Summary
Cholesterol has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Osteoarthritis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Osteoarthritis. ClinicalTrials.gov lists 4 registered trials linking Cholesterol to Osteoarthritis: 1 is currently recruiting; 2 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00251069). The largest enrolment is 85 participants (NCT05749601). Registration activity spans 2005 to 2022. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 1 meta-analysis, 1 systematic review, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2010 to 2025. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Osteoarthritis ranks 302 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Structural progression is essentially universal over 10+ years without intervention; pain fluctuates but functional decline is the expected trajectory; no disease-modifying therapy exists as of 2024.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 60.5 (trials 10.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 4 total: 1 recruiting, 0 active / not yet recruiting, 2 completed, 1 other |
| Linked publications | 14 (5 Cochrane reviews, 5 clinical trial publications, 2 randomised controlled trial publications, 1 meta-analysis, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | APOE |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00251069 | Glucosamine Sulphate and Increased Level of Blood Cholesterol 2005 | completed | Phase 4 | 66 |
| NCT05749601 | Risk Factor Involved in Knee Osteoarthritis (KOA) 2022 | completed | Not applicable | 85 |
| NCT04210284 | Oral Nutritional Optimization in Total Joint Arthroplasty 2021 | recruiting | Not applicable | 72 |
| NCT01279395 | Anti-inflammatory Agents and Cholesterol Metabolism 2010 | terminated | Not applicable | 3 |
Published literature
- Clinical trial publication Bifidobacterium animalis subsp. lactis Probio-M8 enhances chondroitin efficacy for knee osteoarthritis in postmenopausal women via the gut-joint axisWang K, Wang H, Zhao Z et al. · mSystems · 2025 · PMID 41313018
- Clinical trial publication Risk factors for severe knee osteoarthritis and efficacy of diacerein in obese vietnamese patients: A randomized, single-blind, noncontrolled clinical trialPhan MH, Huynh TC, La VP et al. · Medicine · 2025 · PMID 41261710
- Clinical trial publication Efficacy and safety of low-dose rosuvastatin/ezetimibe for dyslipidemia in patients with rheumatoid arthritis or osteoarthritisBak SH, Lee KA, Kim SS et al. · Medicine · 2025 · PMID 40631878
- Cochrane review Coffee and health outcomes: a systematic review of Mendelian randomisation studiesPham K, Kassaw NA, Mulugeta A et al. · Nutrition research reviews · 2025 · PMID 41069178
- Cochrane review The relationship between circulating and tissue biomarkers and OA-related pain: A systematic literature reviewMathieu S, Kuhi L, Binvignat M et al. · Osteoarthritis and cartilage open · 2025 · PMID 41050371
- Clinical trial publication The effect of pentosan polysulfate sodium for improving dyslipidaemia and knee pain in people with knee osteoarthritis: A pilot studyLiu X, Virk S, Fedorova T et al. · Osteoarthritis and cartilage open · 2023 · PMID 36879559
- Meta-analysis Serum Metabolome Analysis Identified Amino-Acid Metabolism Associated With Pain in People With Symptomatic Knee Osteoarthritis - A Cross-Sectional StudyMehta O, Vijay A, Gohir SA et al. · The journal of pain · 2023 · PMID 36863678
- Clinical trial publication Effects of Diet Control and Telemedicine-Based Resistance Exercise Intervention on Patients with Obesity and Knee Osteoarthritis: A Randomized Control TrialHsu YI, Chen YC, Lee CL et al. · International journal of environmental research and public health · 2021 · PMID 34360036
- Randomized controlled trial The effect of L-Carnitine supplementation on clinical symptoms, C-reactive protein and malondialdehyde in obese women with knee osteoarthritis: a double blind randomized controlled trialBaghban F, Hosseinzadeh M, Mozaffari-Khosravi H et al. · BMC musculoskeletal disorders · 2021 · PMID 33596883
- Cochrane review Pine bark (Pinus spp.) extract for treating chronic disordersRobertson NU, Schoonees A, Brand A et al. · The Cochrane database of systematic reviews · 2020 · PMID 32990945
- Randomized controlled trial Effect of Two Meal Replacement strategies on Cardiovascular Risk Parameters in Advanced Age Patients with Obesity and OsteoarthritisLópez-Gómez JJ, Izaola-Jauregui O, Primo-Martín D et al. · Nutrients · 2020 · PMID 32244696
- Systematic review An update on the association between metabolic syndrome and osteoarthritis and on the potential role of leptin in osteoarthritisGao YH, Zhao CW, Liu B et al. · Cytokine · 2020 · PMID 32078923
- Cochrane review Cardiovascular profile in osteoarthritis: a meta-analysis of cardiovascular events and risk factorsMathieu S, Couderc M, Tournadre A et al. · Joint bone spine · 2019 · PMID 31323333
- Cochrane review Interventions to achieve long-term weight loss in obese older people: a systematic review and meta-analysisWitham MD, Avenell A · Age and ageing · 2010 · PMID 20083615
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target APOE. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Cholesterol approved for Osteoarthritis?
Cholesterol has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Osteoarthritis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Osteoarthritis. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Cholesterol in clinical trials for Osteoarthritis?
ClinicalTrials.gov lists 4 registered trials linking Cholesterol to Osteoarthritis: 1 is currently recruiting; 2 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00251069). The largest enrolment is 85 participants (NCT05749601). Registration activity spans 2005 to 2022.
What does the evidence show for Cholesterol in Osteoarthritis?
Cholesterol has both completed registered trials and synthesis-level publications linked to Osteoarthritis. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target APOE. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.