Trial · NCT05638399
Denosumab vs Zoledronate After Lumbar Fusion
NCT05638399, Phase 3, Unknown, Shenzhen People's Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Denosumab vs Zoledronate After Lumbar Fusion. Trials, record NCT05638399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05638399
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Denosumab vs Zoledronate After Lumbar Fusion
- NCT number
- NCT05638399
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Shenzhen People's Hospital
- Conditions
- Osteopenia, Lumbar Spondylolisthesis
- Interventions
- Denosumab 60 mg/ml [Prolia], Zoledronate
- First posted
- 2022-12-06
- Last updated
- 2023-02-21
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Lumbar bone mineral density(BMD) | up to 12 months | Lumbar vertebral (L1 to L4, except the surgery segment) BMD were determined at baseline, 6 and 12 months via dual energy X-ray |
| Primary | Total hip BMD | up to 12 months | Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray |
| Primary | Femoral neck BMD | up to 12 months | Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray |
| Primary | Procollagen type 1 n-terminal propeptide (P1NP) | up to 12 months | Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery |
| Primary | C-terminal cross-linked type 1 collagen terminal peptide (CTX) | up to 12 months | Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery |
| Primary | Visual analog scale (VAS) back | up to 12 months | The VAS score for back pain were determined at baseline, 6 and 12 month. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain. |
| Secondary | The Roland-Morris Disability Questionnaire | up to 12 month | The Roland-Morris Disability Questionnaire is scored by 24 adding up the number of items checked "yes" on different low back pain-related daily activity disabilities. Total scores range from 0 to 24, with higher scores 24 indicating a higher level of disability related to low back pain and lowest 0 represents no back pain. |
| Secondary | The QUALEFFO-31 Questionnaire | up to 12 month | The Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31), which contains three domains including pain, physical function, and mental function. This scale is assessed on a scale of 0 to 100, with 0 indicating the highest QoL and 100 the lowest. |
| Secondary | The EQ-5D Questionnaire | up to 12 month | The EuroQol five-dimension (EQ-5D) questionnaire evaluates health status consisting five dimensions: mobility, selfcare, performance of usual activities, pain or discomfort, and anxiety or depression. After conversion, the index was between 0 and 1.0 (minimum score: 0, indicating worst health state; full score:1.0, indicating full health). |
| Secondary | New fracture rate | up to 12 month | New fracture rate containing vertebral fracture and non-vertebral fracture was assessed at 12 month after surgery. The lowest score was 0, the highest score was 100%. The lower score 0 represents no secondary fracture. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT05638399
GET https://conductscience.org/api/trials/v1/NCT05638399/registered