Trial · NCT00089791
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
NCT00089791, Phase 3, Completed, Amgen; results first posted 2014-01-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis. Trials, record NCT00089791. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00089791
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
- NCT number
- NCT00089791
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7,808 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Osteoporosis
- Interventions
- placebo, Denosumab
- First posted
- 2004-08-16
- Last updated
- 2022-11-08
- Results first posted
- 2014-01-10
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With New Vertebral Fractures | 36 months | A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the Baseline grade of 0 in any vertebra from T4 to L4. New vertebral fractures included morphometric vertebral fractures (assessed at scheduled visits and not associated with signs or symptoms \[or both\] indicative of a fracture) and clinical vertebral fractures (assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms indicative of a fracture, excluding any fracture associated with high trauma severity or a pathologic fracture). |
| Secondary | Number of Participants With Nonvertebral Fractures | 36 months | Nonvertebral fractures (osteoporotic) were those occurring on study excluding those of the vertebrae (cervical, thoracic, and lumbar), skull, facial, mandible, metacarpus, finger phalanges, and toe phalanges. Fractures associated with high trauma severity (fractures that were the result of a fall from higher than the height of a stool, chair, first rung on a ladder or equivalent (\> 20 inches) or was the result of severe trauma other than a fall) and pathologic fractures were excluded from this category. Nonvertebral fractures were required to be confirmed either by radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI), or by documentation in a radiology report, surgical report, or discharge summary. |
| Secondary | Number of Participants With a Hip Fracture | 36 months | Hip fractures are a subset of nonvertebral fractures including femur neck, femur intertrochanter, and femur subtrochanter. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With New Vertebral Fractures | 36 months | Primary Efficacy Analysis Set, which includes all randomized participants who have a baseline and ≥ 1 postbaseline evaluation of vertebral fracture at or before 3 years. Last Observation Carried Forward was used. | Participants | NUMBER |
| SECONDARY | Number of Participants With Nonvertebral Fractures | 36 months | Full analysis set (all randomized participants) | Participants | NUMBER |
| SECONDARY | Number of Participants With a Hip Fracture | 36 months | Full analysis set | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With New Vertebral Fractures | Placebo | 264 | Participants | ||
| Number of Participants With New Vertebral Fractures | Denosumab 60 mg Q6M | 86 | Participants | ||
| Number of Participants With Nonvertebral Fractures | Placebo | 293 | Participants | ||
| Number of Participants With Nonvertebral Fractures | Denosumab 60 mg Q6M | 238 | Participants | ||
| Number of Participants With a Hip Fracture | Placebo | 43 | Participants | ||
| Number of Participants With a Hip Fracture | Denosumab 60 mg Q6M | 26 | Participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 3,906 | |
| Overall Study | STARTED | Denosumab 60 mg Q6M | 3,902 | |
| Overall Study | Received Study Medication | Placebo | 3,883 | |
| Overall Study | Received Study Medication | Denosumab 60 mg Q6M | 3,879 | |
| Overall Study | Safety Analysis Set | Placebo | 3,876 | |
| Overall Study | Safety Analysis Set | Denosumab 60 mg Q6M | 3,886 | |
| Overall Study | COMPLETED | Placebo | 3,206 | |
| Overall Study | COMPLETED | Denosumab 60 mg Q6M | 3,272 | |
| Overall Study | NOT COMPLETED | Placebo | 700 | |
| Overall Study | NOT COMPLETED | Denosumab 60 mg Q6M | 630 |
Source ClinicalTrials.gov
Adverse events1,786
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 | Placebo | 230 | 3,876 | |
| other | Cataract | Eye disorders | Denosumab 60 mg Q6M | 216 | 3,886 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 356 | 3,876 | |
| other | Constipation | Gastrointestinal disorders | Denosumab 60 mg Q6M | 351 | 3,886 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 231 | 3,876 | |
| other | Diarrhoea | Gastrointestinal disorders | Denosumab 60 mg Q6M | 224 | 3,886 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 209 | 3,876 | |
| other | Dyspepsia | Gastrointestinal disorders | Denosumab 60 mg Q6M | 175 | 3,886 | |
| other | Bronchitis | Infections and infestations | Placebo | 298 | 3,876 | |
| other | Bronchitis | Infections and infestations | Denosumab 60 mg Q6M | 297 | 3,886 |
1 to 10 of 1,786Source ClinicalTrials.gov
See all 1,786 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Denosumab 60 mg Q6M | ||
| Total, other adverse events | Placebo | 3,107 | 3,876 |
| Total, other adverse events | Denosumab 60 mg Q6M | 3,073 | 3,886 |
| Total, serious adverse events | Placebo | 972 | 3,876 |
| Total, serious adverse events | Denosumab 60 mg Q6M | 1,004 | 3,886 |
Source ClinicalTrials.gov
Papers32
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Denosumab 60 mg Q6M vs Placebo: Number of Participants With Nonvertebral Fractures | Trial comparisons |
| Denosumab 60 mg Q6M vs Placebo: Number of Participants With a Hip Fracture | Trial comparisons |
| Denosumab 60 mg Q6M vs Placebo: Number of Participants With New Vertebral Fractures | Trial comparisons |
| Denosumab 60 mg Q6M 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/NCT00089791
GET https://conductscience.org/api/trials/v1/NCT00089791/events?page=2