Trial · NCT00089674
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
NCT00089674, Phase 3, Completed, Amgen; results first posted 2014-06-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer. Trials, record NCT00089674. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00089674
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
- NCT number
- NCT00089674
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,468 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Prostate Cancer
- Interventions
- AMG 162, Placebo
- First posted
- 2004-08-11
- Last updated
- 2018-10-17
- Results first posted
- 2014-06-03
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 | 24 months | Lumbar Spine Bone Mineral Density Percent Chnage From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry. |
| Secondary | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 | 24 months | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry. |
| Secondary | Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 | 24 months | Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry. |
| Secondary | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 | 36 months | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry. |
| Secondary | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 | 36 months | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry. |
| Secondary | Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 | 36 months | Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry. |
| Secondary | Number of Participants With Any Fracture Through Month 36 | 36 months | Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges. |
| Secondary | Number of Participants With a New Vertebral Fracture Through Month 36 | 36 months | New Vertebral Fracture Assessed by Lateral Spine X-ray using Genant Semiquantitative Scoring Method excluding any symptomatic new vertebral fracture associated with high trauma severity or a pathologic fracture. |
| Secondary | Time to First Clinical Fracture Through Month 36 | 36 months | A clinical fracture was defined as any nonvertebral fracture or clinically evident fracture at the cervical vertebrae, thoracic vertebrae, and lumbar vertebrae that was associated with signs and/or symptoms indicative of a fracture. Fractures associated with high trauma severity and pathologic (ie, metastatic) fractures were excluded. Since the median time was not reached, time to first clinical fracture is represented by the Kaplan-Meier estimate of the percentage of participants with a clinical fracture. |
| Secondary | Number of Participants With Any Fracture Through Month 24 | 24 months | Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 | 24 months | Randomized subjects who had a nonmissing baseline and \>= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method. | Percent Change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 | 24 months | Randomized subjects who had a nonmissing baseline and \>= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method. | Percent Change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 | 24 months | Randomized subjects who had a nonmissing baseline and \>= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method. | Percent Change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 | 36 months | Randomized subjects who had a nonmissing baseline and \>= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method. | Percent Change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 | 36 months | Randomized subjects who had a nonmissing baseline and \>= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method. | Percent Change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 | 36 months | Randomized subjects who had a nonmissing baseline and \>= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method. | Percent Change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Any Fracture Through Month 36 | 36 months | Full analysis set | Participants | NUMBER |
| SECONDARY | Number of Participants With a New Vertebral Fracture Through Month 36 | 36 months | All randomized subjects who have a baseline and \>= 1 postbaseline evaluation of vertebral fracture at or before 3 years. | Participants | NUMBER |
| SECONDARY | Time to First Clinical Fracture Through Month 36 | 36 months | Full analysis set | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Any Fracture Through Month 24 | 24 months | Full analysis set | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 | Placebo | -1 | 95% Confidence Interval -1.4 to -0.7 | Percent Change from Baseline | |
| Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 | Denosumab 60 mg Q6M | 5.6 | 95% Confidence Interval 5.3 to 5.9 | Percent Change from Baseline | |
| Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 | Placebo | -1.5 | 95% Confidence Interval -1.8 to -1.1 | Percent Change from Baseline | |
| Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 | Denosumab 60 mg Q6M | 2.4 | 95% Confidence Interval 2.1 to 2.8 | Percent Change from Baseline | |
| Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 | Placebo | -2 | 95% Confidence Interval -2.3 to -1.8 | Percent Change from Baseline | |
| Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 | Denosumab 60 mg Q6M | 2.7 | 95% Confidence Interval 2.5 to 3.0 | Percent Change from Baseline | |
| Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 | Placebo | -1.2 | 95% Confidence Interval -1.5 to -0.8 | Percent Change from Baseline | |
| Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 | Denosumab 60 mg Q6M | 6.8 | 95% Confidence Interval 6.4 to 7.1 | Percent Change from Baseline | |
| Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 | Placebo | -1.8 | 95% Confidence Interval -2.2 to -1.5 | Percent Change from Baseline | |
| Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 | Denosumab 60 mg Q6M | 3 | 95% Confidence Interval 2.7 to 3.4 | Percent Change from Baseline |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 734 | |
| Overall Study | STARTED | Denosumab 60 mg Q6M | 734 | |
| Overall Study | Received Study Drug | Placebo | 730 | |
| Overall Study | Received Study Drug | Denosumab 60 mg Q6M | 726 | |
| Overall Study | COMPLETED | Placebo | 445 | |
| Overall Study | COMPLETED | Denosumab 60 mg Q6M | 467 | |
| Overall Study | NOT COMPLETED | Placebo | 289 | |
| Overall Study | NOT COMPLETED | Denosumab 60 mg Q6M | 267 |
Source ClinicalTrials.gov
Adverse events790
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 | Constipation | Gastrointestinal disorders | Placebo | 74 | 725 | |
| other | Constipation | Gastrointestinal disorders | Denosumab 60 mg Q6M | 73 | 731 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 39 | 725 | |
| other | Diarrhoea | Gastrointestinal disorders | Denosumab 60 mg Q6M | 39 | 731 | |
| other | Fatigue | General disorders | Placebo | 45 | 725 | |
| other | Fatigue | General disorders | Denosumab 60 mg Q6M | 44 | 731 | |
| other | Oedema peripheral | General disorders | Placebo | 47 | 725 | |
| other | Oedema peripheral | General disorders | Denosumab 60 mg Q6M | 52 | 731 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 45 | 725 | |
| other | Nasopharyngitis | Infections and infestations | Denosumab 60 mg Q6M | 47 | 731 |
1 to 10 of 790Source ClinicalTrials.gov
See all 790 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 | 364 | 725 |
| Total, other adverse events | Denosumab 60 mg Q6M | 390 | 731 |
| Total, serious adverse events | Placebo | 222 | 725 |
| Total, serious adverse events | Denosumab 60 mg Q6M | 253 | 731 |
Source ClinicalTrials.gov
Papers5
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 a New Vertebral Fracture Through Month 36 | Trial comparisons |
| Denosumab 60 mg Q6M vs Placebo: Number of Participants With Any Fracture Through Month 36 | Trial comparisons |
| Denosumab 60 mg Q6M vs Placebo: Number of Participants With Any Fracture Through Month 24 | 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/NCT00089674
GET https://conductscience.org/api/trials/v1/NCT00089674/events?page=2