Trial · NCT00551174
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment
NCT00551174, Phase 4, Completed, Hoffmann-La Roche; results first posted 2011-05-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment. Trials, record NCT00551174. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00551174
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment
- NCT number
- NCT00551174
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 781 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Post-Menopausal Osteoporosis
- Interventions
- ibandronate [Bonviva/Boniva], ibandronate [Bonviva/Boniva]
- First posted
- 2007-10-30
- Last updated
- 2011-07-22
- Results first posted
- 2011-05-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months | Baseline,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. |
| Secondary | Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months | Baseline,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. |
| Secondary | Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months | 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 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. |
| Secondary | Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months | Baseline, 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months | Baseline,12, 24 and 36 months | ITT population: 3 mg group = 394, 2 mg group = 362. Analysis populations (AP) for Month 12: 3 mg group = 383, 2 mg group = 348; Month 24: 3 mg group = 374, 2 mg group = 332; Month 36: 3 mg group = 349, 2 mg group = 314. | Percent change | MEAN |
| SECONDARY | Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months | Baseline,12, 24 and 36 months | ITT populations: 3 mg group = 394, 2 mg group = 362. Analysis populations (AP) for Month 12: 3 mg group = 381, 2 mg group = 347; Month 24: 3 mg group = 371, 2 mg group = 330; Month 36: 3 mg group = 349, 2 mg group = 314. | Percent change | MEAN |
| SECONDARY | Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months | Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550) | Per-Protocol population: 3 mg group = 363, 2 mg group = 344. Analysis populations (AP) for Month 6: 3 mg group = 87, 2 mg group: 92; Month 12: 3 mg group = 92, 2 mg group = 92; Month 24: 3 mg group = 83, 2 mg group = 85; Month 36: 3 mg group = 75, 2 mg group = 76. | Percent change | MEAN |
| SECONDARY | Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months | Baseline, 6 months | Per-Protocol population: 3 mg group = 363, 2 mg group = 344. Analysis populations (AP) for Month 6: 3 mg group = 89, 2 mg group: 93. | Percent change | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months | 2 mg Ibandronate q2mo | Baseline | 0.7969 | Standard Deviation 0.0764 | Percent change |
| Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months | 3 mg Ibandronate q3mo | Baseline | 0.7861 | Standard Deviation 0.0824 | Percent change |
| Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months | 2 mg Ibandronate q2mo | Percent Change from Baseline at Month 12 | 0.8378 | Standard Deviation 3.1920 | Percent change |
| Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months | 3 mg Ibandronate q3mo | Percent Change from Baseline at Month 12 | 0.8845 | Standard Deviation 3.6386 | Percent change |
| Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months | 2 mg Ibandronate q2mo | Percent Change from Baseline at Month 24 | 1.6785 | Standard Deviation 3.6494 | Percent change |
| Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months | 3 mg Ibandronate q3mo | Percent Change from Baseline at Month 24 | 1.5742 | Standard Deviation 4.0665 | Percent change |
| Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months | 2 mg Ibandronate q2mo | Percent Change from Baseline at Month 36 | 1.9813 | Standard Deviation 4.6619 | Percent change |
| Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months | 3 mg Ibandronate q3mo | Percent Change from Baseline at Month 36 | 2.0559 | Standard Deviation 4.4747 | Percent change |
| Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months | 2 mg Ibandronate q2mo | Baseline | 0.7651 | Standard Deviation 0.1035 | Percent change |
| Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months | 3 mg Ibandronate q3mo | Baseline | 0.7665 | Standard Deviation 0.0954 | Percent change |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 2 mg Ibandronate q2mo | 381 | |
| Overall Study | STARTED | 3 mg Ibandronate q3mo | 400 | |
| Overall Study | COMPLETED | 2 mg Ibandronate q2mo | 362 | |
| Overall Study | COMPLETED | 3 mg Ibandronate q3mo | 394 | |
| Overall Study | NOT COMPLETED | 2 mg Ibandronate q2mo | 19 | |
| Overall Study | NOT COMPLETED | 3 mg Ibandronate q3mo | 6 |
Source ClinicalTrials.gov
Adverse events346
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 | Nasopharyngitis | Infections and infestations | 2 mg Ibandronate q2mo | 79 | 381 | |
| other | Nasopharyngitis | Infections and infestations | 3 mg Ibandronate q3mo | 67 | 400 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | 2 mg Ibandronate q2mo | 64 | 381 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | 3 mg Ibandronate q3mo | 71 | 400 | |
| other | Hypertension | Vascular disorders | 2 mg Ibandronate q2mo | 53 | 381 | |
| other | Hypertension | Vascular disorders | 3 mg Ibandronate q3mo | 59 | 400 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | 2 mg Ibandronate q2mo | 57 | 381 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | 3 mg Ibandronate q3mo | 47 | 400 | |
| other | Influenza | Infections and infestations | 2 mg Ibandronate q2mo | 42 | 381 | |
| other | Influenza | Infections and infestations | 3 mg Ibandronate q3mo | 44 | 400 |
1 to 10 of 346Source ClinicalTrials.gov
See all 346 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 2 mg Ibandronate q2mo | ||
| Total, all-cause mortality | 3 mg Ibandronate q3mo | ||
| Total, other adverse events | 2 mg Ibandronate q2mo | 265 | 381 |
| Total, other adverse events | 3 mg Ibandronate q3mo | 285 | 400 |
| Total, serious adverse events | 2 mg Ibandronate q2mo | 90 | 381 |
| Total, serious adverse events | 3 mg Ibandronate q3mo | 84 | 400 |
Source ClinicalTrials.gov
Papers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 2 mg Ibandronate q2mo vs 3 mg Ibandronate q3mo: serious adverse events |
Source Trial comparisons
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/NCT00551174
GET https://conductscience.org/api/trials/v1/NCT00551174/results?page=2