Clinical trial NCT00081653: A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva
Official title: Double-blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-Menopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2004-04-21
Enrollment: 719
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.


Eligibility criteria: Inclusion Criteria:

* successful completion of Bonviva study BM16549, with at least 75% compliance;
* ambulatory.

Exclusion Criteria:

* malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);
* breast cancer diagnosed within the previous 22 years.

Primary outcomes:
measure: Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD
timeFrame: Baseline and Months 12, 24 and 36
measure: Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)
timeFrame: Baseline and Months 12, 24 and 36
Secondary outcomes:
measure: Absolute Change From Baseline in Mean Total Hip BMD
timeFrame: Baseline and 12, 24 and 36 months
measure: Relative Percent Change From Baseline in Mean Total Hip BMD
timeFrame: Baseline, 12, 24 and 36 months
measure: Absolute Change From Baseline of Trough Serum CTX
timeFrame: Baseline, 6, 12, 24 and 36 months
measure: Relative Percent Change From Baseline of Trough Serum CTX
timeFrame: Baseline, 6,12, 24 and 36 months
Other outcomes:
Locations:
city: Loma Linda
country: United States
state: California
city: Lakewood
country: United States
state: Colorado
city: Omaha
country: United States
state: Nebraska
city: Livingston
country: United States
state: New Jersey
city: Portland
country: United States
state: Oregon
city: Liege
country: Belgium
city: Merksem
country: Belgium
city: Sao Paulo
country: Brazil
city: Plzen
country: Czechia
city: Praha
country: Czechia
city: Aalborg
country: Denmark
city: Ballerup
country: Denmark
city: Vejle
country: Denmark
city: Lyon
country: France
city: Berlin
country: Germany
city: Hannover
country: Germany
city: Balatonfuered
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Kiskunhalas
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Siena
country: Italy
city: Leon
country: Mexico
city: Obregon
country: Mexico
city: Haugesund
country: Norway
city: Stavanger
country: Norway
city: Krakow
country: Poland
city: Warszawa
country: Poland
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Southampton
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: