Trial · NCT00936897
A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates
NCT00936897, Phase 3, Completed, Amgen; results first posted 2012-11-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates. Trials, record NCT00936897. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00936897
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates
- NCT number
- NCT00936897
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 833 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Postmenopausal Osteoporosis
- Interventions
- Ibandronate, Denosumab
- First posted
- 2009-07-10
- Last updated
- 2013-02-11
- Results first posted
- 2012-11-29
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Hip Bone Mineral Density Percent Change From Baseline at Month 12 | Baseline to month 12 | |
| Secondary | Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1 | Baseline to month 1 | |
| Secondary | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12 | Baseline to Month 12 | |
| Secondary | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 | Baseline to month 12 |
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 | Total Hip Bone Mineral Density Percent Change From Baseline at Month 12 | Baseline to month 12 | All randomized subjects using regression imputation for missing post baseline data. | Percentage Change From Baseline | MEAN |
| SECONDARY | Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1 | Baseline to month 1 | Randomized subjects who enrolled in the bone marker substudy | Percentage Change From Baseline | MEDIAN |
| SECONDARY | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12 | Baseline to Month 12 | All randomized subjects using regression imputation for missing post baseline data | Percentage Change From Baseline | MEAN |
| SECONDARY | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 | Baseline to month 12 | All randomized subjects using regression imputation for missing post baseline data | Percentage Change From Baseline | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Hip Bone Mineral Density Percent Change From Baseline at Month 12 | Denosumab 60 mg SC Q6M | 2.2 | 95% Confidence Interval 2.0 to 2.5 | Percentage Change From Baseline | |
| Total Hip Bone Mineral Density Percent Change From Baseline at Month 12 | Ibandronate 150 mg PO QM | 0.9 | 95% Confidence Interval 0.6 to 1.1 | Percentage Change From Baseline | |
| Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1 | Denosumab 60 mg SC Q6M | -81.1 | Inter-Quartile Range -88.0 to -70.9 | Percentage Change From Baseline | |
| Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1 | Ibandronate 150 mg PO QM | -35.0 | Inter-Quartile Range -51.9 to -15.3 | Percentage Change From Baseline | |
| Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12 | Denosumab 60 mg SC Q6M | 1.7 | 95% Confidence Interval 1.3 to 2.1 | Percentage Change From Baseline | |
| Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12 | Ibandronate 150 mg PO QM | 0.5 | 95% Confidence Interval 0.1 to 0.9 | Percentage Change From Baseline | |
| Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 | Denosumab 60 mg SC Q6M | 4.1 | 95% Confidence Interval 3.7 to 4.5 | Percentage Change From Baseline | |
| Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 | Ibandronate 150 mg PO QM | 2.1 | 95% Confidence Interval 1.7 to 2.5 | Percentage Change From Baseline |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Denosumab 60 mg SC Q6M | 417 | |
| Overall Study | STARTED | Ibandronate 150 mg PO QM | 416 | |
| Overall Study | COMPLETED | Denosumab 60 mg SC Q6M | 398 | |
| Overall Study | COMPLETED | Ibandronate 150 mg PO QM | 356 | |
| Overall Study | NOT COMPLETED | Denosumab 60 mg SC Q6M | 19 | |
| Overall Study | NOT COMPLETED | Ibandronate 150 mg PO QM | 60 |
Source ClinicalTrials.gov
Adverse events152
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 | Upper respiratory tract infection | Infections and infestations | Ibandronate 150 mg PO QM | 9 | 410 | |
| other | Upper respiratory tract infection | Infections and infestations | Denosumab 60 mg SC Q6M | 21 | 411 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ibandronate 150 mg PO QM | 23 | 410 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Denosumab 60 mg SC Q6M | 25 | 411 | |
| serious | Atrial fibrillation | Cardiac disorders | Ibandronate 150 mg PO QM | 0 | 410 | |
| serious | Atrial fibrillation | Cardiac disorders | Denosumab 60 mg SC Q6M | 2 | 411 | |
| serious | Atrioventricular block complete | Cardiac disorders | Ibandronate 150 mg PO QM | 1 | 410 | |
| serious | Atrioventricular block complete | Cardiac disorders | Denosumab 60 mg SC Q6M | 0 | 411 | |
| serious | Bradycardia | Cardiac disorders | Ibandronate 150 mg PO QM | 0 | 410 | |
| serious | Bradycardia | Cardiac disorders | Denosumab 60 mg SC Q6M | 2 | 411 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibandronate 150 mg PO QM | ||
| Total, all-cause mortality | Denosumab 60 mg SC Q6M | ||
| Total, other adverse events | Ibandronate 150 mg PO QM | 31 | 410 |
| Total, other adverse events | Denosumab 60 mg SC Q6M | 42 | 411 |
| Total, serious adverse events | Ibandronate 150 mg PO QM | 22 | 410 |
| Total, serious adverse events | Denosumab 60 mg SC Q6M | 39 | 411 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 150 mg PO QM vs Denosumab 60 mg SC Q6M: 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/NCT00936897
GET https://conductscience.org/api/trials/v1/NCT00936897/events?page=2