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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 781
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • St. Leonards, Australia, 2139
  • Sydney, Australia, 3129
• Belgium
  • Bruxelles, Belgium, 1180
  • Liege, Belgium, 4020
• Czech Republic
  • Plzen, Czech Republic, 305 99
  • Praha, Czech Republic, 128 00
• Denmark
  • Aalborg, Denmark, 9000
  • Ballerup, Denmark, 2750
  • København, Denmark, 1399
  • Vejle, Denmark, 7100
  • Århus, Denmark, 8000
• France
  • Lyon, France, 69000
  • Orleans, France, 45032
• Germany
  • Berlin, Germany, 12200
  • Essen, Germany, 45276
  • Hamburg, Germany, 20354
• Hungary
  • Budapest, Hungary, 1036
• Italy
  • Arenzano, Italy, 16011
  • Siena, Italy, 53100
  • Valeggio Sul Mincio, Italy, 37067
• Mexico
  • Mexico City, Mexico, 11000
  • Monterrey, Mexico, 64460
• Norway
  • Haugesund, Norway, 5507
  • Oslo, Norway, 0176
  • Stavanger, Norway, 4010
• Poland
  • Grudziadz, Poland, 86-300
  • Krakow, Poland, 31-501
  • Krakow, Poland, 30-510
• South Africa
  • Cape Town, South Africa, 7500
  • Pretoria, South Africa
  • Sommerset West, South Africa, 7129
• Spain
  • Madrid, Spain, 28046
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZD
• United States
  • Georgia
    • Gainesville, Georgia, United States, 30501
  • Missouri
    • St Louis, Missouri, United States, 63110
  • Nebraska
    • Omaha, Nebraska, United States, 68131
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
    • Fargo, North Dakota, United States, 58103
  • Wisconsin
    • Madison, Wisconsin, United States, 53792

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 2	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).; 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).
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).; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months	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.	Baseline,12, 24 and 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months	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.	Baseline,12, 24 and 36 months
Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months	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.	Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550)
Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months	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.	Baseline, 6 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: October 1, 2004
• Primary Completion (ACTUAL): November 1, 2008
• Study Completion (ACTUAL): November 1, 2008

Study Registration Dates

• First Submitted: October 29, 2007
• First Submitted That Met QC Criteria: October 29, 2007
• First Posted (ESTIMATE): October 30, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): July 22, 2011
• Last Update Submitted That Met QC Criteria: July 20, 2011
• Last Verified: July 1, 2011

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: MA17904