Trial · NCT00081653
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva
NCT00081653, Phase 4, Completed, Hoffmann-La Roche; results first posted 2009-07-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva. Trials, record NCT00081653. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00081653
On this page
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 Previously Treated With Bonviva
- NCT number
- NCT00081653
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 719 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Post-Menopausal Osteoporosis
- Interventions
- ibandronate [Bonviva/Boniva], ibandronate [Bonviva/Boniva]
- First posted
- 2004-04-21
- Last updated
- 2017-07-14
- Results first posted
- 2009-07-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Baseline and Months 12, 24 and 36 | Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm\^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]). |
| Primary | Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD) | Baseline and Months 12, 24 and 36 | BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae \[L2-L4\] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]). |
| Secondary | Absolute Change From Baseline in Mean Total Hip BMD | Baseline and 12, 24 and 36 months | BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones). |
| Secondary | Relative Percent Change From Baseline in Mean Total Hip BMD | Baseline, 12, 24 and 36 months | BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones). |
| Secondary | Absolute Change From Baseline of Trough Serum CTX | Baseline, 6, 12, 24 and 36 months | CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values. |
| Secondary | Relative Percent Change From Baseline of Trough Serum CTX | Baseline, 6,12, 24 and 36 months | CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Absolute Change From Baseline in Mean Total Hip BMD | Baseline and 12, 24 and 36 months | ITT Population; n = number of participants analyzed for the given parameter at the specified visit. | g/cm^2 | MEAN |
| SECONDARY | Relative Percent Change From Baseline in Mean Total Hip BMD | Baseline, 12, 24 and 36 months | ITT Population; n = number of participants analyzed for the given parameter at the specified visit. | percent change in BMD | MEAN |
| SECONDARY | Absolute Change From Baseline of Trough Serum CTX | Baseline, 6, 12, 24 and 36 months | ITT population; n = number of participants analyzed for the given parameter at the specified visit. | ng/mL | MEAN |
| PRIMARY | Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD | Baseline and Months 12, 24 and 36 | ITT population; number (n) equals (=) number of participants analyzed at the specified visit. | g/cm^2 | MEAN |
| PRIMARY | Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD) | Baseline and Months 12, 24 and 36 | ITT population: n = number of participants analyzed for the given parameter at the specified visit. | percent change | MEAN |
| SECONDARY | Relative Percent Change From Baseline of Trough Serum CTX | Baseline, 6,12, 24 and 36 months | ITT population; n = number of participants analyzed for the given parameter at the specified visit. | percent change | MEAN |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change From Baseline in Mean Total Hip BMD | Ibandronate 100 mg | Baseline (n=345,348) | 0.7680 | Standard Deviation 0.1093 | g/cm^2 |
| Absolute Change From Baseline in Mean Total Hip BMD | Ibandronate 150 mg | Baseline (n=345,348) | 0.7862 | Standard Deviation 0.1112 | g/cm^2 |
| Absolute Change From Baseline in Mean Total Hip BMD | Ibandronate 100 mg | Month 12 (n=347,346) | 0.7669 | Standard Deviation 0.1097 | g/cm^2 |
| Absolute Change From Baseline in Mean Total Hip BMD | Ibandronate 150 mg | Month 12 (n=347,346) | 0.7888 | Standard Deviation 0.1116 | g/cm^2 |
| Absolute Change From Baseline in Mean Total Hip BMD | Ibandronate 100 mg | Change from Baseline at Month 12 (n=344,345) | -0.0004 | Standard Deviation 0.0204 | g/cm^2 |
| Absolute Change From Baseline in Mean Total Hip BMD | Ibandronate 150 mg | Change from Baseline at Month 12 (n=344,345) | 0.0025 | Standard Deviation 0.0200 | g/cm^2 |
| Absolute Change From Baseline in Mean Total Hip BMD | Ibandronate 100 mg | Month 24 (n=322,336) | 0.7686 | Standard Deviation 0.1104 | g/cm^2 |
| Absolute Change From Baseline in Mean Total Hip BMD | Ibandronate 150 mg | Month 24 (n=322,336) | 0.7882 | Standard Deviation 0.1124 | g/cm^2 |
| Absolute Change From Baseline in Mean Total Hip BMD | Ibandronate 100 mg | Change from Baseline at Month 24 (n=319,335) | -0.0010 | Standard Deviation 0.0227 | g/cm^2 |
| Absolute Change From Baseline in Mean Total Hip BMD | Ibandronate 150 mg | Change from Baseline at Month 24 (n=319,335) | 0.0031 | Standard Deviation 0.0214 | g/cm^2 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibandronate 100 Milligrams (mg) | 358 | |
| Overall Study | STARTED | Ibandronate 150 mg | 361 | |
| Overall Study | COMPLETED | Ibandronate 100 Milligrams (mg) | 311 | |
| Overall Study | COMPLETED | Ibandronate 150 mg | 324 | |
| Overall Study | NOT COMPLETED | Ibandronate 100 Milligrams (mg) | 47 | |
| Overall Study | NOT COMPLETED | Ibandronate 150 mg | 37 |
Source ClinicalTrials.gov
Adverse events284
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 | Ibandronate 100 mg | 46 | 358 | |
| other | Nasopharyngitis | Infections and infestations | Ibandronate 150 mg | 40 | 361 | |
| other | Urinary tract infection | Infections and infestations | Ibandronate 100 mg | 22 | 358 | |
| other | Urinary tract infection | Infections and infestations | Ibandronate 150 mg | 27 | 361 | |
| other | Bronchitis | Infections and infestations | Ibandronate 100 mg | 24 | 358 | |
| other | Bronchitis | Infections and infestations | Ibandronate 150 mg | 21 | 361 | |
| other | Influenza | Infections and infestations | Ibandronate 100 mg | 22 | 358 | |
| other | Influenza | Infections and infestations | Ibandronate 150 mg | 15 | 361 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ibandronate 100 mg | 32 | 358 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ibandronate 150 mg | 31 | 361 |
1 to 10 of 284Source ClinicalTrials.gov
See all 284 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibandronate 100 mg | ||
| Total, all-cause mortality | Ibandronate 150 mg | ||
| Total, other adverse events | Ibandronate 100 mg | 187 | 358 |
| Total, other adverse events | Ibandronate 150 mg | 185 | 361 |
| Total, serious adverse events | Ibandronate 100 mg | 68 | 358 |
| Total, serious adverse events | Ibandronate 150 mg | 70 | 361 |
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 |
|---|
| Ibandronate 100 mg vs Ibandronate 150 mg: 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/NCT00081653
GET https://conductscience.org/api/trials/v1/NCT00081653/results?page=2