Trial · NCT07471880
A Phase II Trial of RAB001 (LLP2A-Alendronate) for Steroid-Induced Early-Stage Osteonecrosis of the Femoral Head
NCT07471880, Phase 2, Active not recruiting, ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Trial of RAB001 (LLP2A-Alendronate) for Steroid-Induced Early-Stage Osteonecrosis of the Femoral Head. Trials, record NCT07471880. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07471880
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Trial of RAB001 (LLP2A-Alendronate) for Steroid-Induced Early-Stage Osteonecrosis of the Femoral Head
- NCT number
- NCT07471880
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 161 participants, actual
- Lead sponsor
- ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.
- Conditions
- Osteonecrosis, Osteonecrosis of the Femoral Head
- Interventions
- RAB001 high dose, RAB001 medium dose, RAB001 low dose, Alendronate (Fosamax)
- First posted
- 2026-03-13
- Last updated
- 2026-03-24
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Necrotic Area Volume of the Femoral Head (MRI) | week48 | |
| Primary | Changes in Hip Function Scores (HHS) | week48 | It is a clinical tool widely used to assess hip function and pain levels. The scoring system is administered by physicians through questionnaires and physical examinations, covering multiple dimensions such as pain, function, deformity, and range of motion.Higher scores indicate milder symptoms in patients, with a maximum of 100 points and a minimum of 0 points. |
| Secondary | Changes in the volume of the femoral head necrotic area (MRI) | week24 | |
| Secondary | Changes in Hip Function Scores (HHS) | week24 | It is a clinical tool widely used to assess hip function and pain levels. The scoring system is administered by physicians through questionnaires and physical examinations, covering multiple dimensions such as pain, function, deformity, and range of motion.Higher scores indicate milder symptoms in patients, with a maximum of 100 points and a minimum of 0 points. |
| Secondary | Changes in bone mineral density (DEXA) of the proximal femur (total hip) and lumbar spine (L1-L4) | week24and week48 | |
| Secondary | Rate of non-collapse of the femoral head(defined as femoral head collapse ≤ 2mm based on hip CT + MRI examination) | week24 and week48 | |
| Secondary | Time to progression of osteonecrosis in the target-side femoral head compared to baseline (defined as femoral head collapse > 2mm based on hip CT + MRI examination) | week48 | |
| Secondary | Changes in WOMAC scores | week24 and week48 | The WOMAC score is one of the most widely used tools in hip or knee osteoarthritis research and clinical practice. It comprises three subscales: Pain, Stiffness, and Physical Function. Lower scores indicate milder symptoms in patients, with the scale ranging from a minimum of 0% to a maximum of 100%. |
| Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | week 48 | |
| Secondary | Incidence of anti-drug antibodies (ADA) | week1、week7、week25、week49 week53 |
Source ClinicalTrials.gov
Outcomes0
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/NCT07471880
GET https://conductscience.org/api/trials/v1/NCT07471880/registered