Trial · NCT00048061
MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
NCT00048061, Phase 3, Completed, Hoffmann-La Roche; results first posted 2016-05-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis. Trials, record NCT00048061. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00048061
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
- NCT number
- NCT00048061
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,609 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Post Menopausal Osteoporosis
- Interventions
- Ibandronate [Bonviva/Boniva], Ibandronate [Bonviva/Boniva], Ibandronate [Bonviva/Boniva], Ibandronate [Bonviva/Boniva], Calcium, Vitamin D
- First posted
- 2002-10-25
- Last updated
- 2018-03-29
- Results first posted
- 2016-05-30
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density | 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. |
| Secondary | Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | 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. |
| Secondary | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | 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. |
| Secondary | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | 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. |
| Secondary | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | 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 |
| Secondary | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24 | 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. |
| Secondary | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. |
| Secondary | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. |
| Secondary | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. |
| Secondary | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density | From Baseline (Month 0) to Month 12 | The per-protocol(PP) population included participants in Intent-to-treat(ITT) population who were randomized, received at least one dose of medication and had at least one valid efficacy(BMD or Serum CTX)follow-up data point;defined as any measurement that can be scientifically compared to baseline measurement, and had no major protocol violations. | Percent change | MEAN |
| SECONDARY | Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | From Baseline (Month 0) to Month 24 | The PP population consisted of all participants in the ITT population who had no major violations of the protocol.Participants available at particular time point for assessment were included in the analysis. | Percent change | MEAN |
| SECONDARY | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | From Baseline (Month 0) to Months 12 and 24 | The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. | g/cm2 | MEAN |
| SECONDARY | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | From Baseline (Month 0) to Months 12 and 24 | The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. | Percent change | MEAN |
| SECONDARY | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | From Baseline (Month 0) to Months 12 and 24 | The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. | g/cm2 | MEAN |
| SECONDARY | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment. | Percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group208
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density | Ibandronate 2.5 mg | 3.7427 | Standard Deviation 4.0149 | Percent change | |
| Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density | Ibandronate 50/50 mg | 4.3395 | Standard Deviation 3.9557 | Percent change | |
| Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density | Ibandronate 100 mg | 4.0328 | Standard Deviation 3.6815 | Percent change | |
| Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density | Ibandronate 150 mg | 4.7611 | Standard Deviation 3.8931 | Percent change | |
| Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | Ibandronate 2.5 mg | 4.9623 | Standard Deviation 4.6525 | Percent change | |
| Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | Ibandronate 50/50 mg | 5.3350 | Standard Deviation 4.8235 | Percent change | |
| Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | Ibandronate 100 mg | 5.5760 | Standard Deviation 4.2280 | Percent change | |
| Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | Ibandronate 150 mg | 6.5503 | Standard Deviation 4.5118 | Percent change | |
| Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | Ibandronate 2.5 mg | At 12 months, n = 314, 322, 306, 314 | 0.028 | Standard Deviation 0.0291 | g/cm2 |
| Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | Ibandronate 50/50 mg | At 12 months, n = 314, 322, 306, 314 | 0.033 | Standard Deviation 0.0298 | g/cm2 |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibandronate 2.5 mg | 400 | |
| Overall Study | STARTED | Ibandronate 50/50 mg | 401 | |
| Overall Study | STARTED | Ibandronate 100 mg | 400 | |
| Overall Study | STARTED | Ibandronate 150 mg | 401 | |
| Overall Study | COMPLETED | Ibandronate 2.5 mg | 325 | |
| Overall Study | COMPLETED | Ibandronate 50/50 mg | 328 | |
| Overall Study | COMPLETED | Ibandronate 100 mg | 316 | |
| Overall Study | COMPLETED | Ibandronate 150 mg | 322 | |
| Overall Study | NOT COMPLETED | Ibandronate 2.5 mg | 75 | |
| Overall Study | NOT COMPLETED | Ibandronate 50/50 mg | 73 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events724
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ibandronate 2.5 mg | 24 | 395 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ibandronate 50/50 mg | 39 | 396 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ibandronate 100 mg | 35 | 396 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ibandronate 150 mg | 27 | 396 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Ibandronate 2.5 mg | 25 | 395 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Ibandronate 50/50 mg | 36 | 396 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Ibandronate 100 mg | 36 | 396 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Ibandronate 150 mg | 28 | 396 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Ibandronate 2.5 mg | 9 | 395 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Ibandronate 50/50 mg | 14 | 396 |
1 to 10 of 724Source ClinicalTrials.gov
See all 724 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibandronate 2.5 mg | ||
| Total, all-cause mortality | Ibandronate 50/50 mg | ||
| Total, all-cause mortality | Ibandronate 100 mg | ||
| Total, all-cause mortality | Ibandronate 150 mg | ||
| Total, other adverse events | Ibandronate 2.5 mg | 190 | 395 |
| Total, other adverse events | Ibandronate 50/50 mg | 190 | 396 |
| Total, other adverse events | Ibandronate 100 mg | 191 | 396 |
| Total, other adverse events | Ibandronate 150 mg | 182 | 396 |
| Total, serious adverse events | Ibandronate 2.5 mg | 38 | 395 |
| Total, serious adverse events | Ibandronate 50/50 mg | 54 | 396 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00048061
GET https://conductscience.org/api/trials/v1/NCT00048061/results?page=2