- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02598934
A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis
February 10, 2016 updated by: Hoffmann-La Roche
A Prospective Open-Label, Multicenter Study to Evaluate the Change in Bone Turnover Markers After Once Monthly Oral Ibandronate Therapy in Treatment Naive Postmenopausal Osteoporosis Patients
This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment.
The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.
Study Overview
Study Type
Interventional
Enrollment (Actual)
308
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ponce, Puerto Rico, 00717-1318
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San Juan, Puerto Rico, 00935
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San Juan, Puerto Rico, 00927
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Alabama
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Montgomery, Alabama, United States, 36111
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Arizona
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Chandler, Arizona, United States, 85225
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Peoria, Arizona, United States, 85381
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Arkansas
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Hot Springs, Arkansas, United States, 71913
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Pine Bluff, Arkansas, United States, 71603
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California
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Anaheim, California, United States, 92801
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Beverly Hills, California, United States, 90211
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Carmichael, California, United States, 95608
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Delaware
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Wilmington, Delaware, United States, 19805
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Florida
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Deland, Florida, United States, 32720
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Miami, Florida, United States, 33186
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Miami, Florida, United States, 33176
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Palm Habor, Florida, United States, 34684
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Palm Springs, Florida, United States, 33461
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West Palm Beach, Florida, United States, 33409
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Georgia
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Atlanta, Georgia, United States, 30309
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Rome, Georgia, United States, 30165
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Illinois
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Morton Grove, Illinois, United States, 60053
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Indiana
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Indianapolis, Indiana, United States, 46202
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Iowa
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Waterloo, Iowa, United States, 50702
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Maryland
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Baltimore, Maryland, United States, 21209
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Hagerstown, Maryland, United States, 21740
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Reistertown, Maryland, United States, 21136
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Mississippi
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Olive Branch, Mississippi, United States, 38654
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Missouri
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Jefferson City, Missouri, United States, 65109
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St Louis, Missouri, United States, 63108
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Nebraska
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Omaha, Nebraska, United States, 68131
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New Jersey
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Bloomfield, New Jersey, United States, 07003
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New York
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Bronx, New York, United States, 10461
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New York, New York, United States, 10016
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North Carolina
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Morehead City, North Carolina, United States, 28557
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Morganton, North Carolina, United States, 28655
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Raleigh, North Carolina, United States, 27612
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
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Oregon
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Medford, Oregon, United States, 97504
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Pennsylvania
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Doylestown, Pennsylvania, United States, 18901
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Langhorne, Pennsylvania, United States, 19047
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Philadelphia, Pennsylvania, United States, 19131
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South Carolina
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Mount Pleasant, South Carolina, United States, 29464
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Spartanburg, South Carolina, United States, 29307
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Tennessee
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Morristown, Tennessee, United States, 37813
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Murfreesboro, Tennessee, United States, 37130
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Nashville, Tennessee, United States, 37203
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Texas
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Amarillo, Texas, United States, 79106
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Fort Worth, Texas, United States, 76101
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San Antonio, Texas, United States, 78229
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Texarkana, Texas, United States, 75503
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Virginia
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Richmond, Virginia, United States, 23226
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Washington
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Tacoma, Washington, United States, 98405
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Wisconsin
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Madison, Wisconsin, United States, 53705
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women newly diagnosed with postmenopausal osteoporosis
- Naive to prior bisphosphonate therapy
Exclusion Criteria:
- Inability to stand or sit upright for at least 60 minutes
- Inability to swallow a tablet whole
- Hypersensitivity to any component of ibandronate
- Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months
- Other osteoporosis drug within last 3 months
- Malignant disease diagnosed within previous 10 years, except resected basal cell cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Ibandronate Group 1
Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly.
Group 1 will receive a physician consultation after 4 months of treatment to review bone turnover test results.
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Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
Other Names:
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Experimental: Ibandronate Group 2
Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly.
Group 2 will not receive a physician consultation.
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Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)
Time Frame: Baseline, Month 6
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Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL).
Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100.
Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
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Baseline, Month 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)
Time Frame: Baseline, Month 6
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Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine.
Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100.
Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
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Baseline, Month 6
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Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
Time Frame: Baseline, Month 6
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Serum P1NP is a measure of bone resorption and is measured as ng/mL.
Percent change from baseline to Month 6 was calculated using Month 6 value minus Baseline value divided by baseline value, and then multiplied by 100.
Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
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Baseline, Month 6
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Percent Change From Baseline to Month 6 in Serum Osteocalcin
Time Frame: Baseline, Month 6
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Serum osteocalcin is a measure of bone resorption and is measured as ng/mL.
Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100.
Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
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Baseline, Month 6
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Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)
Time Frame: Baseline, Month 6
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Serum BSAP is a measure of bone resorption and is measured as ng/mL.
Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100.
Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
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Baseline, Month 6
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Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6
Time Frame: Month 6
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The BCS is designed to measure the participant's confidence level that Boniva (ibandronate) therapy is effective in treating osteoporosis and reducing the risk of fracture.
Response options ranged on a 5-point scale from 'Not At All Confident' to 'Very Confident.'
A Boniva confidence responder was defined as a participant who reported a response of 'confident' or 'very confident' on the 2 items in BCS.
(1) ibandronate was effective in treating osteoporosis and (2) ibandronate reduces the risk of breaking a bone.
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Month 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Primary Completion (Actual)
May 1, 2006
Study Completion (Actual)
May 1, 2006
Study Registration Dates
First Submitted
November 4, 2015
First Submitted That Met QC Criteria
November 4, 2015
First Posted (Estimate)
November 6, 2015
Study Record Updates
Last Update Posted (Estimate)
March 9, 2016
Last Update Submitted That Met QC Criteria
February 10, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML18057
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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