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A Phase II Randomized Controlled Trial of RAB001 (LLP2A-Alendronate) for Steroid-Induced Early-Stage Osteonecrosis of the Femoral Head | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

A Phase II Randomized Controlled Trial of RAB001 (LLP2A-Alendronate) for Steroid-Induced Early-Stage Osteonecrosis of the Femoral Head

A Multicenter, Randomized, Controlled, Blinded, Phase II Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and PK/PD Profiles of RAB001 for Injection in Patients With Early-stage Non-traumatic Osteonecrosis Caused by Long-term Glucocorticoid Use.（LLP2A-Alendronate）

NCT07471880•ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized (similar to drawing lots, where the treatment you receive is not chosen by you or the researchers), controlled, blinded (the three dose groups of the investigational drug are blinded, meaning neither you nor the blinded researchers will know which dose you are receiving) clinical study to evaluate the efficacy, safety, and PK/PD profiles of RAB001 for injection in patients with early-stage non-traumatic osteonecrosis caused by long-term glucocorticoid use. A parallel-group enrollment design will be used, with a total of approximately 160 subjects expected to be enrolled (High-dose A: 1200 μg/kg；Medium-dose B: 750 μg/kg ；Low-dose C: 400 μg/kg): Control group (D: Alendronate Sodium Tablets (Fosamax) 70 mg orally once weekly) = 40 cases . If you agree to participate in this trial, you will have a 25% chance of being assigned to one of the groups mentioned above. Supportive treatment: Calcium (recommended dose: 1000-1200 mg/d) + Vitamin D (recommended dose: 600-800 IU/d). The study physician may choose the appropriate dosage of calcium and vitamin D based on the subject's specific conditions. Primary endpoints: 1. . Change in femoral head necrotic lesion volume at 48 weeks (MRI) 2. . Change in hip function score at 48 weeks (HHS, Harris Hip Score)

Eligibility

Age

18 - 69 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18 years ≤ age ≤ 69 years, gender not limited;
•Patients with glucocorticoid-induced osteonecrosis of the femoral head (ONFH) according to the 2019 edition of the "Guidelines for clinical diagnosis and treatment of osteonecrosis of the femoral head in adults", with an ARCO stage of II, and confirmed by CT and MRI examinations to have no femoral head collapse, and the time from first glucocorticoid use to the screening period must exceed 30 days;
•The participant has no plans for hip surgery on the target side within the next 54 weeks;
•Participants with unilateral or bilateral ONFH are not restricted. For unilateral involvement, the affected side (as the target side) must have no femoral head collapse confirmed by hip CT examination. For bilateral involvement, hip CT examination must confirm that at least one side has no collapse (the non-collapsed side is the target side; if both sides are necrotic and neither has collapsed, the side with more severe necrosis is the target side. If the contralateral side of the target side meets the criteria for study-defined osteonecrosis, all study information must be recorded for that side as for the target side);
•Participants must be informed about the study and voluntarily sign a written informed consent form before the trial.

Exclusion Criteria

•BMI ≥ 35 kg/m²;
•The target-side osteonecrosis of the femoral head (ONFH) is classified as type M according to the China-Japan Friendship Hospital (CJFH) classification;
•Inability to walk or to complete all the examinations, treatments, and follow-ups required by the trial protocol;
•Currently receiving glucocorticoid pulse therapy;
•Severe metabolic diseases, cardiovascular diseases, clinically significant atrial fibrillation, uncontrolled hypertension, uncontrolled asthma, symptomatic pulmonary fibrosis, recent gastrointestinal bleeding requiring transfusion, mental or psychological disorders;
•History of deep vein thrombosis, with any invasive preventive/therapeutic measures taken within the last five years;
•Current fracture or infection in either hip joint, or previous surgery on the target-side hip joint;
•Planned oral surgery within 54 weeks after enrollment;
•Known hereditary bone diseases, such as achondroplasia, osteogenesis imperfecta, hypophosphatemic rickets, etc.;
•Use of medications for bone metabolic diseases, integrins, α4β1 inhibitors/antagonists, or anti-VEGF drugs within 6 months or 5 half-lives (whichever is longer) prior to screening, as detailed in section 12.7;
+11 more criteria

Locations (1)

ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.

Zhongshan, Guangdong, China

Key Dates

Start Date

December 24, 2024

Primary Completion Date

October 10, 2026

Completion Date

February 28, 2027

Last Updated

March 13, 2026

Enrollment

161

ACTUAL participants

Conditions

OsteonecrosisOsteonecrosis of the Femoral Head

Interventions

RAB001 high dose

DRUG

RAB001 medium dose

DRUG

RAB001 low dose

DRUG

Alendronate (Fosamax)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase II Randomized Controlled Trial of RAB001 (LLP2A-Alendronate) for Steroid-Induced Early-Stage Osteonecrosis of the Femoral Head

Inclusion Criteria

Exclusion Criteria

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The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral Head

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