Trial · NCT00503113
A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
NCT00503113, Phase 4, Completed, Hoffmann-La Roche; results first posted 2011-06-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease. Trials, record NCT00503113. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00503113
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
- NCT number
- NCT00503113
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 801 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Post-Menopausal Osteoporosis
- Interventions
- ibandronate [Bonviva/Boniva], ibandronate [Bonviva/Boniva], Alendronate
- First posted
- 2007-07-18
- Last updated
- 2011-06-17
- Results first posted
- 2011-06-17
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) | Baseline and 9 months | The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment. |
| Secondary | Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula) | Baseline and 9 months | Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault \[CG\] formula) after 9 months (or 40 weeks) of treatment. |
| Secondary | Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula) | Baseline and 9 months | Change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment. |
| Secondary | Relative Change From Baseline in Actual GFR (Using CG Formula) | Baseline and 9 months | Change (mL/min) from baseline in actual GFR (CG formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment. |
| Secondary | Absolute Change From Baseline in Mean Serum Creatinine. | Baseline and 9 months | |
| Secondary | Relative Change From Baseline in Mean Serum Creatinine. | Baseline and 9 months | |
| Secondary | Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio. | Baseline and 9 months | |
| Secondary | Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio. | Baseline and 9 months | The relative change from baseline in this case is positively skewed (while the absolute change is not) and the means tends to more positive values. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) | Baseline and 9 months | Per Protocol (PP) Population | mL/min | MEAN |
| SECONDARY | Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula) | Baseline and 9 months | PP Population | mL/min | MEAN |
| SECONDARY | Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula) | Baseline and 9 months | PP Population | mL/min | MEAN |
| SECONDARY | Relative Change From Baseline in Actual GFR (Using CG Formula) | Baseline and 9 months | PP Population | mL/min | MEAN |
| SECONDARY | Absolute Change From Baseline in Mean Serum Creatinine. | Baseline and 9 months | PP Population | mg/dL | MEAN |
| SECONDARY | Relative Change From Baseline in Mean Serum Creatinine. | Baseline and 9 months | PP Population | mg/dL | MEAN |
| SECONDARY | Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio. | Baseline and 9 months | PP Population | mg/g | MEAN |
| SECONDARY | Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio. | Baseline and 9 months | PP Population | mg/g | MEAN |
Source ClinicalTrials.gov
Results by group48
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 Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) | Ibandronate 3 mg Injection | Baseline | 72.5 | Standard Deviation 18.25 | mL/min |
| Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) | Ibandronate 3 mg Infusion | Baseline | 71.5 | Standard Deviation 18.07 | mL/min |
| Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) | Alendronate 70 mg Oral | Baseline | 70.5 | Standard Deviation 16.67 | mL/min |
| Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) | Ibandronate 3 mg Injection | Change from baseline at 9 months (n=233,232,225) | -1.3 | Standard Deviation 7.14 | mL/min |
| Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) | Ibandronate 3 mg Infusion | Change from baseline at 9 months (n=233,232,225) | -0.5 | Standard Deviation 7.86 | mL/min |
| Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) | Alendronate 70 mg Oral | Change from baseline at 9 months (n=233,232,225) | -1.6 | Standard Deviation 5.89 | mL/min |
| Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula) | Ibandronate 3 mg Injection | Baseline | 65.0 | Standard Deviation 19.37 | mL/min |
| Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula) | Ibandronate 3 mg Infusion | Baseline | 62.9 | Standard Deviation 18.22 | mL/min |
| Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula) | Alendronate 70 mg Oral | Baseline | 62.0 | Standard Deviation 16.67 | mL/min |
| Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula) | Ibandronate 3 mg Injection | Change from Baseline at 9 months (N=233,232,225) | -1.6 | Standard Deviation 5.89 | mL/min |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibandronate 3 mg Injection | 268 | |
| Overall Study | STARTED | Ibandronate 3 mg Infusion | 264 | |
| Overall Study | STARTED | Alendronate 70 mg Oral | 269 | |
| Overall Study | Intent to Treat Population (ITT) | Ibandronate 3 mg Injection | 262 | |
| Overall Study | Intent to Treat Population (ITT) | Ibandronate 3 mg Infusion | 261 | |
| Overall Study | Intent to Treat Population (ITT) | Alendronate 70 mg Oral | 268 | |
| Overall Study | Per Protocol Population (PP) | Ibandronate 3 mg Injection | 246 | |
| Overall Study | Per Protocol Population (PP) | Ibandronate 3 mg Infusion | 243 | |
| Overall Study | Per Protocol Population (PP) | Alendronate 70 mg Oral | 241 | |
| Overall Study | Safety Population | Ibandronate 3 mg Injection | 263 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events288
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 | Influenza | Infections and infestations | Ibandronate 3 mg Injection | 37 | 263 | |
| other | Influenza | Infections and infestations | Ibandronate 3 mg Infusion | 32 | 263 | |
| other | Influenza | Infections and infestations | Alendronate 70 mg Oral | 30 | 267 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Ibandronate 3 mg Injection | 26 | 263 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Ibandronate 3 mg Infusion | 29 | 263 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Alendronate 70 mg Oral | 25 | 267 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ibandronate 3 mg Injection | 22 | 263 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ibandronate 3 mg Infusion | 28 | 263 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Alendronate 70 mg Oral | 27 | 267 | |
| other | Hypertension | Vascular disorders | Ibandronate 3 mg Injection | 23 | 263 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibandronate 3 mg Injection | ||
| Total, all-cause mortality | Ibandronate 3 mg Infusion | ||
| Total, all-cause mortality | Alendronate 70 mg Oral | ||
| Total, other adverse events | Ibandronate 3 mg Injection | 196 | 263 |
| Total, other adverse events | Ibandronate 3 mg Infusion | 190 | 263 |
| Total, other adverse events | Alendronate 70 mg Oral | 191 | 267 |
| Total, serious adverse events | Ibandronate 3 mg Injection | 19 | 263 |
| Total, serious adverse events | Ibandronate 3 mg Infusion | 15 | 263 |
| Total, serious adverse events | Alendronate 70 mg Oral | 13 | 267 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34231877 | DERIVED |
Source PubMed
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/NCT00503113
GET https://conductscience.org/api/trials/v1/NCT00503113/results?page=2