A Phase 1/2 interventional study of Losartan and Placebo in Hip Osteoarthritis, Hip Impingement Syndrome and Cartilage Damage, sponsored by Steadman Philippon Research Institute. Terminated at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-10-30.
Sponsored by Steadman Philippon Research Institute · Phase 1/2, Interventional, and Treatment
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.
This is a prospective, double-blind, placebo-controlled, randomized clinical trial that will be conducted at The Steadman Clinic and Steadman Philippon Research Institute.
Articular cartilage defects that extend full thickness to subchondral bone rarely heal without intervention. Some patients may not develop clinically significant problems from acute full-thickness chondral defects, but many eventually suffer from debilitating degenerative changes. Microfracture is the most commonly used first-line treatment technique for chondral lesions in the hip, however, this procedure's effectiveness is limited by the repair tissue being a hybrid of hyaline and fibrocartilage. We hypothesize that administration of a transforming growth factor beta 1 (TGF-β1) blocker, losartan (an approved hypertension drug, angiotensin II receptor antagonist) with microfracture will enhance articular cartilage repair as assessed on quantitative magnetic resonance imaging. We will also measure patient benefit through the recording of patient reported outcomes in the 18 months following surgery. The Division of Pulmonary, Allergy and Rheumatology Products within the Center for Drug Evaluation and Research at the Food and Drug Administration has granted an investigational new drug (IND) exemption to pursue this trial in accordance with 21 CFR 312.2(b).
628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.
This study's enrollment of 1 is below the median of 90 across 450 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Steadman Philippon Research Institute is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
Appearance-matched microcrystalline cellulose placebo
Incidence of Treatment-Emergent Adverse Events
Occurrence of treatment-emergent adverse events
Time frame: 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).
Patient Reported Outcomes Questionnaire
12-question Short-Form General Health Survey (SF-12) - Including Physical Component Summary (PCS) and Mental Component Summary (MCS). * Higher score represents greater health. * Scale standardized to a US Population mean of 50 and standard deviation of 10 points.
Time frame: Baseline, 3 months, 6 months, 12 months and 18 months
Patient Reported Outcomes Questionnaire - Patient Satisfaction
Patient Satisfaction * Scale from 1-10. * Higher score represents greater patient satisfaction.
Time frame: Baseline, 3 months, 6 months, 12 months and 18 months
Patient Reported Outcomes Questionnaire - Harris Hip Score
Harris Hip Score (HHS). * Scale from 0-100. * Higher score represents greater hip health.
Time frame: Baseline, 3 months, 6 months, 12 months and 18 months
Patient Reported Outcomes Questionnaire - Hip Outcome Score
Hip Outcome Score (HOS) - Including Sport and Activities of Daily Living (ADL) subscales. * Scale from 0-100. * Higher score represents greater hip health.
Time frame: Baseline, 3 months, 6 months, 12 months and 18 months
Patient Reported Outcomes Questionnaire - Western Ontario and McMaster Universities Osteoarthritis Index
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Including Pain, Stiffness and Physical Function subscales. * Scale from 0-96. * Higher score represents worse hip health.
Time frame: Baseline, 3 months, 6 months, 12 months and 18 months
Patient Reported Outcomes Questionnaire - Tegner Activity Scale
Tegner Activity Scale * Scale from 0-10. * Higher score represents greater activity level.
Time frame: Baseline, 3 months, 6 months, 12 months and 18 months
Patient Reported Outcomes Questionnaire - Numeric Rating Scale for Pain
Numeric Rating Scale (NRS) for Pain * Scale from 1-10. * Higher score represents greater pain.
Time frame: Baseline, 3 months, 6 months, 12 months and 18 months
Morphological and Quantitative Magnetic Resonance Imaging (MRI)
Cartilage quality assessed by blinded radiologist using morphological MRI. Quantitative MRI using T2 mapping images with texture analysis used to assess water content and collagen organization within the cartilage and surrounding tissue.
Time frame: Baseline and 12 months
Physical Examination of the Hip - Strength
Standard physical exam assessment of hip strength, measured in Newtons.
Time frame: Baseline, 3 months, and 12 months
Physical Examination of the Hip - Range of Motion
Standard physical exam assessments of hip range of motion (ROM), measured in degrees.
Time frame: Baseline, 3 months, and 12 months
Participants were recruited from The Steadman Clinic between March 2, 2020 and August 7, 2020. The first and last participant were enrolled on August 7, 2020.
| Milestone | Losartan | Placebo |
|---|---|---|
| Started | 1 | 0 |
| Completed | 0 | 0 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Occurrence of treatment-emergent adverse events
| participants | Losartan | Placebo |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 1 | — |
12-question Short-Form General Health Survey (SF-12) - Including Physical Component Summary (PCS) and Mental Component Summary (MCS). * Higher score represents greater health. * Scale standardized to a US Population mean of 50 and standard deviation of 10 points.
| score on a scale | Losartan | Placebo |
|---|---|---|
| Patient Reported Outcomes Questionnaire | 48.8 | — |
Patient Satisfaction * Scale from 1-10. * Higher score represents greater patient satisfaction.
No measurements were reported for this outcome.
Harris Hip Score (HHS). * Scale from 0-100. * Higher score represents greater hip health.
| score on a scale | Losartan | Placebo |
|---|---|---|
| Patient Reported Outcomes Questionnaire - Harris Hip Score | 57 | — |
Hip Outcome Score (HOS) - Including Sport and Activities of Daily Living (ADL) subscales. * Scale from 0-100. * Higher score represents greater hip health.
| score on a scale | Losartan | Placebo |
|---|---|---|
| Patient Reported Outcomes Questionnaire - Hip Outcome Score | 68 | — |
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Including Pain, Stiffness and Physical Function subscales. * Scale from 0-96. * Higher score represents worse hip health.
| score on a scale | Losartan | Placebo |
|---|---|---|
| Patient Reported Outcomes Questionnaire - Western Ontario and McMaster Universities Osteoarthritis Index | 31 | — |
Tegner Activity Scale * Scale from 0-10. * Higher score represents greater activity level.
No measurements were reported for this outcome.
Numeric Rating Scale (NRS) for Pain * Scale from 1-10. * Higher score represents greater pain.
| score on a scale | Losartan | Placebo |
|---|---|---|
| Patient Reported Outcomes Questionnaire - Numeric Rating Scale for Pain | 6 | — |
Cartilage quality assessed by blinded radiologist using morphological MRI. Quantitative MRI using T2 mapping images with texture analysis used to assess water content and collagen organization within the cartilage and surrounding tissue.
No measurements were reported for this outcome.
Standard physical exam assessment of hip strength, measured in Newtons.
No measurements were reported for this outcome.
Standard physical exam assessments of hip range of motion (ROM), measured in degrees.
No measurements were reported for this outcome.
Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Losartan | 0/1 (0%) | 1/1 (100%) | 0/1 (0%) |
| Placebo | — | — | — |
| Event | Losartan | Placebo |
|---|---|---|
| PainMusculoskeletal and connective tissue disorders | 1/1 | — |
One (1) participant was enrolled in the study and subsequently randomized to the Losartan arm.
| Age, Categorical(Participants) | Losartan | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 0 | 1 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Losartan | Placebo | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Losartan | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Losartan | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 0 | 1 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Losartan | Placebo | Total |
|---|---|---|---|
| United States | 1 | — | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Steadman Philippon Research Institute