Clinical trial NCT00048061: MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
Official title: Randomized, Double-blind, Double Dummy, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of Monthly Oral Administration of 100 mg and 150 mg Ibandronate With 2.5 mg Daily Oral Ibandronate in Postmenopausal Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Menopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2002-10-25
Enrollment: 1609
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. 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:

* women 55-80 years of age;
* post-menopausal for \>= 5 years;
* ambulatory.

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.

Primary outcomes:
measure: Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density
timeFrame: From Baseline (Month 0) to Month 12
Secondary outcomes:
measure: Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
timeFrame: From Baseline (Month 0) to Month 24
measure: Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
timeFrame: From Baseline (Month 0) to Months 12 and 24
measure: Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
timeFrame: From Baseline (Month 0) to Months 12 and 24
measure: Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
timeFrame: From Baseline (Month 0) to Months 12 and 24
measure: Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24
timeFrame: Months 12 and 24
measure: Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24
timeFrame: Months 12 and 24
measure: Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24
timeFrame: Months 12 and 24
measure: Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24
timeFrame: Months 12 and 24
measure: Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
timeFrame: Months 12 and 24
measure: Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
timeFrame: Months 12 and 24
measure: Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
timeFrame: Months 12 and 24
measure: Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24
timeFrame: From Baseline (Month 0) to Months 3, 6, 12, 24
measure: Absolute Change In Baseline in Serum CTX to Months 12 and 24
timeFrame: From Baseline (Month 0) to Months 12 and 24
measure: Number of Participants With Any Adverse Events and Serious Adverse Event
timeFrame: Up to Month 24
measure: Number Of Participants With Marked Laboratory Abnormalities
timeFrame: Up to Month 24
Other outcomes:
Locations:
city: Irvine
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Oakland
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Lakewood
country: United States
state: Colorado
city: Gainesville
country: United States
state: Florida
city: Bethesda
country: United States
state: Maryland
city: Wheaton
country: United States
state: Maryland
city: Saint Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Livingston
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Portland
country: United States
state: Oregon
city: Wyomissing
country: United States
state: Pennsylvania
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Adelaide
country: Australia
city: Adelaide
country: Australia
city: Parkville
country: Australia
city: Perth
country: Australia
city: Liege
country: Belgium
city: Merksem
country: Belgium
city: Campinas
country: Brazil
city: Curitiba
country: Brazil
city: Porto Alegre
country: Brazil
city: Sao Paulo
country: Brazil
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Toronto
country: Canada
state: Ontario
city: Quebec City
country: Canada
state: Quebec
city: Plzen
country: Czechia
city: Praha
country: Czechia
city: Praha
country: Czechia
city: Aalborg
country: Denmark
city: Ballerup
country: Denmark
city: Vejle
country: Denmark
city: Caen
country: France
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: Valeggio Sul Mincio
country: Italy
city: Leon
country: Mexico
city: Obregon
country: Mexico
city: Haugesund
country: Norway
city: Oslo
country: Norway
city: Stavanger
country: Norway
city: Krakow
country: Poland
city: Warszawa
country: Poland
city: Bucharest
country: Romania
city: Cape Town
country: South Africa
city: Johannesburg
country: South Africa
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Zürich
country: Switzerland
city: Cardiff
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Southampton
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: