A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
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.
1 other identifier
interventional
923
8 countries
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2007
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 5, 2007
CompletedFirst Posted
Study publicly available on registry
October 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
June 21, 2011
CompletedApril 22, 2013
April 1, 2013
2.5 years
October 5, 2007
April 13, 2011
April 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population
52 weeks / Endpoint
Secondary Outcomes (50)
Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population
Week 52 / Endpoint
Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population
Week 26
Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population
Week 52
Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population
Week 104
Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population
Week 104 / Endpoint
- +45 more secondary outcomes
Study Arms (3)
5 mg Before Breakfast
ACTIVE COMPARATOR5 mg / Immediate-release Risedronate (At Least 30 Minutes Before Breakfast)
35 mg After Breakfast
EXPERIMENTAL35 mg / Delayed-release Risedronate (Immediately Following Breakfast)
35 mg Before Breakfast
EXPERIMENTAL35 mg / Delayed-release Risedronate (At Least 30 Minutes Before Breakfast)
Interventions
5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Warner Chilcottlead
Study Sites (45)
Research Site
Birmingham, Alabama, United States
Research Site
Oakland, California, United States
Research Site
San Diego, California, United States
Research Facility
Walnut Creek, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Lakewood, Colorado, United States
Research Site
Leesburg, Florida, United States
Research Site
Melbourne, Florida, United States
Research Site
South Miami, Florida, United States
Research Site
Gainesville, Georgia, United States
Research Site
Champaign, Illinois, United States
Research Site
Chicago, Illinois, United States
Research Site
Bethesda, Maryland, United States
Research Site
Brockton, Massachusetts, United States
Research Site
Omaha, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Greenville, North Carolina, United States
Research Site
Portland, Oregon, United States
Research Site
Seattle, Washington, United States
Research Site
Madison, Wisconsin, United States
Research Site
Buenos Aires, Argentina
Research Facility
Diepenbeek, Belgium
Research Site
Ghent, Belgium
Research Site
Leuven, Belgium
Research Site
Hamilton, Ontario, Canada
Research Site
Kitchener, Ontario, Canada
Research Site
Newmarket, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Saint-Eustache, Quebec, Canada
Research Site
Saskatoon, Saskatchewan, Canada
Research Site
Pärnu, Estonia
Research Site
Tallinn, Estonia
Research Site
Tartu, Estonia
Research Site
Amiens, France
Research Site
Lyon, France
Research Site
Orléans, France
Research Site
Vandœuvre-lès-Nancy, France
Research Site
Balatonfüred, Hungary
Research Site
Debrecen, Hungary
Research Site
Eger, Hungary
Research Site
Győr, Hungary
Research Site
Koranyi Sandor, Hungary
Research Site
Bialystok, Poland
Research Site
Warsaw, Poland
Related Publications (1)
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.
PMID: 21947137DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Grexan Wulff, Manager Regulatory Affairs
- Organization
- Warner Chilcott
Study Officials
- STUDY DIRECTOR
Ana Balske, MD, PhD
Procter and Gamble
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2007
First Posted
October 10, 2007
Study Start
October 1, 2007
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
April 22, 2013
Results First Posted
June 21, 2011
Record last verified: 2013-04