Trial · NCT00048074
DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
NCT00048074, Phase 3, Completed, Hoffmann-La Roche; results first posted 2016-02-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis. Trials, record NCT00048074. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00048074
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
- NCT number
- NCT00048074
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,395 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Post Menopausal Osteoporosis
- Interventions
- ibandronate [Bonviva/Boniva], ibandronate [Bonviva/Boniva], ibandronate [Bonviva/Boniva]
- First posted
- 2002-10-25
- Last updated
- 2016-02-03
- Results first posted
- 2016-02-03
Source ClinicalTrials.gov
Registered outcomes16
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 Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months | Baseline and Month 12 | BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 12. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline) |
| Secondary | Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months | Baseline and Month 24 | BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 24. The change in BMD was defined as the relative difference between the last individual measurement available at 24 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline) |
| Secondary | Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24 | Baseline, Month 12 and Month 24 | BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at screening, Month 12 and Month 24. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed. |
| Secondary | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Baseline, Month 12 and Month 24 | BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24.The change in BMD of the proximal femur (total hip, trochanter, femoral neck) was defined as the relative difference between the last individual measurement available at Month 12 or Month 24and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year/2year - BMD at Baseline) / (BMD at Baseline). BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed. |
| Secondary | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Baseline, Month 12 and Month 24 | BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24. The absolute change in BMD was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed. |
| Secondary | Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24 | Baseline, At Month 6, 12, and 24. | Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The change in serum CTX was defined as the relative difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline, using the following formula: Relative change = 100 x (CTX at Month 6/Month 12/Month 24- CTX at Baseline) / (CTX at Baseline). Only participants with data available at particular timepoint were analyzed. |
| Secondary | Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24 | Baseline, At Month 6, 12, and 24. | Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The absolute change from Baseline in serum CTX was defined as the difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed. |
| Secondary | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24 | At Month 12 and 24 | A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. |
| Secondary | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24 | At Month 12 and 24 | A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. |
| Secondary | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24 | At Month 12 and 24 | A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed. |
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 Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months | Baseline and Month 12 | Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. | Percent Change | MEAN |
| SECONDARY | Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months | Baseline and Month 24 | Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. | Percent Change | MEAN |
| SECONDARY | Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24 | Baseline, Month 12 and Month 24 | Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. | Absolute Change (g/cm^2) | MEAN |
| SECONDARY | Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Baseline, Month 12 and Month 24 | Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. | Percent Change | MEAN |
| SECONDARY | Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24 | Baseline, Month 12 and Month 24 | Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. | Absolute Change (g/cm^2) | MEAN |
| SECONDARY | Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24 | Baseline, At Month 6, 12, and 24. | Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. | Percent Change | MEAN |
| SECONDARY | Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24 | Baseline, At Month 6, 12, and 24. | Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. | Absolute Change (ng/mL) | MEAN |
| SECONDARY | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24 | At Month 12 and 24 | Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24 | At Month 12 and 24 | Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24 | At Month 12 and 24 | Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol. | Percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group171
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 Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months | Ibandronate 2.5mg Daily | 3.8199 | Standard Deviation 3.8576 | Percent Change | |
| Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months | Ibandronate 2mg q 2 mo IV | 5.0872 | Standard Deviation 3.8746 | Percent Change | |
| Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months | Ibandronate 3mg q 3 mo IV | 4.8188 | Standard Deviation 3.7613 | Percent Change | |
| Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months | Ibandronate 2.5mg Daily | 4.8412 | Standard Deviation 4.8654 | Percent Change | |
| Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months | Ibandronate 2mg q 2 mo IV | 6.3999 | Standard Deviation 4.7392 | Percent Change | |
| Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months | Ibandronate 3mg q 3 mo IV | 6.2777 | Standard Deviation 5.0049 | Percent Change | |
| Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24 | Ibandronate 2.5mg Daily | Month 12, n= 368, 350, 359 | 0.028 | Standard Deviation 0.0287 | Absolute Change (g/cm^2) |
| Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24 | Ibandronate 2mg q 2 mo IV | Month 12, n= 368, 350, 359 | 0.037 | Standard Deviation 0.0282 | Absolute Change (g/cm^2) |
| Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24 | Ibandronate 3mg q 3 mo IV | Month 12, n= 368, 350, 359 | 0.035 | Standard Deviation 0.0269 | Absolute Change (g/cm^2) |
| Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24 | Ibandronate 2.5mg Daily | Month 24, n= 334, 320, 334 | 0.036 | Standard Deviation 0.0361 | Absolute Change (g/cm^2) |
1 to 10 of 171Source ClinicalTrials.gov
See all 171 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibandronate 2.5mg Daily | 465 | |
| Overall Study | STARTED | Ibandronate 2mg q 2 mo IV | 448 | |
| Overall Study | STARTED | Ibandronate 3mg q 3 mo IV | 469 | |
| Overall Study | COMPLETED | Ibandronate 2.5mg Daily | 384 | |
| Overall Study | COMPLETED | Ibandronate 2mg q 2 mo IV | 361 | |
| Overall Study | COMPLETED | Ibandronate 3mg q 3 mo IV | 372 | |
| Overall Study | NOT COMPLETED | Ibandronate 2.5mg Daily | 81 | |
| Overall Study | NOT COMPLETED | Ibandronate 2mg q 2 mo IV | 87 | |
| Overall Study | NOT COMPLETED | Ibandronate 3mg q 3 mo IV | 97 |
Source ClinicalTrials.gov
Adverse events588
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 2.5mg Daily | 65 | 465 | |
| other | Nasopharyngitis | Infections and infestations | Ibandronate 2mg q 2 mo IV | 66 | 448 | |
| other | Nasopharyngitis | Infections and infestations | Ibandronate 3mg q 3 mo IV | 43 | 469 | |
| other | Influenza | Infections and infestations | Ibandronate 2.5mg Daily | 51 | 465 | |
| other | Influenza | Infections and infestations | Ibandronate 2mg q 2 mo IV | 43 | 448 | |
| other | Influenza | Infections and infestations | Ibandronate 3mg q 3 mo IV | 35 | 469 | |
| other | Bronchitis | Infections and infestations | Ibandronate 2.5mg Daily | 23 | 465 | |
| other | Bronchitis | Infections and infestations | Ibandronate 2mg q 2 mo IV | 28 | 448 | |
| other | Bronchitis | Infections and infestations | Ibandronate 3mg q 3 mo IV | 22 | 469 | |
| other | Urinary tract infection | Infections and infestations | Ibandronate 2.5mg Daily | 28 | 465 |
1 to 10 of 588Source ClinicalTrials.gov
See all 588 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibandronate 2.5mg Daily | ||
| Total, all-cause mortality | Ibandronate 2mg q 2 mo IV | ||
| Total, all-cause mortality | Ibandronate 3mg q 3 mo IV | ||
| Total, other adverse events | Ibandronate 2.5mg Daily | 301 | 465 |
| Total, other adverse events | Ibandronate 2mg q 2 mo IV | 316 | 448 |
| Total, other adverse events | Ibandronate 3mg q 3 mo IV | 284 | 469 |
| Total, serious adverse events | Ibandronate 2.5mg Daily | 67 | 465 |
| Total, serious adverse events | Ibandronate 2mg q 2 mo IV | 73 | 448 |
| Total, serious adverse events | Ibandronate 3mg q 3 mo IV | 62 | 469 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21975558 | 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/NCT00048074
GET https://conductscience.org/api/trials/v1/NCT00048074/results?page=2