Trial · NCT00145327
Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)
NCT00145327, Phase 3, Completed, Novartis; results first posted 2011-04-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis). Trials, record NCT00145327. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00145327
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)
- NCT number
- NCT00145327
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,456 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Osteoporosis
- Interventions
- Zoledronic Acid, Placebo
- First posted
- 2005-09-05
- Last updated
- 2011-06-28
- Results first posted
- 2011-04-20
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3 | Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72; end of extension study) | The primary efficacy variable was the percentage change in BMD of the femoral neck as measured by dual x-ray absorptiometry (DXA) at Year 6 relative to Year 3. It was derived as 100 \*(femoral neck BMD at Year 6 - femoral neck BMD at Year 3) / (femoral neck BMD at Year 3). |
| Secondary | Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP | Year 4.5 | The amount of serum n-terminal propeptide of type I collagen (P1NP) as determined by the central laboratory. |
| Secondary | Bone Resorption and Formation Biochemical Markers at Year 6: P1NP | Year 6 | The amount of serum P1NP as determined by the central laboratory |
| Secondary | Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3 | Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54) | The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 \* (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3). |
| Secondary | Percentage Change in BMD of Lumbar Spine at Year 6 Relative to Year 3 | Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 | The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 \* (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3). |
| Secondary | Percentage Change in BMD of Distal Radius at Year 4.5 Relative to Year 3 | Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54) | The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 \* (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3). |
| Secondary | Percentage Change in BMD of Distal Radius at Year 6 Relative to Year 3 | Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72) | The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 \* (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3). |
| Secondary | Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 4.5 Relative to Year 3 | Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54) | The percentage change in BMD as measured by DXA at 4.5 relative to Year 3. It was derived as 100 \* (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3). |
| Secondary | Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 6 Relative to Year 3 | Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72) | The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 \* (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3). |
| Secondary | Percentage of Patients With New and New/Worsening Morphometric Vertebral Fractures | Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 | Lateral vertebral x-rays were performed at the final core study visit and at Year 6 and read by a central expert reader at a central imaging laboratory to assess for new or new/worsening morphometric vertebral fracture. The percentage of patients with new morphometric vertebral fractures (observed for the first time) and patients with either new or worsening morphometric vertebral fractures was calculated. |
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 | Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3 | Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72; end of extension study) | Modified intent-to-treat (MITT) population. The MITT population included all patients in the ITT population who had DXA measurements of the femoral neck at Year 3 and Year 6. This was the primary population for primary efficacy parameter. | Percentage Change in BMD | MEAN |
| SECONDARY | Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP | Year 4.5 | Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 as determined by the analysis window. | ng/mL | MEAN |
| SECONDARY | Bone Resorption and Formation Biochemical Markers at Year 6: P1NP | Year 6 | Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The Number of patients analyzed = the number of patients with measurements in Year 6 as determined by the analysis window. | ng/mL | MEAN |
| SECONDARY | Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3 | Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54) | Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 and Year 3 as determined by the analysis window. | Percentage Change in BMD | MEAN |
| SECONDARY | Percentage Change in BMD of Lumbar Spine at Year 6 Relative to Year 3 | Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 | Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 and Year 3 as determined by the analysis window. | Percentage change in BMD | MEAN |
| SECONDARY | Percentage Change in BMD of Distal Radius at Year 4.5 Relative to Year 3 | Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54) | Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 and Year 3 as determined by the analysis window. | Percentage change in BMD | MEAN |
| SECONDARY | Percentage Change in BMD of Distal Radius at Year 6 Relative to Year 3 | Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72) | Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 and Year 3 as determined by the analysis window. | Percentage change in BMD | MEAN |
| SECONDARY | Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 4.5 Relative to Year 3 | Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54) | Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 and Year 3 as determined by the analysis window. | Percentage change in BMD | MEAN |
| SECONDARY | Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 6 Relative to Year 3 | Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72) | Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 and Year 3 as determined by the analysis window. | Percentage change in BMD | MEAN |
| SECONDARY | Percentage of Patients With New and New/Worsening Morphometric Vertebral Fractures | Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 | Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 as determined by the analysis window. | Percentage of patients | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3 | Zoledronic Acid 6 | 0.557 | Standard Error 0.2154 | Percentage Change in BMD | |
| Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3 | Zoledronic Acid 3 Placebo 3 | -0.493 | Standard Error 0.2249 | Percentage Change in BMD | |
| Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3 | Placebo 3 Zoledronic Acid 3 | 3.337 | Standard Error 0.2329 | Percentage Change in BMD | |
| Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP | Zoledronic Acid 6 | 18.842 | Standard Error 0.4325 | ng/mL | |
| Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP | Zoledronic Acid 3 Placebo 3 | 29.677 | Standard Error 0.6977 | ng/mL | |
| Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP | Placebo 3 Zoledronic Acid 3 | 17.256 | Standard Error 0.3743 | ng/mL | |
| Bone Resorption and Formation Biochemical Markers at Year 6: P1NP | Zoledronic Acid 6 | 27.356 | Standard Error 0.6340 | ng/mL | |
| Bone Resorption and Formation Biochemical Markers at Year 6: P1NP | Zoledronic Acid 3 Placebo 3 | 30.344 | Standard Error 0.6050 | ng/mL | |
| Bone Resorption and Formation Biochemical Markers at Year 6: P1NP | Placebo 3 Zoledronic Acid 3 | 25.926 | Standard Error 0.7765 | ng/mL | |
| Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3 | Zoledronic Acid 6 | 2.618 | Standard Error 0.384 | Percentage Change in BMD |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zoledronic Acid 6 | 616 | |
| Overall Study | STARTED | Zoledronic Acid 3 Placebo 3 | 617 | |
| Overall Study | STARTED | Placebo 3 Zoledronic Acid 3 | 1,223 | |
| Overall Study | COMPLETED | Zoledronic Acid 6 | 474 | |
| Overall Study | COMPLETED | Zoledronic Acid 3 Placebo 3 | 493 | |
| Overall Study | COMPLETED | Placebo 3 Zoledronic Acid 3 | 975 | |
| Overall Study | NOT COMPLETED | Zoledronic Acid 6 | 142 | |
| Overall Study | NOT COMPLETED | Zoledronic Acid 3 Placebo 3 | 124 | |
| Overall Study | NOT COMPLETED | Placebo 3 Zoledronic Acid 3 | 248 |
Source ClinicalTrials.gov
Adverse events1,515
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 | Cataract | Eye disorders | Zoledronic Acid 6 | 35 | 613 | |
| other | Cataract | Eye disorders | Zoledronic Acid 3 Placebo 3 | 43 | 616 | |
| other | Cataract | Eye disorders | Placebo 3 Zoledronic Acid 3 | 72 | 1,221 | |
| other | Diarrhoea | Gastrointestinal disorders | Zoledronic Acid 6 | 31 | 613 | |
| other | Diarrhoea | Gastrointestinal disorders | Zoledronic Acid 3 Placebo 3 | 32 | 616 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo 3 Zoledronic Acid 3 | 57 | 1,221 | |
| other | Nausea | Gastrointestinal disorders | Zoledronic Acid 6 | 20 | 613 | |
| other | Nausea | Gastrointestinal disorders | Zoledronic Acid 3 Placebo 3 | 26 | 616 | |
| other | Nausea | Gastrointestinal disorders | Placebo 3 Zoledronic Acid 3 | 94 | 1,221 | |
| other | Fatigue | General disorders | Zoledronic Acid 6 | 24 | 613 |
1 to 10 of 1,515Source ClinicalTrials.gov
See all 1,515 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zoledronic Acid 6 | ||
| Total, all-cause mortality | Zoledronic Acid 3 Placebo 3 | ||
| Total, all-cause mortality | Placebo 3 Zoledronic Acid 3 | ||
| Total, other adverse events | Zoledronic Acid 6 | 421 | 613 |
| Total, other adverse events | Zoledronic Acid 3 Placebo 3 | 427 | 616 |
| Total, other adverse events | Placebo 3 Zoledronic Acid 3 | 908 | 1,221 |
| Total, serious adverse events | Zoledronic Acid 6 | 191 | 613 |
| Total, serious adverse events | Zoledronic Acid 3 Placebo 3 | 168 | 616 |
| Total, serious adverse events | Placebo 3 Zoledronic Acid 3 | 297 | 1,221 |
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 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/NCT00145327
GET https://conductscience.org/api/trials/v1/NCT00145327/results?page=2