Trial · NCT03087851
Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis
NCT03087851, Phase 4, Completed, Aarhus University Hospital; results first posted 2021-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis. Trials, record NCT03087851. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03087851
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis
- NCT number
- NCT03087851
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 61 participants, actual
- Lead sponsor
- Aarhus University Hospital
- Conditions
- Osteoporosis
- Interventions
- Zoledronic Acid
- First posted
- 2017-03-23
- Last updated
- 2021-02-21
- Results first posted
- 2021-01-14
- Limitations and caveats
Open-label design, no assessment by VFA or X-ray of VFx at baseline, changes in treatment not in accordance with the protocol. Information about BMD before initiation of DMAB is not available and the BMD loss can therefore not be evaluated in the context of the BMD gain during DMAB. Our p-CTX cutoff was 50% above the normal range for postmenopausal women and elderly men and it cannot be ruled out that the outcome of the study would have been different with a different cutoff.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Lumbar Spine BMD From Baseline to 6 Months After the Zoledronic Acid Infusion. | baseline to 6 months after the zoledronic acid infusion | Change in lumbar spine BMD from baseline to 6 months after the zoledronic acid infusion. |
| Primary | Number of Participants Who Fail to Maintain BMD | 2 years after the first ZOL treatment | Failure is defined as ≥ 3 % BMD loss at the lumbar spine |
| Secondary | Changes in BMD From Baseline to One Year After the Zoledronic Acid Infusion. | from baseline to one year after the zoledronic acid infusion | Changes in lumbar spine BMD from baseline to one year after the zoledronic acid infusion. |
| Secondary | Changes in BMD From Baseline to Two Years After the Zoledronic Acid Infusion. | from baseline to two years after the zoledronic acid infusion. | Changes in lumbar spine BMD from baseline to two years after the zoledronic acid infusion. |
| Secondary | Changes in Cortical Porosity Measured by High-resolution Peripheral Quantitative Computed Tomography (HR-pQCT) Scan at the Radius and Tibia From Baseline to One Year After the Zoledronic Acid Infusion. | from baseline to one year after the zoledronic acid infusion. | Changes in cortical porosity measured by high-resolution peripheral quantitative computed tomography (HR-pQCT) scan at the radius and tibia from baseline to one year after the zoledronic acid infusion. |
| Secondary | Changes in p-CTX From Baseline to Six Months After the Zoledronic Acid Infusion. | from baseline to six months after the zoledronic acid infusion. | Changes in p-CTX from baseline to six months after the zoledronic acid infusion. |
| Secondary | Changes in p-CTX From Baseline to 12 Months After the Zoledronic Acid Infusion. | from baseline to 12 months after the zoledronic acid infusion. | Changes in p-CTX from baseline to 12 months after the zoledronic acid infusion. |
| Secondary | Morphometric Vertebral Fractures Assessed by Vertebral Fracture Assessment (VFA) One and Two Years After the Zoledronic Acid Infusion. | one and two years after the zoledronic acid infusion. | Morphometric vertebral fractures assessed by vertebral fracture assessment (VFA) one and two years after the zoledronic acid infusion. |
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 | Change in Lumbar Spine BMD From Baseline to 6 Months After the Zoledronic Acid Infusion. | baseline to 6 months after the zoledronic acid infusion | Change in lumbar spine BMD from baseline to 6 months after the zoledronic acid infusion. | percentage change | MEAN |
| PRIMARY | Number of Participants Who Fail to Maintain BMD | 2 years after the first ZOL treatment | Number of Participants Who Fail to Maintain lumbar spine BMD from baseline to 24 months after the first ZOL | participants | NUMBER |
| SECONDARY | Changes in BMD From Baseline to One Year After the Zoledronic Acid Infusion. | from baseline to one year after the zoledronic acid infusion | Changes in lumbar spine BMD from baseline to one year after the zoledronic acid infusion. | percentage change | MEAN |
| SECONDARY | Changes in BMD From Baseline to Two Years After the Zoledronic Acid Infusion. | from baseline to two years after the zoledronic acid infusion. | Changes in lumbar spine BMD from baseline to two years after the zoledronic acid infusion. | percentage change | MEAN |
| SECONDARY | Changes in Cortical Porosity Measured by High-resolution Peripheral Quantitative Computed Tomography (HR-pQCT) Scan at the Radius and Tibia From Baseline to One Year After the Zoledronic Acid Infusion. | from baseline to one year after the zoledronic acid infusion. | Changes in cortical porosity at the radius from baseline to one year after the zoledronic acid infusion. | percentage change | MEAN |
| SECONDARY | Changes in p-CTX From Baseline to Six Months After the Zoledronic Acid Infusion. | from baseline to six months after the zoledronic acid infusion. | Changes in p-CTX from baseline to six months after the zoledronic acid infusion. | ug/l | MEAN |
| SECONDARY | Changes in p-CTX From Baseline to 12 Months After the Zoledronic Acid Infusion. | from baseline to 12 months after the zoledronic acid infusion. | Changes in p-CTX from baseline to 12 months after the zoledronic acid infusion. | ug/l | MEAN |
| SECONDARY | Morphometric Vertebral Fractures Assessed by Vertebral Fracture Assessment (VFA) One and Two Years After the Zoledronic Acid Infusion. | one and two years after the zoledronic acid infusion. | Morphometric vertebral fractures assessed by vertebral fracture assessment (VFA) two years after the zoledronic acid infusion. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Lumbar Spine BMD From Baseline to 6 Months After the Zoledronic Acid Infusion. | 6-month Group | -2.1 | Standard Error 0.9 | percentage change | |
| Change in Lumbar Spine BMD From Baseline to 6 Months After the Zoledronic Acid Infusion. | 9-months Group | -4.3 | Standard Error 1.1 | percentage change | |
| Change in Lumbar Spine BMD From Baseline to 6 Months After the Zoledronic Acid Infusion. | Observation Group | -3.0 | Standard Error 1.1 | percentage change | |
| Number of Participants Who Fail to Maintain BMD | 6-month Group | 10 | participants | ||
| Number of Participants Who Fail to Maintain BMD | 9-months Group | 5 | participants | ||
| Number of Participants Who Fail to Maintain BMD | Observation Group | 6 | participants | ||
| Changes in BMD From Baseline to One Year After the Zoledronic Acid Infusion. | 6-month Group | -4.8 | Standard Error 0.7 | percentage change | |
| Changes in BMD From Baseline to One Year After the Zoledronic Acid Infusion. | 9-months Group | -4.1 | Standard Error 1.1 | percentage change | |
| Changes in BMD From Baseline to One Year After the Zoledronic Acid Infusion. | Observation Group | -4.7 | Standard Error 1.2 | percentage change | |
| Changes in BMD From Baseline to Two Years After the Zoledronic Acid Infusion. | 6-month Group | -4.0 | Standard Error 0.8 | percentage change |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 6-month Group | 20 | |
| Overall Study | STARTED | 9-months Group | 20 | |
| Overall Study | STARTED | Observation Group | 21 | |
| Overall Study | COMPLETED | 6-month Group | 20 | |
| Overall Study | COMPLETED | 9-months Group | 19 | |
| Overall Study | COMPLETED | Observation Group | 19 | |
| Overall Study | NOT COMPLETED | 6-month Group | 0 | |
| Overall Study | NOT COMPLETED | 9-months Group | 1 | |
| Overall Study | NOT COMPLETED | Observation Group | 2 |
Source ClinicalTrials.gov
Adverse events12
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 | Flu-like symptoms after ZOL treatment | Musculoskeletal and connective tissue disorders | 6-month Group | 13 | 20 | 13 |
| other | Flu-like symptoms after ZOL treatment | Musculoskeletal and connective tissue disorders | 9-months Group | 8 | 20 | 8 |
| other | Flu-like symptoms after ZOL treatment | Musculoskeletal and connective tissue disorders | Observation Group | 16 | 21 | 16 |
| other | Infection (unspecified) + Musculoskeletal symptoms | Infections and infestations | 6-month Group | 13 | 20 | 13 |
| other | Infection (unspecified) + Musculoskeletal symptoms | Infections and infestations | 9-months Group | 18 | 20 | 18 |
| other | Infection (unspecified) + Musculoskeletal symptoms | Infections and infestations | Observation Group | 15 | 21 | 15 |
| other | Fracture | Musculoskeletal and connective tissue disorders | 6-month Group | 2 | 20 | 2 |
| other | Fracture | Musculoskeletal and connective tissue disorders | 9-months Group | 2 | 20 | 2 |
| other | Fracture | Musculoskeletal and connective tissue disorders | Observation Group | 2 | 21 | 2 |
| serious | Cancer | Investigations | 6-month Group | 0 | 20 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 6-month Group | 0 | 20 |
| Total, all-cause mortality | 9-months Group | 0 | 20 |
| Total, all-cause mortality | Observation Group | 0 | 21 |
| Total, other adverse events | 6-month Group | 18 | 20 |
| Total, other adverse events | 9-months Group | 18 | 20 |
| Total, other adverse events | Observation Group | 20 | 21 |
| Total, serious adverse events | 6-month Group | 0 | 20 |
| Total, serious adverse events | 9-months Group | 1 | 20 |
| Total, serious adverse events | Observation Group | 4 | 21 |
Source ClinicalTrials.gov
Papers9
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 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/NCT03087851
GET https://conductscience.org/api/trials/v1/NCT03087851/results?page=2