A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00081653

Purpose

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.

Condition	Intervention	Phase
Post-Menopausal Osteoporosis	Drug: ibandronate [Bonviva/Boniva]	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Menopause Osteoporosis

Drug Information available for: Ibandronic acid Ibandronate sodium

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Relative (%) Change From MA17903 Baseline in Mean Lumbar Spine (L2 - L4) BMD [ Time Frame: Assessed at Baseline +12, 24, and 36 months ] [ Designated as safety issue: No ]
Absolute (g/cm2) Change From MA17903 Baseline in Mean Lumbar Spine (L2 - L4) BMD [ Time Frame: Assessed at baseline +12, 24 and 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relative (%) and Absolute (g/cm2) Change From MA17903 Baseline in Mean Total Hip BMD [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
Relative (%) and Absolute (ng/mL) Change From MA17903 Baseline of Median Trough Serum CTX [Type I Collagen] [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
Relative (%) and Absolute (ng/mL) Change From MA17903 Baseline of Median Post Dose Suppression of Serum CTX [Type I Collagen] [ Time Frame: 6 months of treatment ] [ Designated as safety issue: No ]

Enrollment:	719
Study Completion Date:	May 2008

Arms	Assigned Interventions
Experimental: 1	Drug: ibandronate [Bonviva/Boniva] 150mg po monthly for 3 years
Active Comparator: 2	Drug: ibandronate [Bonviva/Boniva] 100mg po monthly for 3 years

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081653

Show 31 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00081653 History of Changes
Other Study ID Numbers:	MA17903
Study First Received:	April 19, 2004
Results First Received:	December 22, 2008
Last Updated:	June 2, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

Ibandronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2012