Bisphosphonates for the Treatment of Seropositive Musculoskeletal Complaints

NCT04115397 | Unknown Phase 4

• 1 other identifier: 2018/682-31
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Seropositive Rheumatoid arthritis (RA) is characterized by autoantibodies that develop prior to clinical onset, allowing identification of individuals at risk for disease development. In a unique program in Stockholm, seropositive individuals presenting with musculoskeletal complains are currently identified and followed-up in a dedicated outpatient clinical program. Despite significant disease burden and increased sick leave among these individuals, we lack today any therapeutic and preventive measures. We aim to (1). establish a nation-wide health program, (2). develop an algorithm for disease risk estimation and (3). test a novel strategy to delay and/or prevent disease onset in seropositive at risk individuals with musculoskeletal complains. We will perform a multicentre randomised study to treat autoantibody-positive individuals at risk for developing RA presenting with pain (Population), by repurposing of bisphosphonates (Intervention) as compared to placebo (Control) to treat pain (primary Outcome) and delay/prevent RA development during 1-year follow-up (secondary Outcome)

Conditions

Seropositive Muskuloskeletal Complaints

Outcome Measures

Primary Outcomes (1)

• VAS pain

  PAin on a visual analogue scale

  3 months

Secondary Outcomes (3)

• HAQ

  3 months

• MRI

  6 months

• Rheumatoid Arthritis (RA ) diagnosis

  1 year

Study Arms (2)

Bisphophonate

EXPERIMENTAL

Zolendronic acid, one infusion iv

Drug: Zoledronic Acid

Placebo

PLACEBO COMPARATOR

Placebo, one infusion iv

Drug: Placebo

Interventions

Zoledronic Acid DRUG

Treating seropositive individuals with musculoskeletal symptoms with one infusion zolendronic acid as compared to placebo

Bisphophonate

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 18 years Lack of arthritis as estimated by clinical and ultrasound examination of the joints ACPA positive Intermediate or high risk for RA (according to the algorithm described above) VAS score of at least 20 mm

You may not qualify if:

• A previous diagnosis of arthritis Intolerance/contraindication to any of the study medications

Sponsors & Collaborators

• Karolinska Institutet: lead

MeSH Terms

Interventions

Zoledronic Acid

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: January 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share