Trial · NCT00439647
Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
NCT00439647, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-11-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis. Trials, record NCT00439647. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00439647
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
- NCT number
- NCT00439647
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,199 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Male Osteoporosis
- Interventions
- Zoledronic acid 5 mg iv, Placebo
- First posted
- 2007-02-23
- Last updated
- 2017-04-21
- Results first posted
- 2011-11-16
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months | 24 Months | Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height |
| Secondary | Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months | 12 Months | Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height |
| Secondary | Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months | 12 months | Moderate or severe vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. Grade 2 moderate VF was defined as a 25-40% reduction in any vertebral height.Grade 3 Severe: VF was defined as more than 40% reduction in any vertebral height. |
| Secondary | Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months | 24 Months | Moderate or severe vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. Grade 2 moderate VF was defined as a 25-40% reduction in any vertebral height.Grade 3 Severe: VF was defined as more than 40% reduction in any vertebral height. |
| Secondary | Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months | Baseline, 12 months | Worsening vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture) |
| Secondary | Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months | Baseline, Month 24 | Worsening vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture) |
| Secondary | Mean Change in Height From Baseline | from Baseline to 12 months and 24 months | Height was measured using a stadiometer. Two measurements were taken in millimeters (mm), and repeated if the two measurements differed by greater than 4 mm. The average of the two (or four) height measurements was used for analysis |
| Secondary | Number of Participants With First Clinical Vertebral Fracture | 24 months | Clinical vertebral fracture is a painful vertebral fracture which came to clinical attention, e.g., with increased back pain, impairment of mobility or functional limitations. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier. |
| Secondary | Number of Participants With First Clinical Fracture | 24 months | Clinical fracture is painful fracture in any site which came to clinical attention, e.g., with increased pain, impaired mobility or functional limitations. Subjects who did not experience fracture were censored at end of study. End of study was defined as the earlier of last visit or date of death. |
| Secondary | Number of Participants With First Non-vertebral Fracture | 24 months | Non-vertebral fracture is any fracture which was not of the vertebrae. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months | 24 Months | Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. In this analysis, missing Month 24 fractures were imputed using LOCF. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months | 12 Months | Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months | 12 months | Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months | 24 Months | Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months | Baseline, 12 months | Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months | Baseline, Month 24 | Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. In this analysis, missing Month 24 fractures were imputed using LOCF. | Percentage of Participants | NUMBER |
| SECONDARY | Mean Change in Height From Baseline | from Baseline to 12 months and 24 months | Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included. | mm | MEAN |
| SECONDARY | Number of Participants With First Clinical Vertebral Fracture | 24 months | The ITT (intent to treat) population consisted of all subjects as randomized. | Participants | NUMBER |
| SECONDARY | Number of Participants With First Clinical Fracture | 24 months | The ITT (intent to treat) population consisted of all subjects as randomized. | Participants | NUMBER |
| SECONDARY | Number of Participants With First Non-vertebral Fracture | 24 months | The ITT (intent to treat) population consisted of all subjects as randomized. | Participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months | Zoledronic Acid | 1.6 | Percentage of Participants | ||
| Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months | Placebo | 4.9 | Percentage of Participants | ||
| Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months | Zoledronic Acid | 0.9 | Percentage of participants | ||
| Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months | Placebo | 2.8 | Percentage of participants | ||
| Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months | Zoledronic Acid | 0.4 | Percentage of participants | ||
| Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months | Placebo | 1.9 | Percentage of participants | ||
| Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months | Zoledronic Acid | 1.1 | Percentage of participants | ||
| Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months | Placebo | 3.0 | Percentage of participants | ||
| Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months | Zoledronic Acid | 1.3 | Percentage of Participants | ||
| Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months | Placebo | 2.8 | Percentage of Participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zoledronic Acid | 588 | |
| Overall Study | STARTED | Placebo | 611 | |
| Overall Study | Modified Intent to Treat (mITT) | Zoledronic Acid | 553 | |
| Overall Study | Modified Intent to Treat (mITT) | Placebo | 574 | |
| Overall Study | COMPLETED | Zoledronic Acid | 530 | |
| Overall Study | COMPLETED | Placebo | 540 | |
| Overall Study | NOT COMPLETED | Zoledronic Acid | 58 | |
| Overall Study | NOT COMPLETED | Placebo | 71 |
Source ClinicalTrials.gov
Adverse events558
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 | Chills | General disorders | Zoledronic Acid | 40 | 588 | |
| other | Chills | General disorders | Placebo | 5 | 611 | |
| other | Fatigue | General disorders | Zoledronic Acid | 40 | 588 | |
| other | Fatigue | General disorders | Placebo | 13 | 611 | |
| other | Influenza like illness | General disorders | Zoledronic Acid | 30 | 588 | |
| other | Influenza like illness | General disorders | Placebo | 14 | 611 | |
| other | Pyrexia | General disorders | Zoledronic Acid | 143 | 588 | |
| other | Pyrexia | General disorders | Placebo | 21 | 611 | |
| other | Influenza | Infections and infestations | Zoledronic Acid | 30 | 588 | |
| other | Influenza | Infections and infestations | Placebo | 28 | 611 |
1 to 10 of 558Source ClinicalTrials.gov
See all 558 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zoledronic Acid | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Zoledronic Acid | 399 | 588 |
| Total, other adverse events | Placebo | 256 | 611 |
| Total, serious adverse events | Zoledronic Acid | 149 | 588 |
| Total, serious adverse events | Placebo | 154 | 611 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23113482 | 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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Zoledronic Acid vs Placebo: Number of Participants With First Clinical Vertebral Fracture | Trial comparisons |
| Zoledronic Acid vs Placebo: Number of Participants With First Clinical Fracture | Trial comparisons |
| Zoledronic Acid vs Placebo: Number of Participants With First Non-vertebral Fracture | Trial comparisons |
| Zoledronic Acid vs Placebo: serious adverse events | 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/NCT00439647
GET https://conductscience.org/api/trials/v1/NCT00439647/results?page=2