A Study of Monthly Risedronate for Osteoporosis
A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)
2 other identifiers
interventional
1,294
13 countries
46
Brief Summary
The purpose of this trial is to study the efficacy of a single-dose monthly 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 2005
46 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, 2005
CompletedFirst Submitted
Initial submission to the registry
October 28, 2005
CompletedFirst Posted
Study publicly available on registry
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
June 21, 2011
CompletedApril 22, 2013
April 1, 2013
2.4 years
October 28, 2005
March 4, 2011
April 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).
Baseline to Month 12 - Endpoint
Secondary Outcomes (19)
Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
Baseline to Month 12
Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
Baseline to Month 12
Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)
Baseline to Month 24 - Endpoint
Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
Baseline to Month 24
Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
Baseline to Month 24
- +14 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATOR5 mg risedronate, once daily for 2 years
2
EXPERIMENTAL150 mg risedronate taken once a month for 2 years
Interventions
Eligibility Criteria
You may qualify if:
- Female: 50 years of age or older
- \>5 years since last menses natural or surgical
- have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine 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 (body mass index) \>32 kg/m\^2
- 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
- Sanoficollaborator
Study Sites (49)
Research Site
Lakewood, Colorado, 80227, United States
Research Site
Gainesville, Georgia, 30501, United States
Research Site
Bethesda, Maryland, 20817, United States
Research Site
Omaha, Nebraska, 068131, United States
Research Site
West Haverstraw, New York, 10983, United States
Research Site
Cincinnati, Ohio, 45219, United States
Research Site
Portland, Oregon, 97212, United States
Research Site
Buenos Aires, Buenos Aires, Argentina
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Capital Federal, Argentina
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Geelong, Australia
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Heidelberg, Victoria, Australia
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Saint Leonards, Australia
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Brussels, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Mont Godinne, Belgium
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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Calgary, Canada
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Montreal, Canada
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Sainte-Foy, Canada
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Saskatoon, Canada
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Pärnu, Estonia
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Tartu, Estonia
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Helsinki, Finland
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Kuopio, Finland
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Oulu, Finland
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Turku, Finland
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Amiens, France
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Lyon, France
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Orléans, France
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Paris, France
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Toulouse, France
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Vandœuvre-lès-Nancy, France
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Balatonfüred, Hungary
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Budapest, Hungary
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Győr, Hungary
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Miskolc, Hungary
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Nagykanizs, Hungary
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Beirut, Lebanon
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Oslo, Norway
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Paradis, Norway
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Trondheim, Norway
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Bialystok, Poland
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Warsaw, Poland
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Barcelona, Spain
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Granada, Spain
Research Site
Madrid, Spain
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
Sal Bartelmo, MD
P&G
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2005
First Posted
November 1, 2005
Study Start
October 1, 2005
Primary Completion
March 1, 2008
Study Completion
April 1, 2008
Last Updated
April 22, 2013
Results First Posted
June 21, 2011
Record last verified: 2013-04