Active — Not RecruitingPhase 2

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

China161 participantsStarted 2024-12-24

Plain-language 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)

Who can participate

Age range18 Years – 69 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) classi…

What they're measuring

Changes in Necrotic Area Volume of the Femoral Head (MRI)

Timeframe: week48

Changes in Hip Function Scores (HHS)

Timeframe: week48

Trial details

NCT IDNCT07471880

SponsorZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-10-10