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

Primary Purpose

Post Menopausal Osteoporosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ibandronate [Bonviva/Boniva]
Ibandronate [Bonviva/Boniva]
Ibandronate [Bonviva/Boniva]
Ibandronate [Bonviva/Boniva]
Calcium
Vitamin D
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Menopausal Osteoporosis

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Ibandronate 2.5 mg

Ibandronate 50/50 mg

Ibandronate 100 mg

Ibandronate 150 mg

Arm Description

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 .

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.

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

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

Outcomes

Primary Outcome Measures

Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density
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.

Secondary Outcome Measures

Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
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.
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
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.
Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
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.
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
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
Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at 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.
Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.
Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.
Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.
Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at 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.
Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at 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.
Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at 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.
Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 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).
Absolute Change In Baseline in Serum CTX 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).
Number of Participants With Any Adverse Events and Serious Adverse Event
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.
Number Of Participants With Marked Laboratory Abnormalities
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].

Full Information

First Posted
October 24, 2002
Last Updated
February 28, 2018
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00048061
Brief Title
MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Menopausal Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1609 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibandronate 2.5 mg
Arm Type
Active Comparator
Arm Description
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 .
Arm Title
Ibandronate 50/50 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Ibandronate 100 mg
Arm Type
Experimental
Arm Description
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
Arm Title
Ibandronate 150 mg
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ibandronate [Bonviva/Boniva]
Intervention Description
2.5mg po daily
Intervention Type
Drug
Intervention Name(s)
Ibandronate [Bonviva/Boniva]
Intervention Description
100mg po monthly on a single day
Intervention Type
Drug
Intervention Name(s)
Ibandronate [Bonviva/Boniva]
Intervention Description
100mg po monthly over 2 consecutive days
Intervention Type
Drug
Intervention Name(s)
Ibandronate [Bonviva/Boniva]
Intervention Description
150mg po monthly
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium
Intervention Description
500 mg/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
400 IU/day
Primary Outcome Measure Information:
Title
Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density
Description
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.
Time Frame
From Baseline (Month 0) to Month 12
Secondary Outcome Measure Information:
Title
Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
Description
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.
Time Frame
From Baseline (Month 0) to Month 24
Title
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
Description
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.
Time Frame
From Baseline (Month 0) to Months 12 and 24
Title
Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
Description
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.
Time Frame
From Baseline (Month 0) to Months 12 and 24
Title
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
Description
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
Time Frame
From Baseline (Month 0) to Months 12 and 24
Title
Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24
Description
A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline.
Time Frame
Months 12 and 24
Title
Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24
Description
A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.
Time Frame
Months 12 and 24
Title
Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24
Description
A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.
Time Frame
Months 12 and 24
Title
Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24
Description
A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.
Time Frame
Months 12 and 24
Title
Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
Description
A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.
Time Frame
Months 12 and 24
Title
Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
Description
A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.
Time Frame
Months 12 and 24
Title
Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
Description
A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.
Time Frame
Months 12 and 24
Title
Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24
Description
Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
Time Frame
From Baseline (Month 0) to Months 3, 6, 12, 24
Title
Absolute Change In Baseline in Serum CTX to Months 12 and 24
Description
Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
Time Frame
From Baseline (Month 0) to Months 12 and 24
Title
Number of Participants With Any Adverse Events and Serious Adverse Event
Description
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.
Time Frame
Up to Month 24
Title
Number Of Participants With Marked Laboratory Abnormalities
Description
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].
Time Frame
Up to Month 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80227
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Billings
State/Province
Montana
ZIP/Postal Code
59120
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
City
Adelaide
ZIP/Postal Code
5035
Country
Australia
City
Parkville
ZIP/Postal Code
3052
Country
Australia
City
Perth
ZIP/Postal Code
6979
Country
Australia
City
Liege
ZIP/Postal Code
4020
Country
Belgium
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
City
Campinas
ZIP/Postal Code
13077-005
Country
Brazil
City
Curitiba
ZIP/Postal Code
80060-240
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
90035-003
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04026-000
Country
Brazil
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2N6
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
City
Plzen
ZIP/Postal Code
305 99
Country
Czechia
City
Praha
ZIP/Postal Code
128 00
Country
Czechia
City
Praha
ZIP/Postal Code
169 02
Country
Czechia
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
City
Caen
ZIP/Postal Code
14033
Country
France
City
Lyon
ZIP/Postal Code
69437
Country
France
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Hannover
ZIP/Postal Code
30167
Country
Germany
City
Balatonfuered
ZIP/Postal Code
8230
Country
Hungary
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
City
Kiskunhalas
ZIP/Postal Code
6400
Country
Hungary
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
City
Siena
ZIP/Postal Code
53100
Country
Italy
City
Valeggio Sul Mincio
ZIP/Postal Code
37067
Country
Italy
City
Leon
ZIP/Postal Code
37000
Country
Mexico
City
Obregon
ZIP/Postal Code
85100
Country
Mexico
City
Haugesund
ZIP/Postal Code
5507
Country
Norway
City
Oslo
ZIP/Postal Code
0176
Country
Norway
City
Stavanger
ZIP/Postal Code
4010
Country
Norway
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
City
Bucharest
ZIP/Postal Code
011025
Country
Romania
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
City
Johannesburg
ZIP/Postal Code
2196
Country
South Africa
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Cardiff
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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