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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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Montana
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Dakota
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Dakota
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Belgium
State/province [18] 0 0
Bruxelles
Country [19] 0 0
Belgium
State/province [19] 0 0
Liege
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Canada
State/province [22] 0 0
Saskatchewan
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Plzen
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Praha
Country [25] 0 0
Denmark
State/province [25] 0 0
Aalborg
Country [26] 0 0
Denmark
State/province [26] 0 0
Ballerup
Country [27] 0 0
Denmark
State/province [27] 0 0
København
Country [28] 0 0
Denmark
State/province [28] 0 0
Vejle
Country [29] 0 0
Denmark
State/province [29] 0 0
Århus
Country [30] 0 0
France
State/province [30] 0 0
Lyon
Country [31] 0 0
France
State/province [31] 0 0
Orleans
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Germany
State/province [33] 0 0
Bochum
Country [34] 0 0
Germany
State/province [34] 0 0
Hamburg
Country [35] 0 0
Hungary
State/province [35] 0 0
Budapest
Country [36] 0 0
Italy
State/province [36] 0 0
Arenzano
Country [37] 0 0
Italy
State/province [37] 0 0
Siena
Country [38] 0 0
Italy
State/province [38] 0 0
Valeggio Sul Mincio
Country [39] 0 0
Mexico
State/province [39] 0 0
Mexico City
Country [40] 0 0
Mexico
State/province [40] 0 0
Monterrey
Country [41] 0 0
Norway
State/province [41] 0 0
Haugesund
Country [42] 0 0
Norway
State/province [42] 0 0
Oslo
Country [43] 0 0
Norway
State/province [43] 0 0
Stavanger
Country [44] 0 0
Poland
State/province [44] 0 0
Grudziadz
Country [45] 0 0
Poland
State/province [45] 0 0
Krakow
Country [46] 0 0
South Africa
State/province [46] 0 0
Cape Town
Country [47] 0 0
South Africa
State/province [47] 0 0
Pretoria
Country [48] 0 0
South Africa
State/province [48] 0 0
Sommerset West
Country [49] 0 0
Spain
State/province [49] 0 0
Barcelona
Country [50] 0 0
Spain
State/province [50] 0 0
Madrid
Country [51] 0 0
Spain
State/province [51] 0 0
Santander
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Aberdeen
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Manchester
Country [54] 0 0
United Kingdom
State/province [54] 0 0
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00048074