MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis

February 28, 2018 updated by: Hoffmann-La Roche

Randomized, Double-blind, Double Dummy, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of Monthly Oral Administration of 100 mg and 150 mg Ibandronate With 2.5 mg Daily Oral Ibandronate in Postmenopausal Osteoporosis

This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1609

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
      • Adelaide, Australia, 5035
      • Parkville, Australia, 3052
      • Perth, Australia, 6979
  • Belgium
      • Liege, Belgium, 4020
      • Merksem, Belgium, 2170
  • Brazil
      • Campinas, Brazil, 13077-005
      • Curitiba, Brazil, 80060-240
      • Porto Alegre, Brazil, 90035-003
      • Sao Paulo, Brazil, 04026-000
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 2N6
    • Ontario
      • Toronto, Ontario, Canada, M5S 1B2
    • Quebec
      • Quebec City, Quebec, Canada, G1V 3M7
  • Czechia
      • Plzen, Czechia, 305 99
      • Praha, Czechia, 128 00
      • Praha, Czechia, 169 02
  • Denmark
      • Aalborg, Denmark, 9000
      • Ballerup, Denmark, 2750
      • Vejle, Denmark, 7100
  • France
      • Caen, France, 14033
      • Lyon, France, 69437
  • 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
      • Valeggio Sul Mincio, Italy, 37067
  • Mexico
      • Leon, Mexico, 37000
      • Obregon, Mexico, 85100
  • Norway
      • Haugesund, Norway, 5507
      • Oslo, Norway, 0176
      • Stavanger, Norway, 4010
  • Poland
      • Krakow, Poland, 31-501
      • Warszawa, Poland, 04-730
  • Romania
      • Bucharest, Romania, 011025
  • South Africa
      • Cape Town, South Africa, 7500
      • Johannesburg, South Africa, 2196
  • Spain
      • Barcelona, Spain, 08907
      • Madrid, Spain, 28041
  • Switzerland
      • Zürich, Switzerland, 8091
  • United Kingdom
      • Cardiff, United Kingdom, CF64 2XX
      • Liverpool, United Kingdom, L22 0LG
      • London, United Kingdom, E11 1NR
      • Southampton, United Kingdom, SO16 6YD
  • United States
    • California
      • Irvine, California, United States, 92618
      • Loma Linda, California, United States, 92357
      • Los Angeles, California, United States, 90211
      • Oakland, California, United States, 94612
      • Rancho Mirage, California, United States, 92270
    • Colorado
      • Lakewood, Colorado, United States, 80227
    • Florida
      • Gainesville, Florida, United States, 32607
    • Maryland
      • Bethesda, Maryland, United States, 20817
      • Wheaton, Maryland, United States, 20902
    • Missouri
      • Saint Louis, Missouri, United States, 63110
    • Montana
      • Billings, Montana, United States, 59120
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • New Jersey
      • Livingston, New Jersey, United States, 07039
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • Oregon
      • Portland, Oregon, United States, 97213
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
    • Texas
      • San Antonio, Texas, United States, 78229
    • Virginia
      • Richmond, Virginia, United States, 23294
    • Washington
      • Seattle, Washington, United States, 98144
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women 55-80 years of age;
  • post-menopausal for >= 5 years;
  • ambulatory.

Exclusion Criteria:

  • malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
  • breast cancer within the previous 20 years;
  • allergy to bisphosphonates;
  • previous treatment with an intravenous bisphosphonate at any time;
  • previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, or >3 months of treatment within the last 2 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Ibandronate 2.5 mg
Participants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day .
Drug: Ibandronate [Bonviva/Boniva]
2.5mg po daily
Drug: Ibandronate [Bonviva/Boniva]
100mg po monthly on a single day
Drug: Ibandronate [Bonviva/Boniva]
100mg po monthly over 2 consecutive days
Drug: Ibandronate [Bonviva/Boniva]
150mg po monthly
Dietary supplement: Calcium
500 mg/day
Dietary supplement: Vitamin D
400 IU/day
Experimental: Ibandronate 50/50 mg
Participants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day.
Drug: Ibandronate [Bonviva/Boniva]
2.5mg po daily
Drug: Ibandronate [Bonviva/Boniva]
100mg po monthly on a single day
Drug: Ibandronate [Bonviva/Boniva]
100mg po monthly over 2 consecutive days
Drug: Ibandronate [Bonviva/Boniva]
150mg po monthly
Dietary supplement: Calcium
500 mg/day
Dietary supplement: Vitamin D
400 IU/day
Experimental: Ibandronate 100 mg
Participants will receive 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day
Drug: Ibandronate [Bonviva/Boniva]
2.5mg po daily
Drug: Ibandronate [Bonviva/Boniva]
100mg po monthly on a single day
Drug: Ibandronate [Bonviva/Boniva]
100mg po monthly over 2 consecutive days
Drug: Ibandronate [Bonviva/Boniva]
150mg po monthly
Dietary supplement: Calcium
500 mg/day
Dietary supplement: Vitamin D
400 IU/day
Experimental: Ibandronate 150 mg
Participants will receive 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day
Drug: Ibandronate [Bonviva/Boniva]
2.5mg po daily
Drug: Ibandronate [Bonviva/Boniva]
100mg po monthly on a single day
Drug: Ibandronate [Bonviva/Boniva]
100mg po monthly over 2 consecutive days
Drug: Ibandronate [Bonviva/Boniva]
150mg po monthly
Dietary supplement: Calcium
500 mg/day
Dietary supplement: Vitamin D
400 IU/day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density
Time Frame: From Baseline (Month 0) to Month 12
Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.
From Baseline (Month 0) to Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
Time Frame: From Baseline (Month 0) to Month 24
Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24.
From Baseline (Month 0) to Month 24
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
Time Frame: From Baseline (Month 0) to Months 12 and 24
The absolute change (g/cm^2) from baseline in mean BMD of the lumbar spine (L2 - L4) at one and two years. A difference in the mean values between the active groups and the control was calculated.
From Baseline (Month 0) to Months 12 and 24
Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
Time Frame: From Baseline (Month 0) to Months 12 and 24
Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center.
From Baseline (Month 0) to Months 12 and 24
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
Time Frame: From Baseline (Month 0) to Months 12 and 24
Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center
From Baseline (Month 0) to Months 12 and 24
Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24
Time Frame: Months 12 and 24
A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline.
Months 12 and 24
Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24
Time Frame: Months 12 and 24
A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.
Months 12 and 24
Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24
Time Frame: Months 12 and 24
A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.
Months 12 and 24
Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24
Time Frame: Months 12 and 24
A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.
Months 12 and 24
Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
Time Frame: Months 12 and 24
A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.
Months 12 and 24
Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
Time Frame: Months 12 and 24
A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.
Months 12 and 24
Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
Time Frame: Months 12 and 24
A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.
Months 12 and 24
Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24
Time Frame: From Baseline (Month 0) to Months 3, 6, 12, 24
Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
From Baseline (Month 0) to Months 3, 6, 12, 24
Absolute Change In Baseline in Serum CTX to Months 12 and 24
Time Frame: From Baseline (Month 0) to Months 12 and 24
Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
From Baseline (Month 0) to Months 12 and 24
Number of Participants With Any Adverse Events and Serious Adverse Event
Time Frame: Up to Month 24
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Up to Month 24
Number Of Participants With Marked Laboratory Abnormalities
Time Frame: Up to Month 24
Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter [g/L]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 3.0 - 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 - 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter [umol/L].
Up to Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2002

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2002

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BM16549

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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