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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00551174




Registration number
NCT00551174
Ethics application status
Date submitted
29/10/2007
Date registered
30/10/2007
Date last updated
22/07/2011

Titles & IDs
Public title
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment
Scientific title
Open Label, Parallel Group, Multicenter Study of Two Intravenous (IV) Ibandronate Dose Regimens (2 mg Every 2 Months and 3 mg Every 3 Months) in Women With Postmenopausal Osteoporosis Who Completed Trial BM16550
Secondary ID [1] 0 0
MA17904
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]

Experimental: 1 -

Active Comparator: 2 -


Treatment: Drugs: ibandronate [Bonviva/Boniva]
3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).

Treatment: Drugs: ibandronate [Bonviva/Boniva]
2 mg IV every 2 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).
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 Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months
Timepoint [1] 0 0
Baseline,12, 24 and 36 months
Secondary outcome [1] 0 0
Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months
Timepoint [1] 0 0
Baseline,12, 24 and 36 months
Secondary outcome [2] 0 0
Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months
Timepoint [2] 0 0
Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550)
Secondary outcome [3] 0 0
Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months
Timepoint [3] 0 0
Baseline, 6 months

Eligibility
Key inclusion criteria
- Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75%
compliance

- Ambulatory
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who completed the Bonviva study BM16550 (NCT00048074) >3 months before the
planned start date for this study

- Malignant disease diagnosed since inclusion into previous study

- Treatment with drugs affecting bone metabolism since inclusion into previous study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
Accrual to date
Final
781
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- St. Leonards
Recruitment hospital [2] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
2139 - St. Leonards
Recruitment postcode(s) [2] 0 0
3129 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
Nebraska
Country [4] 0 0
United States of America
State/province [4] 0 0
North Dakota
Country [5] 0 0
United States of America
State/province [5] 0 0
Wisconsin
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Belgium
State/province [7] 0 0
Liege
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Plzen
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Praha
Country [10] 0 0
Denmark
State/province [10] 0 0
Aalborg
Country [11] 0 0
Denmark
State/province [11] 0 0
Ballerup
Country [12] 0 0
Denmark
State/province [12] 0 0
København
Country [13] 0 0
Denmark
State/province [13] 0 0
Vejle
Country [14] 0 0
Denmark
State/province [14] 0 0
Århus
Country [15] 0 0
France
State/province [15] 0 0
Lyon
Country [16] 0 0
France
State/province [16] 0 0
Orleans
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Essen
Country [19] 0 0
Germany
State/province [19] 0 0
Hamburg
Country [20] 0 0
Hungary
State/province [20] 0 0
Budapest
Country [21] 0 0
Italy
State/province [21] 0 0
Arenzano
Country [22] 0 0
Italy
State/province [22] 0 0
Siena
Country [23] 0 0
Italy
State/province [23] 0 0
Valeggio Sul Mincio
Country [24] 0 0
Mexico
State/province [24] 0 0
Mexico City
Country [25] 0 0
Mexico
State/province [25] 0 0
Monterrey
Country [26] 0 0
Norway
State/province [26] 0 0
Haugesund
Country [27] 0 0
Norway
State/province [27] 0 0
Oslo
Country [28] 0 0
Norway
State/province [28] 0 0
Stavanger
Country [29] 0 0
Poland
State/province [29] 0 0
Grudziadz
Country [30] 0 0
Poland
State/province [30] 0 0
Krakow
Country [31] 0 0
South Africa
State/province [31] 0 0
Cape Town
Country [32] 0 0
South Africa
State/province [32] 0 0
Pretoria
Country [33] 0 0
South Africa
State/province [33] 0 0
Sommerset West
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Aberdeen

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

Ethics approval
Ethics application status

Summary
Brief summary
This 2-arm study was designed to assess the long-term safety and tolerability of intravenous
(IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had
previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received
Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received
daily supplementation with vitamin D and calcium. The anticipated time on study treatment was
2+ years, and the target sample size was 500+ individuals.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00551174
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00551174