Trial · NCT00436917
Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer
NCT00436917, Not applicable, Completed, Mayo Clinic; results first posted 2011-08-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer. Trials, record NCT00436917. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00436917
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer
- NCT number
- NCT00436917
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 60 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Breast Cancer, Osteoporosis
- Interventions
- zoledronic acid, Letrozole as adjuvant therapy
- First posted
- 2007-02-19
- Last updated
- 2019-09-11
- Results first posted
- 2011-08-12
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) | Baseline and 1 year | Change: BMD values at twelve months post study entry minus BMD values at baseline, expressed as a percentage of the baseline value. |
| Secondary | Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 2 Post Study Entry | Baseline and 2 year | Change: BMD values at year 2 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value. |
| Secondary | Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 3 Post Study Entry | Baseline and 3 year | Change: BMD values at year 3 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value. |
| Secondary | Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 4 Post Study Entry | Baseline and 4 year | Change: BMD values at year 4 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value. |
| Secondary | Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 5 Post Study Entry | Baseline and 5 year | Change: BMD values at year 5 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value. |
| Secondary | Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 1 Post Study Entry | Baseline and 1 year | Change: BMD values at year 1 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value. |
| Secondary | Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 2 Post Study Entry | Baseline and 2 year | Change: BMD values at year 2 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value. |
| Secondary | Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 3 Post Study Entry | Baseline and 3 year | Change: BMD values at year 3 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value. |
| Secondary | Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 4 Post Study Entry | Baseline and 4 year | Change: BMD values at year 4 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value. |
| Secondary | Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 5 Post Study Entry | Baseline and 5 year | Change: BMD values at year 5 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) | Baseline and 1 year | The primary analysis is performed on data where participants had the same baseline and 1 year BMD Lumbar Spine measurement location (L1-L4, L2-L4 or 'other Lumbar Spine') | Percentage of the baseline value | MEAN |
| SECONDARY | Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 2 Post Study Entry | Baseline and 2 year | Analysis was performed on data where participants had the same baseline and 2 year BMD Lumbar Spine measurement location (L1-L4, L2-L4 or 'other Lumbar Spine') | Percentage of the baseline value | MEAN |
| SECONDARY | Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 3 Post Study Entry | Baseline and 3 year | Analysis was performed on data where participants had the same baseline and 3 year BMD Lumbar Spine measurement location (L1-L4, L2-L4 or 'other Lumbar Spine') | Percentage of the baseline value | MEAN |
| SECONDARY | Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 4 Post Study Entry | Baseline and 4 year | Analysis was performed on data where participants had the same baseline and 4 year BMD Lumbar Spine measurement location (L1-L4, L2-L4 or 'other Lumbar Spine') | Percentage of the baseline value | MEAN |
| SECONDARY | Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 5 Post Study Entry | Baseline and 5 year | Analysis was performed on data where participants had the same baseline and 5 year BMD Lumbar Spine measurement location (L1-L4, L2-L4 or 'other Lumbar Spine') | Percentage of the baseline value | MEAN |
| SECONDARY | Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 1 Post Study Entry | Baseline and 1 year | Analysis was performed on data where participants had the same baseline and 1 year BMD Femoral Neck measurement location (Left femoral, right femoral) | Percentage of the baseline value | MEAN |
| SECONDARY | Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 2 Post Study Entry | Baseline and 2 year | Analysis was performed on data where participants had the same baseline and 2 year BMD Femoral Neck measurement location (Left femoral, right femoral) | Percentage of the baseline value | MEAN |
| SECONDARY | Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 3 Post Study Entry | Baseline and 3 year | Analysis was performed on data where participants had the same baseline and 3 year BMD Femoral Neck measurement location (Left femoral, right femoral) | Percentage of the baseline value | MEAN |
| SECONDARY | Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 4 Post Study Entry | Baseline and 4 year | Analysis was performed on data where participants had the same baseline and 4 year BMD Femoral Neck measurement location (Left femoral, right femoral) | Percentage of the baseline value | MEAN |
| SECONDARY | Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 5 Post Study Entry | Baseline and 5 year | Analysis was performed on data where participants had the same baseline and 5 year BMD Femoral Neck measurement location (Left femoral, right femoral) | Percentage of the baseline value | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) | Zoledronic Acid | 2.66 | 95% Confidence Interval 1.27 to 4.62 | Percentage of the baseline value | |
| Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 2 Post Study Entry | Zoledronic Acid | 4.94 | 95% Confidence Interval 2.20 to 7.68 | Percentage of the baseline value | |
| Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 3 Post Study Entry | Zoledronic Acid | 6.20 | 95% Confidence Interval 3.74 to 8.66 | Percentage of the baseline value | |
| Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 4 Post Study Entry | Zoledronic Acid | 6.99 | 95% Confidence Interval 0.80 to 13.18 | Percentage of the baseline value | |
| Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 5 Post Study Entry | Zoledronic Acid | 11.71 | 95% Confidence Interval 2.43 to 21.0 | Percentage of the baseline value | |
| Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 1 Post Study Entry | Zoledronic Acid | 5.66 | 95% Confidence Interval 1.30 to 10.02 | Percentage of the baseline value | |
| Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 2 Post Study Entry | Zoledronic Acid | 10.47 | 95% Confidence Interval 2.14 to 18.80 | Percentage of the baseline value | |
| Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 3 Post Study Entry | Zoledronic Acid | 8.44 | 95% Confidence Interval 3.45 to 13.44 | Percentage of the baseline value | |
| Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 4 Post Study Entry | Zoledronic Acid | 4.49 | 95% Confidence Interval -0.98 to 9.96 | Percentage of the baseline value | |
| Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 5 Post Study Entry | Zoledronic Acid | 4.54 | 95% Confidence Interval -3.18 to 12.26 | Percentage of the baseline value |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zoledronic Acid | 53 | |
| Overall Study | COMPLETED | Zoledronic Acid | 32 | |
| Overall Study | NOT COMPLETED | Zoledronic Acid | 21 |
Source ClinicalTrials.gov
Adverse events17
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 | Nausea | Gastrointestinal disorders | Zoledronic Acid | 6 | 52 | 7 |
| other | Vomiting | Gastrointestinal disorders | Zoledronic Acid | 2 | 52 | 2 |
| other | Fatigue | General disorders | Zoledronic Acid | 1 | 52 | 1 |
| other | Fever | General disorders | Zoledronic Acid | 4 | 52 | 4 |
| other | Creatinine increased | Investigations | Zoledronic Acid | 11 | 52 | 31 |
| other | INR increased | Investigations | Zoledronic Acid | 1 | 52 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Zoledronic Acid | 39 | 52 | 128 |
| other | Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | Zoledronic Acid | 2 | 52 | 2 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Zoledronic Acid | 1 | 52 | 1 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Zoledronic Acid | 1 | 52 | 1 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zoledronic Acid | 0 | 52 |
| Total, other adverse events | Zoledronic Acid | 45 | 52 |
| Total, serious adverse events | Zoledronic Acid | 1 | 52 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20079640 | RESULT |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT00436917
GET https://conductscience.org/api/trials/v1/NCT00436917/results?page=2