Trial Outcomes & Findings for Losartan to Improve Hip Microfracture (NCT NCT04212650)
NCT ID: NCT04212650
Last Updated: 2023-10-30
Results Overview
Occurrence of treatment-emergent adverse events
TERMINATED
PHASE1/PHASE2
1 participants
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).
2023-10-30
Participant Flow
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.
Of 1 enrolled participant, 1 met inclusion criteria and was randomized to treatment.
Participant milestones
| Measure |
Losartan
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.
Losartan: 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.
|
Placebo
Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.
Placebo: Appearance-matched microcrystalline cellulose placebo
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Losartan
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.
Losartan: 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.
|
Placebo
Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.
Placebo: Appearance-matched microcrystalline cellulose placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Losartan to Improve Hip Microfracture
Baseline characteristics by cohort
| Measure |
Losartan
n=1 Participants
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.
Losartan: 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.
|
Placebo
Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.
Placebo: Appearance-matched microcrystalline cellulose placebo
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
—
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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).Population: There was 1 subject enrolled into the Losartan arm, but withdrew before any follow-up data was collected. One serious adverse event was reported 3 days post-enrollment. This AE was determined to be unrelated to the research or study drug and is reported in the AE section.
Occurrence of treatment-emergent adverse events
Outcome measures
| Measure |
Losartan
n=1 Participants
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.
Losartan: 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.
|
Placebo
Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.
Placebo: Appearance-matched microcrystalline cellulose placebo
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months and 18 monthsPopulation: Baseline SF-12 PCS Score was 48.8 for the 1 enrolled participant. Participant was randomized to Losartan arm but withdrew before any follow up data was collected.
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.
Outcome measures
| Measure |
Losartan
n=1 Participants
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.
Losartan: 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.
|
Placebo
Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.
Placebo: Appearance-matched microcrystalline cellulose placebo
|
|---|---|---|
|
Patient Reported Outcomes Questionnaire
|
48.8 score on a scale
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months and 18 monthsPopulation: Patient satisfaction is not collected at baseline. Participant was randomized to Losartan arm but withdrew before any follow up data was collected.
Patient Satisfaction * Scale from 1-10. * Higher score represents greater patient satisfaction.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months and 18 monthsPopulation: Baseline HHS Score was 57 for the 1 enrolled participant. Participant was randomized to Losartan arm but withdrew before any follow up data was collected.
Harris Hip Score (HHS). * Scale from 0-100. * Higher score represents greater hip health.
Outcome measures
| Measure |
Losartan
n=1 Participants
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.
Losartan: 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.
|
Placebo
Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.
Placebo: Appearance-matched microcrystalline cellulose placebo
|
|---|---|---|
|
Patient Reported Outcomes Questionnaire - Harris Hip Score
|
57 score on a scale
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months and 18 monthsPopulation: Baseline HOS-ADL Score was 68 for the 1 enrolled participant. Participant was randomized to Losartan arm but withdrew before any follow up data was collected.
Hip Outcome Score (HOS) - Including Sport and Activities of Daily Living (ADL) subscales. * Scale from 0-100. * Higher score represents greater hip health.
Outcome measures
| Measure |
Losartan
n=1 Participants
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.
Losartan: 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.
|
Placebo
Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.
Placebo: Appearance-matched microcrystalline cellulose placebo
|
|---|---|---|
|
Patient Reported Outcomes Questionnaire - Hip Outcome Score
|
68 score on a scale
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months and 18 monthsPopulation: Baseline WOMAC Total Score was 31 for the 1 enrolled participant. Participant was randomized to Losartan arm but withdrew before any follow up data was collected.
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.
Outcome measures
| Measure |
Losartan
n=1 Participants
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.
Losartan: 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.
|
Placebo
Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.
Placebo: Appearance-matched microcrystalline cellulose placebo
|
|---|---|---|
|
Patient Reported Outcomes Questionnaire - Western Ontario and McMaster Universities Osteoarthritis Index
|
31 score on a scale
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months and 18 monthsPopulation: Baseline Tegner Activity Scale was unavailable for the 1 enrolled participant. Participant was randomized to Losartan arm but withdrew before any follow up data was collected.
Tegner Activity Scale * Scale from 0-10. * Higher score represents greater activity level.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months and 18 monthsPopulation: Baseline NRS Pain Score was 6 for the 1 enrolled participant. Participant was randomized to Losartan arm but withdrew before any follow up data was collected.
Numeric Rating Scale (NRS) for Pain * Scale from 1-10. * Higher score represents greater pain.
Outcome measures
| Measure |
Losartan
n=1 Participants
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.
Losartan: 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.
|
Placebo
Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.
Placebo: Appearance-matched microcrystalline cellulose placebo
|
|---|---|---|
|
Patient Reported Outcomes Questionnaire - Numeric Rating Scale for Pain
|
6 score on a scale
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Participant was randomized to Losartan arm but withdrew before any follow up data was collected. Baseline quantitative MRI was not processed due to participant withdrawal and study closure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months, and 12 monthsPopulation: Participant was randomized to Losartan arm but withdrew before any follow up data was collected. Baseline hip strength assessment data was not compiled due to participant withdrawal and study closure.
Standard physical exam assessment of hip strength, measured in Newtons.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months, and 12 monthsPopulation: Participant was randomized to Losartan arm but withdrew before any follow up data was collected. Baseline hip range of motion assessment data was not compiled due to participant withdrawal and study closure.
Standard physical exam assessments of hip range of motion (ROM), measured in degrees.
Outcome measures
Outcome data not reported
Adverse Events
Losartan
Placebo
Serious adverse events
| Measure |
Losartan
n=1 participants at risk
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.
Losartan: 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.
|
Placebo
Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.
Placebo: Appearance-matched microcrystalline cellulose placebo
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain
|
100.0%
1/1 • Number of events 1 • 1 week
Participant was randomized to Losartan arm but withdrew before any follow up data was collected. Study closed.
|
—
0/0 • 1 week
Participant was randomized to Losartan arm but withdrew before any follow up data was collected. Study closed.
|
Other adverse events
Adverse event data not reported
Additional Information
Suzanne Liv Page, JD
Steadman Philippon Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place