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

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

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.

Study Overview

• Status: Completed
• Conditions: Post-Menopausal Osteoporosis
• Intervention / Treatment: Drug: ibandronate [Bonviva/Boniva]; Drug: ibandronate [Bonviva/Boniva]

• Study Type: Interventional
• Enrollment (Actual): 719
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium, 4020
  • Merksem, Belgium, 2170
• Brazil
  • Sao Paulo, Brazil, 04026-000
• Czechia
  • Plzen, Czechia, 305 99
  • Praha, Czechia, 128 00
• Denmark
  • Aalborg, Denmark, 9000
  • Ballerup, Denmark, 2750
  • Vejle, Denmark, 7100
• France
  • Lyon, France, 69000
• Germany
  • Berlin, Germany, 12200
  • Hannover, Germany, 30167
• Hungary
  • Balatonfuered, Hungary, 8230
  • Budapest, Hungary, 1083
  • Budapest, Hungary, 1036
  • Kiskunhalas, Hungary, 6400
  • Zalaegerszeg, Hungary, 8900
• Italy
  • Siena, Italy, 53100
• Mexico
  • Leon, Mexico, 37000
  • Obregon, Mexico, 85100
• Norway
  • Haugesund, Norway, 5507
  • Stavanger, Norway, 4010
• Poland
  • Krakow, Poland, 31-501
  • Warszawa, Poland, 04-730
• Spain
  • Barcelona, Spain, 08907
  • Madrid, Spain, 28041
• United Kingdom
  • Southampton, United Kingdom, SO16 6YD
• United States
  • California
    • Loma Linda, California, United States, 92357
  • Colorado
    • Lakewood, Colorado, United States, 80260
  • Nebraska
    • Omaha, Nebraska, United States, 68131
  • New Jersey
    • Livingston, New Jersey, United States, 07039
  • Oregon
    • Portland, Oregon, United States, 97213

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: ibandronate [Bonviva/Boniva]; 150mg po monthly for 3 years; Drug: ibandronate [Bonviva/Boniva]; 100mg po monthly for 3 years
Active Comparator: 2	Drug: ibandronate [Bonviva/Boniva]; 150mg po monthly for 3 years; Drug: ibandronate [Bonviva/Boniva]; 100mg po monthly for 3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD	Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).	Baseline and Months 12, 24 and 36
Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)	BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae [L2-L4] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).	Baseline and Months 12, 24 and 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change From Baseline in Mean Total Hip BMD	BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).	Baseline and 12, 24 and 36 months
Relative Percent Change From Baseline in Mean Total Hip BMD	BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).	Baseline, 12, 24 and 36 months
Absolute Change From Baseline of Trough Serum CTX	CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.	Baseline, 6, 12, 24 and 36 months
Relative Percent Change From Baseline of Trough Serum CTX	CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.	Baseline, 6,12, 24 and 36 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

Helpful Links

• Clinical Study Report Synopsis

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: April 19, 2004
• First Submitted That Met QC Criteria: April 20, 2004
• First Posted (Estimate): April 21, 2004

Study Record Updates

• Last Update Posted (Actual): July 14, 2017
• Last Update Submitted That Met QC Criteria: July 13, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Bone Density Conservation Agents; Ibandronic Acid
• Other Study ID Numbers: MA17903