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The Effect of Spironolactone on Pain in Older People With Osteoarthritis (SPIR-OA)

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

spironolactone

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis of knee

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participant is willing and able to give informed consent
Community dwelling
Aged 70 years and over
Symptomatic idiopathic OA knee according to American College of Rheumatology clinical and radiographic criteria (ie Knee pain - with or without crepitus and presence of osteophytes on x ray)
To avoid floor effects, participants will require to have moderate (or more severe) pain at screening in at least 2 out of 5 WOMAC pain score items
To have been in receipt (prescription or/and over the counter) of one or more analgesic agents at a therapeutic dose for at least 2 months
Willing to have knee x-ray if one has not been taken in preceding 12 months

Exclusion Criteria:

Clinical diagnosis of symptomatic heart failure
History of inflammatory arthritis
Already taking spironolactone
Previous intolerance to spironolactone
Known allergies to spironolactone or lactose
Objection to taking capsules made from animal sourced gelatine
Taking oral NSAIDs (because of the increased risk of renal impairment when combined with spironolactone)
Taking ACE inhibitors or ARBs (angiotensin II receptor antagonists). ARBs have many properties similar to those of ACE inhibitors. Both will be exclusion because of the increased risk of acute kidney injury and hyperkalaemia, and because our previous study also excluded those on ACE inhibitors (and ARBs) and treatment was safe and well tolerated.
Supine hypotension (supine systolic blood pressure <100mmHg at screening)
Significant chronic kidney disease (eGFR<40ml/min)
Serum sodium<130mmol/l
Serum potassium>5.0mmol/l
Symptomatic orthostatic hypotension (measured at screening)
Nursing home resident
Wheelchair bound
Participating in another clinical trial (other than observational trials and registries) concurrently or within 30 days prior to screening for entry into this study
Known contraindication to spironolactone therapy
Participant who is terminally ill, defined as less than 3 months expected survival

Sites / Locations

NHS Fife
NHS Tayside

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

spironolactone

Placebo

Arm Description

25mg spironolactone daily

Matched Placebo

Outcomes

Primary Outcome Measures

Between group difference in change in WOMAC pain subscale (5 items)

Secondary Outcome Measures

Between group difference in change in WOMAC stiffness subscale.

Full Information

NCT ID

NCT02046668

First Posted

January 24, 2014

Last Updated

October 11, 2019

Sponsor

University of Dundee

Collaborators

Arthritis Research UK

1. Study Identification

Unique Protocol Identification Number

NCT02046668

Brief Title

The Effect of Spironolactone on Pain in Older People With Osteoarthritis

Acronym

SPIR-OA

Official Title

A Randomised Placebo Controlled Trial. The Effect of Spironolactone on Pain in Older People With Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Dundee

Collaborators

Arthritis Research UK

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This pilot study will obtain preliminary evidence on which to base sample size calculations for a future trial of whether spironolactone (an aldosterone blocker) reduces knee pain in older people with symptomatic OA knee when given in addition to usual analgesia. Aldosterone is known to be pro-inflammatory, and spironolactone suppresses cytokine production in chronic arthritis. This application builds on previous work by the applicants showing that spironolactone significantly improved quality of life (particularly pain) in frail older people. The investigators will recruit 86 people (aged 70 years or over) with well-defined OA knee to 25mg spironolactone daily or to matching placebo for 12 weeks. The primary outcome is the between group difference in change in WOMAC pain sub-score at 12 weeks. Secondary outcomes are the WOMAC stiffness and physical function subscales and health related quality of life (EQ-5D). Morning cortisol levels will be measured to assess the effect of mineralocorticoid receptor blockade on glucocorticoid levels, which may mediate the anti-inflammatory effect of spironolactone; and urinary CTX-II, and serum matrix metalloproteinase-3 (MMP-3) will be measured as biomarkers as both are sensitive to the effects of pharmacological interventions for osteoarthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

Osteoarthritis of knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

spironolactone

Arm Type

Active Comparator

Arm Description

25mg spironolactone daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matched Placebo

Intervention Type

Drug

Intervention Name(s)

spironolactone

Other Intervention Name(s)

Aldactone

Intervention Description

spironolactone 25mg daily for 12 weeks

Primary Outcome Measure Information:

Title

Between group difference in change in WOMAC pain subscale (5 items)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Between group difference in change in WOMAC stiffness subscale.

Time Frame

12 weeks

Other Pre-specified Outcome Measures:

Title

Between group difference in change in WOMAC physical function subscales.

Time Frame

12 weeks

Title

Between group difference in change in health-related quality of life measured by EQ-5D questionnaire.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant is willing and able to give informed consent Community dwelling Aged 70 years and over Symptomatic idiopathic OA knee according to American College of Rheumatology clinical and radiographic criteria (ie Knee pain - with or without crepitus and presence of osteophytes on x ray) To avoid floor effects, participants will require to have moderate (or more severe) pain at screening in at least 2 out of 5 WOMAC pain score items To have been in receipt (prescription or/and over the counter) of one or more analgesic agents at a therapeutic dose for at least 2 months Willing to have knee x-ray if one has not been taken in preceding 12 months Exclusion Criteria: Clinical diagnosis of symptomatic heart failure History of inflammatory arthritis Already taking spironolactone Previous intolerance to spironolactone Known allergies to spironolactone or lactose Objection to taking capsules made from animal sourced gelatine Taking oral NSAIDs (because of the increased risk of renal impairment when combined with spironolactone) Taking ACE inhibitors or ARBs (angiotensin II receptor antagonists). ARBs have many properties similar to those of ACE inhibitors. Both will be exclusion because of the increased risk of acute kidney injury and hyperkalaemia, and because our previous study also excluded those on ACE inhibitors (and ARBs) and treatment was safe and well tolerated. Supine hypotension (supine systolic blood pressure <100mmHg at screening) Significant chronic kidney disease (eGFR<40ml/min) Serum sodium<130mmol/l Serum potassium>5.0mmol/l Symptomatic orthostatic hypotension (measured at screening) Nursing home resident Wheelchair bound Participating in another clinical trial (other than observational trials and registries) concurrently or within 30 days prior to screening for entry into this study Known contraindication to spironolactone therapy Participant who is terminally ill, defined as less than 3 months expected survival

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marion ET McMurdo, MBChB, MD

Organizational Affiliation

University of Dundee

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Miles Witham, BM BCh, MRCP

Organizational Affiliation

University of Dundee

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Vera Cvoro, Mb CHB, MRCP

Organizational Affiliation

NHS Fife

Official's Role

Principal Investigator

Facility Information:

Facility Name

NHS Fife

City

Kirkcaldy

State/Province

Fife

ZIP/Postal Code

KY2 5AH

Country

United Kingdom

Facility Name

NHS Tayside

City

Dundee

State/Province

Tayside

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/26413749

Description

Related Info

Learn more about this trial

The Effect of Spironolactone on Pain in Older People With Osteoarthritis

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