Trial · NCT00523341
Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis
NCT00523341, Phase 3, Completed, Amgen; results first posted 2016-07-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis. Trials, record NCT00523341. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00523341
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis
- NCT number
- NCT00523341
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,550 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Osteopenia, Osteoporosis
- Interventions
- Denosumab
- First posted
- 2007-08-31
- Last updated
- 2022-11-07
- Results first posted
- 2016-07-12
Source ClinicalTrials.gov
Registered outcomes48
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | 84 months | A serious adverse event (SAE) is defined as an adverse event that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is other significant medical hazard. Treatment-related adverse events includes only events for which the investigator indicated there was a reasonable possibility they may have been caused by study drug. The following were classified as adverse events of interest (events that are considered to be identified or potential risks of denosumab treatment): positively adjudicated osteonecrosis of the jaw, positively adjudicated atypical femoral fracture, hypocalcemia, adverse events potentially related to hypersensitivity, serious infection (including bacterial cellulitis), malignancy, cardiac disorders, vascular disorders, fracture healing complications, eczema, acute pancreatitis, and musculoskeletal pain. |
| Primary | Number of Participants With Laboratory Toxicities of Grade ≥ 3 | 84 months | Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 3 indicates severe toxicity and Grade 4 indicates life-threatening toxicity. |
| Primary | Number of Participants With Antibodies to Denosumab | Every 12 months through Month 84 | |
| Secondary | Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit | Baseline (of extension study) and months 12, 24, 36, 60 and 84 | Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. |
| Secondary | Percent Change From Baseline in Total Hip Bone Mineral Density by Visit | Baseline (of extension study) and months 12, 24, 36, 60 and 84 | Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. |
| Secondary | Percent Change From Baseline in Femoral Neck Bone Mineral Density by Visit | Baseline (of extension study) and months 12, 24, 36, 60 and 84 | Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. |
| Secondary | Percent Change From Baseline in 1/3 Radius Bone Mineral Density by Visit | Baseline (of extension study) and months 12, 24, 36, 60 and 84 | 1/3 radius bone mineral density was measured in a subset of participants by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. |
| Secondary | Percent Change From Study 20030216 Baseline in Lumbar Spine Bone Mineral Density by Visit | Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84 | Lumbar spine bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants. |
| Secondary | Percent Change From Study 20030216 Baseline in Total Hip BMD by Visit | Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84 | Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants. |
| Secondary | Percent Change From Study 20030216 Baseline in Femoral Neck BMD by Visit | Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84 | Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants. |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 registered outcomesOutcomes48
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 Adverse Events (AEs) | 84 months | All participants who received at least one dose of denosumab. | participants | NUMBER |
| PRIMARY | Number of Participants With Laboratory Toxicities of Grade ≥ 3 | 84 months | All participants who received at least 1 dose of denosumab | participants | NUMBER |
| PRIMARY | Number of Participants With Antibodies to Denosumab | Every 12 months through Month 84 | All participants who received at least 1 dose of denosumab | participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit | Baseline (of extension study) and months 12, 24, 36, 60 and 84 | Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Hip Bone Mineral Density by Visit | Baseline (of extension study) and months 12, 24, 36, 60 and 84 | Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Femoral Neck Bone Mineral Density by Visit | Baseline (of extension study) and months 12, 24, 36, 60 and 84 | Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in 1/3 Radius Bone Mineral Density by Visit | Baseline (of extension study) and months 12, 24, 36, 60 and 84 | Participants in the DXA substudy with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Study 20030216 Baseline in Lumbar Spine Bone Mineral Density by Visit | Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84 | Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Study 20030216 Baseline in Total Hip BMD by Visit | Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84 | Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Study 20030216 Baseline in Femoral Neck BMD by Visit | Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84 | Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point. | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 outcomesResults by group402
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 Adverse Events (AEs) | Placebo / Denosumab | Any adverse event (AE) | 2070 | participants | |
| Number of Participants With Adverse Events (AEs) | Denosumab / Denosumab | Any adverse event (AE) | 2173 | participants | |
| Number of Participants With Adverse Events (AEs) | Placebo / Denosumab | Serious adverse event | 945 | participants | |
| Number of Participants With Adverse Events (AEs) | Denosumab / Denosumab | Serious adverse event | 1014 | participants | |
| Number of Participants With Adverse Events (AEs) | Placebo / Denosumab | Fatal adverse event | 101 | participants | |
| Number of Participants With Adverse Events (AEs) | Denosumab / Denosumab | Fatal adverse event | 108 | participants | |
| Number of Participants With Adverse Events (AEs) | Placebo / Denosumab | AE leading to study discontinuation | 145 | participants | |
| Number of Participants With Adverse Events (AEs) | Denosumab / Denosumab | AE leading to study discontinuation | 173 | participants | |
| Number of Participants With Adverse Events (AEs) | Placebo / Denosumab | AE leading to discontinuation of denosumab | 184 | participants | |
| Number of Participants With Adverse Events (AEs) | Denosumab / Denosumab | AE leading to discontinuation of denosumab | 216 | participants |
1 to 10 of 402Source ClinicalTrials.gov
See all 402 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 / Denosumab | 2,207 | |
| Overall Study | STARTED | Denosumab / Denosumab | 2,343 | |
| Overall Study | Received Treatment | Placebo / Denosumab | 2,206 | |
| Overall Study | Received Treatment | Denosumab / Denosumab | 2,343 | |
| Overall Study | COMPLETED | Placebo / Denosumab | 1,283 | |
| Overall Study | COMPLETED | Denosumab / Denosumab | 1,343 | |
| Overall Study | NOT COMPLETED | Placebo / Denosumab | 924 | |
| Overall Study | NOT COMPLETED | Denosumab / Denosumab | 1,000 |
Source ClinicalTrials.gov
Adverse events1,956
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 | Anaemia | Blood and lymphatic system disorders | Placebo/ Denosumab 60 mg Q6M | 141 | 2,206 | |
| other | Anaemia | Blood and lymphatic system disorders | Denosumab/ Denosumab 60 mg Q6M | 168 | 2,343 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo/ Denosumab 60 mg Q6M | 138 | 2,206 | |
| other | Vertigo | Ear and labyrinth disorders | Denosumab/ Denosumab 60 mg Q6M | 140 | 2,343 | |
| other | Cataract | Eye disorders | Placebo/ Denosumab 60 mg Q6M | 319 | 2,206 | |
| other | Cataract | Eye disorders | Denosumab/ Denosumab 60 mg Q6M | 317 | 2,343 | |
| other | Constipation | Gastrointestinal disorders | Placebo/ Denosumab 60 mg Q6M | 141 | 2,206 | |
| other | Constipation | Gastrointestinal disorders | Denosumab/ Denosumab 60 mg Q6M | 118 | 2,343 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo/ Denosumab 60 mg Q6M | 139 | 2,206 | |
| other | Diarrhoea | Gastrointestinal disorders | Denosumab/ Denosumab 60 mg Q6M | 152 | 2,343 |
1 to 10 of 1,956Source ClinicalTrials.gov
See all 1,956 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo/ Denosumab 60 mg Q6M | ||
| Total, all-cause mortality | Denosumab/ Denosumab 60 mg Q6M | ||
| Total, other adverse events | Placebo/ Denosumab 60 mg Q6M | 1,809 | 2,206 |
| Total, other adverse events | Denosumab/ Denosumab 60 mg Q6M | 1,920 | 2,343 |
| Total, serious adverse events | Placebo/ Denosumab 60 mg Q6M | 945 | 2,206 |
| Total, serious adverse events | Denosumab/ Denosumab 60 mg Q6M | 1,014 | 2,343 |
Source ClinicalTrials.gov
Papers16
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 / Denosumab vs Placebo / Denosumab: Number of Participants With Antibodies to Denosumab | Trial comparisons |
| Denosumab / Denosumab vs Placebo / Denosumab: Number of Participants With New Vertebral Fractures | Trial comparisons |
| Denosumab / Denosumab vs Placebo / Denosumab: Number of Participants With Non-Vertebral Fractures | Trial comparisons |
| Denosumab/ Denosumab 60 mg Q6M vs Placebo/ Denosumab 60 mg Q6M: 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/NCT00523341
GET https://conductscience.org/api/trials/v1/NCT00523341/registered?page=2