Clinical trial NCT00048074: DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
Official title: A Randomized, Double-blind Study Comparing the Effect of Different Treatment Regimens of Intravenous Bonviva on Lumbar Bone Mineral Density in Women With 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: 1395
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 assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. 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 Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months
timeFrame: Baseline and Month 24
measure: Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24
timeFrame: Baseline, Month 12 and Month 24
measure: Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24
timeFrame: Baseline, Month 12 and Month 24
measure: Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24
timeFrame: Baseline, Month 12 and Month 24
measure: Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24
timeFrame: Baseline, At Month 6, 12, and 24.
measure: Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24
timeFrame: Baseline, At Month 6, 12, and 24.
measure: Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24
timeFrame: At Month 12 and 24
measure: Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24
timeFrame: At Month 12 and 24
measure: Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24
timeFrame: At Month 12 and 24
measure: Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24
timeFrame: At Month 12 and 24
measure: Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
timeFrame: At Month 12 and 24
measure: Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
timeFrame: At Month 12 and 24
measure: Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
timeFrame: At Month 12 and 24
measure: Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Approximately 2 years
measure: Number of Participants With Any Marked Abnormality in Laboratory Parameters
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Irvine
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Leesburg
country: United States
state: Florida
city: Gainesville
country: United States
state: Georgia
city: Coeur D'alene
country: United States
state: Idaho
city: Bethesda
country: United States
state: Maryland
city: St Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Bismarck
country: United States
state: North Dakota
city: Fargo
country: United States
state: North Dakota
city: Wyomissing
country: United States
state: Pennsylvania
city: Rapid City
country: United States
state: South Dakota
city: San Antonio
country: United States
state: Texas
city: Virginia Beach
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
city: Darlinghurst
country: Australia
city: Melbourne
country: Australia
city: Nedlands
country: Australia
city: St. Leonards
country: Australia
city: Sydney
country: Australia
city: Bruxelles
country: Belgium
city: Liege
country: Belgium
city: Toronto
country: Canada
state: Ontario
city: Laval
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
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: Bochum
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: Barcelona
country: Spain
city: Madrid
country: Spain
city: Santander
country: Spain
city: Aberdeen
country: United Kingdom
city: Manchester
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Bianchi G, Czerwinski E, Kenwright A, Burdeska A, Recker RR, Felsenberg D. Long-term administration of quarterly IV ibandronate is effective and well tolerated in postmenopausal osteoporosis: 5-year data from the DIVA study long-term extension. Osteoporos Int. 2012 Jun;23(6):1769-78. doi: 10.1007/s00198-011-1793-9.