DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
A Randomized, Double-blind Study Comparing the Effect of Different Treatment Regimens of Intravenous Bonviva on Lumbar Bone Mineral Density in Women With Osteoporosis
1 other identifier
interventional
1,395
16 countries
64
Brief Summary
This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2002
Typical duration for phase_3
64 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
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 24, 2002
CompletedFirst Posted
Study publicly available on registry
October 25, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedResults Posted
Study results publicly available
February 3, 2016
CompletedFebruary 3, 2016
January 1, 2016
2.9 years
October 24, 2002
January 4, 2016
January 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months
BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 12. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)
Baseline and Month 12
Secondary Outcomes (15)
Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months
Baseline and Month 24
Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24
Baseline, Month 12 and Month 24
Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24
Baseline, Month 12 and Month 24
Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24
Baseline, Month 12 and Month 24
Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24
Baseline, At Month 6, 12, and 24.
- +10 more secondary outcomes
Study Arms (3)
1
EXPERIMENTALoral placebo daily and IV ibandronate 2 mg q 2 mo
2
EXPERIMENTALoral ibandronate 2.5 mg daily and IV placebo q 2 mo and q 3 mo
3
EXPERIMENTALoral placebo daily and IV ibandronate 3 mg q 3 mo
Interventions
Eligibility Criteria
You may qualify if:
- women 55-80 years of age;
- post-menopausal for \>=5 years;
- ambulatory.
You may not qualify if:
- malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
- breast cancer within the previous 20 years;
- allergy to bisphosphonates;
- previous treatment with an intravenous bisphosphonate at any time;
- previous treatment with an oral bisphosphonate within the last 6 months, \>1 month of treatment within the last year, or \>3 months of treatment within the last 2 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
Unknown Facility
Little Rock, Arkansas, 72205-7199, United States
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Irvine, California, 92618, United States
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Rancho Mirage, California, 92270, United States
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Leesburg, Florida, 34748, United States
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Gainesville, Georgia, 30501, United States
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Coeur d'Alene, Idaho, 83814, United States
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Bethesda, Maryland, 20817, United States
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St Louis, Missouri, 63110, United States
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Billings, Montana, 59120, United States
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Omaha, Nebraska, 68131, United States
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Albuquerque, New Mexico, 87106, United States
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New York, New York, 10029, United States
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Bismarck, North Dakota, 58503, United States
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Fargo, North Dakota, 58103, United States
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Wyomissing, Pennsylvania, 19610, United States
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Rapid City, South Dakota, 57701, United States
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San Antonio, Texas, 78229, United States
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Virginia Beach, Virginia, 23462, United States
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Madison, Wisconsin, 53792, United States
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Darlinghurst, 2010, Australia
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Melbourne, 3084, Australia
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Nedlands, 6000, Australia
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St Leonards, 2139, Australia
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Sydney, 3129, Australia
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Brussels, 1180, Belgium
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Liège, 4020, Belgium
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Toronto, Ontario, M5C 2T2, Canada
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Laval, Quebec, H7T 2P5, Canada
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Montreal, Quebec, H2X 3J4, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Saskatoon, Saskatchewan, S7K 0H6, Canada
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Pilsen, 305 99, Czechia
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Prague, 128 00, Czechia
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Aalborg, 9000, Denmark
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Aarhus, 8000, Denmark
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Ballerup Municipality, 2750, Denmark
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Copenhagen, 1399, Denmark
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Vejle, 7100, Denmark
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Lyon, 69437, France
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Orléans, 45000, France
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Berlin, 12200, Germany
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Bochum, 44789, Germany
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Hamburg, 20246, Germany
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Budapest, 1036, Hungary
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Arenzano, 16011, Italy
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Siena, 53100, Italy
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Valeggio sul Mincio, 37067, Italy
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Mexico City, 11000, Mexico
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Monterrey, 64460, Mexico
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Haugesund, 5507, Norway
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Oslo, 0176, Norway
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Stavanger, 4010, Norway
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Grudziądz, 86-300, Poland
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Krakow, 30-510, Poland
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Krakow, 31-501, Poland
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Cape Town, 7500, South Africa
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Pretoria, South Africa
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Sommerset West, 7129, South Africa
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Barcelona, 08003, Spain
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Madrid, 28046, Spain
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Santander, 39008, Spain
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Aberdeen, AB25 1LD, United Kingdom
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Manchester, M13 9WL, United Kingdom
Unknown Facility
Newcastle upon Tyne, NE7 7DN, United Kingdom
Related Publications (1)
Bianchi G, Czerwinski E, Kenwright A, Burdeska A, Recker RR, Felsenberg D. Long-term administration of quarterly IV ibandronate is effective and well tolerated in postmenopausal osteoporosis: 5-year data from the DIVA study long-term extension. Osteoporos Int. 2012 Jun;23(6):1769-78. doi: 10.1007/s00198-011-1793-9.
PMID: 21975558DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2002
First Posted
October 25, 2002
Study Start
June 1, 2002
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
February 3, 2016
Results First Posted
February 3, 2016
Record last verified: 2016-01