Clinical trial NCT00551174: A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-Menopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-10-30
Enrollment: 781
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75% compliance
* Ambulatory

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

Primary outcomes:
measure: Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months
timeFrame: Baseline,12, 24 and 36 months
Secondary outcomes:
measure: Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months
timeFrame: Baseline,12, 24 and 36 months
measure: Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months
timeFrame: Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550)
measure: Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Gainesville
country: United States
state: Georgia
city: St Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Bismarck
country: United States
state: North Dakota
city: Fargo
country: United States
state: North Dakota
city: Madison
country: United States
state: Wisconsin
city: St. Leonards
country: Australia
city: Sydney
country: Australia
city: Bruxelles
country: Belgium
city: Liege
country: Belgium
city: Plzen
country: Czech Republic
city: Praha
country: Czech Republic
city: Aalborg
country: Denmark
city: Ballerup
country: Denmark
city: København
country: Denmark
city: Vejle
country: Denmark
city: Århus
country: Denmark
city: Lyon
country: France
city: Orleans
country: France
city: Berlin
country: Germany
city: Essen
country: Germany
city: Hamburg
country: Germany
city: Budapest
country: Hungary
city: Arenzano
country: Italy
city: Siena
country: Italy
city: Valeggio Sul Mincio
country: Italy
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Haugesund
country: Norway
city: Oslo
country: Norway
city: Stavanger
country: Norway
city: Grudziadz
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Cape Town
country: South Africa
city: Pretoria
country: South Africa
city: Sommerset West
country: South Africa
city: Madrid
country: Spain
city: Aberdeen
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: