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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
Assessment method [1] 0 0
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)
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
Assessment method [1] 0 0
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 24. The change in BMD was defined as the relative difference between the last individual measurement available at 24 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)
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
Assessment method [2] 0 0
BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at screening, Month 12 and Month 24. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.
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
Assessment method [3] 0 0
BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24.The change in BMD of the proximal femur (total hip, trochanter, femoral neck) was defined as the relative difference between the last individual measurement available at Month 12 or Month 24and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year/2year - BMD at Baseline) / (BMD at Baseline). BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.
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
Assessment method [4] 0 0
BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24. The absolute change in BMD was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.
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
Assessment method [5] 0 0
Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The change in serum CTX was defined as the relative difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline, using the following formula: Relative change = 100 x (CTX at Month 6/Month 12/Month 24- CTX at Baseline) / (CTX at Baseline). Only participants with data available at particular timepoint were analyzed.
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
Assessment method [6] 0 0
Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The absolute change from Baseline in serum CTX was defined as the difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.
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
Assessment method [7] 0 0
A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
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
Assessment method [8] 0 0
A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
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
Assessment method [9] 0 0
A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
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
Assessment method [10] 0 0
A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
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
Assessment method [11] 0 0
A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
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
Assessment method [12] 0 0
A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
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
Assessment method [13] 0 0
A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
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)
Assessment method [14] 0 0
An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Timepoint [14] 0 0
Approximately 2 years
Secondary outcome [15] 0 0
Number of Participants With Any Marked Abnormality in Laboratory Parameters
Assessment method [15] 0 0
Marked laboratory test value abnormalities (high and low) are those which exceed the marked reference range (i.e., a reference range greater than the standard reference range) and which also represents a clinically relevant change from baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows: low and high Hematocrit (0.36 - 0.60 fraction), low and high hemoglobin (11.0 - 20.0 g/dL), low and high platelets (100 - 700 \* 10\^9/L), low and high white blood cell (WBC) (3.0 - 18.0 \* 10\^9/L), high alanine aminotransferase (ALAT) (0 - 60 U/L), high blood urea nitrogen (BUN) (0 - 14.3 mmol/L) , high creatinine (0 - 154 mmol/L), low albumin (27.0 - 48.0 g/L), low and high chloride (95 - 115 mmol/L), low potassium (3.0 - 6.0 mmol/L), low sodium (130 - 150 mmol/L), high calcium (2.00 - 2.90 mmol/L), low and high phosphate (0.75 - 1.60 mmol/L).
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
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 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