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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00048074




Registration number
NCT00048074
Ethics application status
Date submitted
24/10/2002
Date registered
25/10/2002
Date last updated
3/02/2016

Titles & IDs
Public title
DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
Scientific title
A Randomized, Double-blind Study Comparing the Effect of Different Treatment Regimens of Intravenous Bonviva on Lumbar Bone Mineral Density in Women With Osteoporosis
Secondary ID [1] 0 0
BM16550
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Menopausal Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ibandronate [Bonviva/Boniva]
Treatment: Drugs - ibandronate [Bonviva/Boniva]
Treatment: Drugs - ibandronate [Bonviva/Boniva]

Experimental: 1 - oral placebo daily and IV ibandronate 2 mg q 2 mo

Experimental: 2 - oral ibandronate 2.5 mg daily and IV placebo q 2 mo and q 3 mo

Experimental: 3 - oral placebo daily and IV ibandronate 3 mg q 3 mo


Treatment: Drugs: ibandronate [Bonviva/Boniva]
2mg iv every 2 months

Treatment: Drugs: ibandronate [Bonviva/Boniva]
2.5mg po daily

Treatment: Drugs: ibandronate [Bonviva/Boniva]
3mg iv every 3 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months
Timepoint [1] 0 0
Baseline and Month 12
Secondary outcome [1] 0 0
Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months
Timepoint [1] 0 0
Baseline and Month 24
Secondary outcome [2] 0 0
Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24
Timepoint [2] 0 0
Baseline, Month 12 and Month 24
Secondary outcome [3] 0 0
Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24
Timepoint [3] 0 0
Baseline, Month 12 and Month 24
Secondary outcome [4] 0 0
Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24
Timepoint [4] 0 0
Baseline, Month 12 and Month 24
Secondary outcome [5] 0 0
Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24
Timepoint [5] 0 0
Baseline, At Month 6, 12, and 24.
Secondary outcome [6] 0 0
Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24
Timepoint [6] 0 0
Baseline, At Month 6, 12, and 24.
Secondary outcome [7] 0 0
Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24
Timepoint [7] 0 0
At Month 12 and 24
Secondary outcome [8] 0 0
Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24
Timepoint [8] 0 0
At Month 12 and 24
Secondary outcome [9] 0 0
Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24
Timepoint [9] 0 0
At Month 12 and 24
Secondary outcome [10] 0 0
Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24
Timepoint [10] 0 0
At Month 12 and 24
Secondary outcome [11] 0 0
Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
Timepoint [11] 0 0
At Month 12 and 24
Secondary outcome [12] 0 0
Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
Timepoint [12] 0 0
At Month 12 and 24
Secondary outcome [13] 0 0
Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
Timepoint [13] 0 0
At Month 12 and 24
Secondary outcome [14] 0 0
Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs)
Timepoint [14] 0 0
Approximately 2 years
Secondary outcome [15] 0 0
Number of Participants With Any Marked Abnormality in Laboratory Parameters
Timepoint [15] 0 0
Approximately 2 years

Eligibility
Key inclusion criteria
* women 55-80 years of age;
* post-menopausal for >=5 years;
* ambulatory.
Minimum age
55 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2005
Sample size
Target
Accrual to date
Final
1395
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Melbourne
Recruitment hospital [3] 0 0
- Nedlands
Recruitment hospital [4] 0 0
- St. Leonards
Recruitment hospital [5] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3084 - Melbourne
Recruitment postcode(s) [3] 0 0
6000 - Nedlands
Recruitment postcode(s) [4] 0 0
2139 - St. Leonards
Recruitment postcode(s) [5] 0 0
3129 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
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California
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Florida
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Georgia
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Idaho
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Maryland
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Missouri
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Montana
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United States of America
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Nebraska
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New Mexico
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New York
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North Dakota
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Pennsylvania
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South Dakota
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Texas
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Virginia
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Wisconsin
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Belgium
State/province [18] 0 0
Bruxelles
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Belgium
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Liege
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Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
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Canada
State/province [22] 0 0
Saskatchewan
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Czech Republic
State/province [23] 0 0
Plzen
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Czech Republic
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Praha
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Denmark
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Aalborg
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Denmark
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Ballerup
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Denmark
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København
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Denmark
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Vejle
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Denmark
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Århus
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France
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Lyon
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France
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Orleans
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Hamburg
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Hungary
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Budapest
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Italy
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Arenzano
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Italy
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Siena
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Italy
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Valeggio Sul Mincio
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Mexico
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Mexico City
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Mexico
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Monterrey
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Norway
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Haugesund
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Norway
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Oslo
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Norway
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Stavanger
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Poland
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Grudziadz
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Poland
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Krakow
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South Africa
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Cape Town
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South Africa
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Pretoria
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South Africa
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Sommerset West
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Santander
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United Kingdom
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Aberdeen
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United Kingdom
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Manchester
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United Kingdom
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Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00048074
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00048074