Breakfast)

35 mg / Delayed-release Risedronate (Immediately Following Breakfast)

35 mg / Delayed-release Risedronate (At Least 30 Minutes Before Breakfast)

Outcomes

Primary Outcome Measures

Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2007
Last Updated
April 15, 2013
Sponsor
Warner Chilcott
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1. Study Identification

Unique Protocol Identification Number
NCT00541658
Brief Title
A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
923 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 mg Before Breakfast
Arm Type
Active Comparator
Arm Description
5 mg / Immediate-release Risedronate (At Least 30 Minutes Before Breakfast)
Arm Title
35 mg After Breakfast
Arm Type
Experimental
Arm Description
35 mg / Delayed-release Risedronate (Immediately Following Breakfast)
Arm Title
35 mg Before Breakfast
Arm Type
Experimental
Arm Description
35 mg / Delayed-release Risedronate (At Least 30 Minutes Before Breakfast)
Intervention Type
Drug
Intervention Name(s)
risedronate
Other Intervention Name(s)
IRBB
Intervention Description
5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily
Intervention Type
Drug
Intervention Name(s)
risedronate
Other Intervention Name(s)
DRFB
Intervention Description
35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly
Intervention Type
Drug
Intervention Name(s)
risedronate
Other Intervention Name(s)
DRBB
Intervention Description
35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly
Primary Outcome Measure Information:
Title
Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population
Time Frame
52 weeks / Endpoint
Secondary Outcome Measure Information:
Title
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
Title
Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population
Time Frame
Week 26
Title
Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population
Time Frame
Week 52
Title
Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population
Time Frame
Week 104
Title
Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population
Time Frame
Week 104 / Endpoint
Title
Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population
Description
Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
Time Frame
Week 52
Title
Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population
Description
Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
Time Frame
Week 52 / Endpoint
Title
Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population
Description
Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
Time Frame
Week 52
Title
Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population
Description
Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
Time Frame
Week 52 / Endpoint
Title
Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population
Time Frame
Week 26
Title
Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population
Time Frame
Week 52
Title
Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population
Time Frame
Week 52 / Endpoint
Title
Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population
Time Frame
Week 104
Title
Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population
Time Frame
Week 104 / Endpoint
Title
Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population
Time Frame
Week 26
Title
Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population
Time Frame
Week 52
Title
Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population
Time Frame
Week 52 / Endpoint
Title
Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population
Time Frame
Week 104
Title
Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population
Time Frame
Week 104 / Endpoint
Title
Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population
Time Frame
Week 26
Title
Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population
Time Frame
Week 52
Title
Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint
Time Frame
Week 52 / Endpoint
Title
Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population
Time Frame
Week 104
Title
Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint
Time Frame
Week 104 / Endpoint
Title
Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population
Time Frame
Week 13
Title
Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population
Time Frame
Week 26
Title
Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population
Time Frame
Week 52
Title
Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population
Time Frame
Week 52 / Endpoint
Title
Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population
Time Frame
Week 104
Title
Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population
Time Frame
Week 104 / Endpoint
Title
Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population
Time Frame
Week 13
Title
Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population
Time Frame
Week 26
Title
Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population
Time Frame
Week 52
Title
Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population
Time Frame
Week 52 / Endpoint
Title
Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population
Time Frame
Week 104
Title
Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population
Time Frame
Week 104 / Endpoint
Title
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population
Time Frame
Week 13
Title
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population
Time Frame
Week 26
Title
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population
Time Frame
Week 52
Title
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population
Time Frame
Week 52 / Endpoint
Title
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population
Time Frame
Week 104
Title
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population
Time Frame
Week 104 / Endpoint
Title
Number of Patients With at Least One New Fractured Vertebra, Week 52
Time Frame
Week 52
Title
Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population
Time Frame
Week 52 / Endpoint
Title
Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population
Time Frame
Week 104
Title
Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population
Time Frame
Week 104 / Endpoint
Title
Number of Patients With No New Fractured Vertebra, Week 52
Time Frame
Week 52
Title
Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint
Time Frame
Week 52 / Endpoint
Title
Number of Patients With No New Fractured Vertebra, Week 104
Time Frame
Week 104
Title
Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint
Time Frame
Week 104 / Endpoint

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Balske, MD, PhD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Oakland
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Facility
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Research Site
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Research Site
City
Lakewood
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Leesburg
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Melbourne
State/Province
Florida
Country
United States
Facility Name
Research Site
City
South Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Gainesville
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Champaign
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Brockton
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Buenos Aires
Country
Argentina
Facility Name
Research Facility
City
Diepenbeek
Country
Belgium
Facility Name
Research Site
City
Gent
Country
Belgium
Facility Name
Research Site
City
Leuven
Country
Belgium
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Kitchener
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
St-Eustache
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Research Site
City
Quebec
Country
Canada
Facility Name
Research Site
City
Parnu
Country
Estonia
Facility Name
Research Site
City
Tallinn
Country
Estonia
Facility Name
Research Site
City
Tartu
Country
Estonia
Facility Name
Research Site
City
Amiens
Country
France
Facility Name
Research Site
City
Lyon
Country
France
Facility Name
Research Site
City
Orleans
Country
France
Facility Name
Research Site
City
Vandoeuvre
Country
France
Facility Name
Research Site
City
Balatonfured
Country
Hungary
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Eger
Country
Hungary
Facility Name
Research Site
City
Gyor
Country
Hungary
Facility Name
Research Site
City
Koranyi Sandor
Country
Hungary
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21947137
Citation
McClung MR, Miller PD, Brown JP, Zanchetta J, Bolognese MA, Benhamou CL, Balske A, Burgio DE, Sarley J, McCullough LK, Recker RR. Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. Osteoporos Int. 2012 Jan;23(1):267-76. doi: 10.1007/s00198-011-1791-y. Epub 2011 Sep 27.
Results Reference
derived

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

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