Trial · NCT04586660
Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone
NCT04586660, Phase 4, Active not recruiting, Amgen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone. Trials, record NCT04586660. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04586660
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone
- NCT number
- NCT04586660
- Status
- Active not recruiting
- Phases
- Phase 4
- Enrollment
- 36 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Giant Cell Tumor of Bone
- Interventions
- XGEVA®
- First posted
- 2020-10-14
- Last updated
- 2025-10-01
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective tumor response | Up to 36 months | Objective tumor response is defined as the percentage of participants with complete response (CR) or partial response (PR) evaluated based on European Organisation for Research and Treatment of Cancer (EORTC) criteria and Response Evaluation Criteria in Solid Tumors (RECIST). |
| Secondary | Time to disease progression or recurrence in participants with unsalvageable giant cell tumor of bone (GCTM) (Cohort 1 only) | From baseline until end of treatment, up to a maximum of 36 months | |
| Secondary | Number of participants with surgically salvageable giant cell tumor of bone (GCTB) after treatment (Cohort 1 only) | Month 36 | |
| Secondary | Time to disease progression or recurrence for participants with complete response (CR) from time of surgery (Cohort 2 only) | From time of surgery until end of treatment, up to a maximum of 36 months | |
| Secondary | Number of participants who do not require surgery in participants with salvageable giant cell tumor of bone (GCTB) (Cohort 2 only) | Up to 36 months | |
| Secondary | Number of participants with surgically downstaging in participants with salvageable giant cell tumor of bone (GCTB) (Cohort 2 only) | Up to 36 months | |
| Secondary | Change from baseline in bone turnover markers (urinary N-telopeptide [uNTX]/creatinine ratio) | Baseline to Month 36 | |
| Secondary | Change from baseline in severity of pain assessed by Brief Pain Inventory - Short Form (BPI-SF) score | Baseline to Month 36 | Pain severity will be assessed using Brief Pain Inventory - Short Form. The minimum score is 0 (no pain) and the maximum score is 10 (worst pain imaginable). The higher the score means a worse outcome of more pain. |
| Secondary | Number of participants who experience one or more treatment-emergent adverse events (TEAEs) | Baseline to end of safety follow-up, up to approximately 37 months | |
| Secondary | Number of participants who experience adverse events of special interest | Baseline to end of safety follow-up, up to approximately 37 months | Adverse events of special interest include hypocalcemia, hypercalcemia following investigational product discontinuation, atypical femoral fracture, and osteonecrosis of the jaw. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 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/NCT04586660
GET https://conductscience.org/api/trials/v1/NCT04586660/registered