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

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

Purpose

This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.

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

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

Resource links provided by NLM:

MedlinePlus related topics: Menopause Osteoporosis Vitamin D

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 Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months [ Time Frame: Baseline,12, 24 and 36 months ] [ Designated as safety issue: No ]
Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.

Secondary Outcome Measures:

Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months [ Time Frame: Baseline,12, 24 and 36 months ] [ Designated as safety issue: No ]
Relative change percent (%) from baseline of MA17904 and BM16550 (NCT00048074) in mean total hip BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.
Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months [ Time Frame: Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550) ] [ Designated as safety issue: No ]
Relative percent (%) change from baseline of MA17904 and BM16550 (NCT00048074) in serum C-telopeptide crosslinks of type I collagen (CTX) at trough at 6, 12, 24 and 36 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=6, 12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.
Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
Relative percent (%) change from MA17904 baseline of post-dose suppression of serum C-telopeptide crosslinks of type I collagen (CTX) at 6 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t= 6 months. The baseline value is used as a reference to calculate the relative change from baseline.

Enrollment:	781
Study Start Date:	October 2004
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: ibandronate [Bonviva/Boniva] 3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).
Active Comparator: 2	Drug: ibandronate [Bonviva/Boniva] 2 mg IV every 2 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75% compliance
Ambulatory

Exclusion Criteria:

Patients who completed the Bonviva study BM16550 (NCT00048074) >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

More Information

Additional Information:

Clinical Study Report Synopsis This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00551174 History of Changes
Other Study ID Numbers:	MA17904
Study First Received:	October 29, 2007
Results First Received:	June 30, 2009
Last Updated:	July 20, 2011
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 February 09, 2012