A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00551174

Purpose

This 2 arm study will assess the long-term safety and tolerability of intravenous treatment with 2mg or 3mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16550 (DIVA study). Patients will receive Bonviva either 2mg iv every 2 months, or 3mg iv every 3 months 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 IV

MedlinePlus related topics: Menopause Osteoporosis

Drug Information available for: Ibandronate sodium Ibandronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Open Label, Parallel Group, Multicenter Study of Two IV Ibandronate Dose Regimens (2 mg Every 2 Months and 3 mg Every 3 Months) in Women With Postmenopausal Osteoporosis Who Completed Trial BM16550

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Relative change in mean lumbar spine bone mineral density (BMD) [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relative change in mean total hip BMD [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
Relative change in serum CTX [ Time Frame: Trough and peak suppression ] [ Designated as safety issue: No ]
AEs and laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	781
Study Completion Date:	May 2005

Arms	Assigned Interventions
1: Experimental	Drug: ibandronate [Bonviva/Boniva] 3mg iv / 3 months for 3 years
2: Active Comparator	Drug: ibandronate [Bonviva/Boniva] 2mg iv / 2 months for 3 years

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

successful completion of Bonviva study BM16550, with at least 75% compliance;
ambulatory.

Exclusion Criteria:

patients who completed the Bonviva study BM16550 >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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551174

Show 39 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:	MA17904
Study First Received:	October 29, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00551174
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 January 15, 2009