Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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