Trial · NCT03301857
Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
NCT03301857, Phase 4, Completed, Amgen; results first posted 2024-05-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004. Trials, record NCT03301857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03301857
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
- NCT number
- NCT03301857
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 85 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Giant Cell Tumor of Bone
- Interventions
- Denosumab
- First posted
- 2017-10-04
- Last updated
- 2024-05-20
- Other registries' IDs
- eudract:2017-001758-32
- Results first posted
- 2024-05-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) | Up to approximately 5 years | EOIs assessed in the study were signs and symptoms of osteonecrosis of the jaw (ONJ), malignancy (including malignancy in GCTB), atypical femoral fracture (AFF), hypocalcemia, hypercalcemia after treatment discontinuation, pregnancy and lactation (if occurring during treatment or within 5 months of the last dose of denosumab). Hypocalcemia includes events that occurred after 30 days following the last dose of IP and includes TEAEs only. Other EOIs encompass all events from signing the informed consent to the end of the study (approximately 5 years). ONJ and AFF events were adjudicated by independent reviewers. |
| Secondary | Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) | Up to approximately 5 years | An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. An AE is considered as treatment-emergent if the AE occurs during the time period from the first dose of IP in this study through last dose of IP plus 30 days. TEAEs related to IP include only TEAEs for which the Investigator indicated there was a reasonable possibility they may have been caused by IP. AEs were graded (grade 3 \[severe or medically significant but not immediately life-threatening\], 4 \[life-threatening\], and 5 \[death related to the AE\]) using the Common Terminology Criteria for Adverse Events (CTCAE). |
| Secondary | Number of Participants With Disease Progression or Recurrence of GCTB | Up to approximately 5 years | Disease progression or recurrence is defined as the best post-baseline response of progressive disease (PD) without any post-baseline complete response (CR) /partial response (PR) /stable disease (SD) or a post-baseline response of PD following a post-baseline CR/PR/SD. PD is defined as the response of progressive disease, locally recurrent disease or distant recurrence. CR is defined as no evidence of disease following surgical resection while on study 20062004. PR is defined as no new lesion or disease progression while enrolled in study 20062004. SD is defined as local disease progression/recurrence or distant metastatic disease while on study 20062004. |
| Secondary | Number of Participants Receiving GCTB Interventions | Up to approximately 5 years | GCTB interventions include: surgery, chemotherapy, embolization, interferon, and radiotherapy. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) | Up to approximately 5 years | FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study. | Count of Participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) | Up to approximately 5 years | FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study. | Count of Participants | NUMBER |
| SECONDARY | Number of Participants With Disease Progression or Recurrence of GCTB | Up to approximately 5 years | FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study. The number of participants analyzed is inclusive of participants with available data. | Count of Participants | NUMBER |
| SECONDARY | Number of Participants Receiving GCTB Interventions | Up to approximately 5 years | FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study. | Count of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) | Exposed to IP | Adjudicated positive ONJ | 3 | Count of Participants | |
| Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) | Not Exposed to IP | Adjudicated positive ONJ | 0 | Count of Participants | |
| Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) | Exposed to IP | Malignancy, including malignancy in GCTB | 6 | Count of Participants | |
| Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) | Not Exposed to IP | Malignancy, including malignancy in GCTB | 1 | Count of Participants | |
| Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) | Exposed to IP | Adjudicated positive AFF | 2 | Count of Participants | |
| Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) | Not Exposed to IP | Adjudicated positive AFF | 0 | Count of Participants | |
| Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) | Exposed to IP | Hypocalcemia | 3 | Count of Participants | |
| Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) | Not Exposed to IP | Hypocalcemia | 0 | Count of Participants | |
| Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) | Exposed to IP | Hypocalcemia after treatment end | 0 | Count of Participants | |
| Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) | Not Exposed to IP | Hypocalcemia after treatment end | 0 | Count of Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Exposed to Investigational Product (IP) | 51 | |
| Overall Study | STARTED | Not Exposed to IP | 34 | |
| Overall Study | Received Denosumab | Exposed to Investigational Product (IP) | 51 | |
| Overall Study | Received Denosumab | Not Exposed to IP | 0 | |
| Overall Study | COMPLETED | Exposed to Investigational Product (IP) | 29 | |
| Overall Study | COMPLETED | Not Exposed to IP | 26 | |
| Overall Study | NOT COMPLETED | Exposed to Investigational Product (IP) | 22 | |
| Overall Study | NOT COMPLETED | Not Exposed to IP | 8 |
Source ClinicalTrials.gov
Adverse events54
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 | Exposed to IP | 4 | 51 | |
| other | Anaemia | Blood and lymphatic system disorders | Not Exposed to IP | 0 | 34 | |
| other | Toothache | Gastrointestinal disorders | Exposed to IP | 8 | 51 | |
| other | Toothache | Gastrointestinal disorders | Not Exposed to IP | 0 | 34 | |
| other | Pyrexia | General disorders | Exposed to IP | 3 | 51 | |
| other | Pyrexia | General disorders | Not Exposed to IP | 0 | 34 | |
| other | COVID-19 | Infections and infestations | Exposed to IP | 7 | 51 | |
| other | COVID-19 | Infections and infestations | Not Exposed to IP | 0 | 34 | |
| other | Gingivitis | Infections and infestations | Exposed to IP | 3 | 51 | |
| other | Gingivitis | Infections and infestations | Not Exposed to IP | 0 | 34 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Exposed to IP | 0 | 51 |
| Total, all-cause mortality | Not Exposed to IP | 2 | 34 |
| Total, other adverse events | Exposed to IP | 37 | 51 |
| Total, other adverse events | Not Exposed to IP | 0 | 34 |
| Total, serious adverse events | Exposed to IP | 8 | 51 |
| Total, serious adverse events | Not Exposed to IP | 0 | 34 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Exposed to IP vs Not Exposed to IP: deaths from any cause | Trial comparisons |
| Exposed to IP vs Not Exposed to IP: 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/NCT03301857
GET https://conductscience.org/api/trials/v1/NCT03301857/results?page=2