DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Post-Menopausal Osteoporosis	Drug: ibandronate [Bonviva/Boniva]	Phase III

MedlinePlus related topics:

Menopause Minerals Osteoporosis

ChemIDplus related topics:

Ibandronate sodium Ibandronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Relative change (%) from baseline in mean lumbar spine bone mineral density (BMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relative change in mean lumbar spine BMD [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Relative and absolute change in total hip, trochanter, femoral neck BMD [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Percentage of responders [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Change from baseline in fastin serum CTX [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	1395
Study Completion Date:	December 2005

Arms	Assigned Interventions
1: Experimental	Drug: ibandronate [Bonviva/Boniva] 2mg iv every 2 months
2: Experimental	Drug: ibandronate [Bonviva/Boniva] 2.5mg po daily
3: Experimental	Drug: ibandronate [Bonviva/Boniva] 3mg iv every 3 months
4: Active Comparator	Drug: ibandronate [Bonviva/Boniva] 2.5mg po daily

Eligibility

Ages Eligible for Study:	55 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048074

Show 58 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BM16550
First Received:	October 24, 2002
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00048074
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Ibandronic acid

Musculoskeletal Diseases

Osteoporosis, Postmenopausal

Osteoporosis

Bone Diseases, Metabolic

Bone Diseases

Menopause

Additional relevant MeSH terms:

Physiological Effects of Drugs

Bone Density Conservation Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00048074