Losartan to Improve Hip Microfracture

NCT04212650 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 2019-15
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I/IIA randomized, double-blind, placebo-controlled clinical trial to assess safety and efficacy of oral losartan for improving cartilage repair following microfracture to treat focal cartilage defects during hip arthroscopy.

Conditions

Hip Osteoarthritis; Hip Impingement Syndrome; Cartilage Damage; Fibrosis

Keywords

Cartilage Microfracture; Losartan; Transforming growth factor beta 1; Hip Arthroscopy

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Occurrence of treatment-emergent adverse events

  Drug related adverse events will be monitored during the medication phase (post-op days 2-31) and orthopaedic-related health and function will be monitored for the entire study duration (18 months).

Secondary Outcomes (10)

• Patient Reported Outcomes Questionnaire

  Baseline, 3 months, 6 months, 12 months and 18 months

• Patient Reported Outcomes Questionnaire - Patient Satisfaction

  Baseline, 3 months, 6 months, 12 months and 18 months

• Patient Reported Outcomes Questionnaire - Harris Hip Score

  Baseline, 3 months, 6 months, 12 months and 18 months

• Patient Reported Outcomes Questionnaire - Hip Outcome Score

  Baseline, 3 months, 6 months, 12 months and 18 months

• Patient Reported Outcomes Questionnaire - Western Ontario and McMaster Universities Osteoarthritis Index

  Baseline, 3 months, 6 months, 12 months and 18 months

Study Arms (2)

Losartan

EXPERIMENTAL

12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.

Drug: Losartan

Placebo

PLACEBO COMPARATOR

Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.

Other: Placebo

Interventions

Losartan DRUG

Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.

Also known as: Losartan Potassium

Losartan

Placebo OTHER

Appearance-matched microcrystalline cellulose placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Underwent primary hip arthroscopy
• Underwent baseline quantitative MRI at The Steadman Clinic (TSC)
• Single, localized, grade 3 or 4 cartilage lesion of the acetabulum or femoral head treated with Bone Marrow Stimulation (BMS; i.e. microfracture)
• Aged 18-60 at time of surgery
• Tonnis grade 1 or less

You may not qualify if:

• Two or more cartilage lesions of grade 3 or 4
• Less than 2 mm of minimal hip joint space
• Osteoarthritis or diffuse change of cartilage
• Non-English speaking
• Prior hip surgery on operative hip
• Pre-existing bony deformity caused by previous fracture(s)
• Synovial chondromatosis
• Pigmented Villonodular Synovitis (PVNS)
• Dysplasia (center edge angle \<20 degrees)
• History of Avascular Necrosis (AVN), Perthes disease, or slipped capital femoral epiphysis (SCFE)
• Inflammatory arthritis or other arthritis caused by autoimmune disease
• Patients allergic to any active or inactive ingredient of losartan
• Patients taking medication with known losartan interaction, including phenobarbital, rifampin, and fluconazole.
• Subjects that are currently taking losartan

Sponsors & Collaborators

• Steadman Philippon Research Institute: lead
• United States Department of Defense: collaborator
• Office of Naval Research (ONR): collaborator

Study Sites (1)

Steadman Philippon Research Institute

Vail, Colorado, 81657, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Fibrosis; Camurati-Engelmann Syndrome

Interventions

Losartan

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Limitations and Caveats

Per opinion of the Principal Investigator, Losartan is now clinically indicated as a standard of care post-operative therapy for patients undergoing hip microfracture surgeries. The study was terminated early, resulting in a singular subject enrolled for data analysis. The subject elected to withdraw from the study prior to the first follow-up data collection timepoint.

Results Point of Contact

• Title: Suzanne Liv Page, JD
• Organization: Steadman Philippon Research Institute

spage@sprivail.org

970-401-8770

Study Officials

• Marc J Philippon, MD

  Steadman Philippon Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Block Randomization

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 27, 2019
• Study Start: August 7, 2020
• Primary Completion: December 4, 2020
• Study Completion: December 4, 2020
• Last Updated: October 30, 2023
• Results First Posted: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)