MRI to monitor the effect of zoledronic acid in erosive psoriatic arthritis

Phase 1

Recruiting

• Conditions: Psoriatic arthritis; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12605000583640
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Psoriatic arthritis (according to Vasey and Espinoza criteria)Erosive PsA (bone lysis/ erosion peripheral joints on XR confirmed by a radiologist). Disease duration > 6 months. Suitable for MR scan* Adequate contraception if applicable DMARD, on a stable dose for 8 weeks prior to randomization Oral Prednisone no > 10mg daily at least 3 swollen and 3 tender joints.

Exclusion Criteria

Severe kidney, liver or heart disease Deranged calcium or Vit D levelsUveitis, Iritis, or chronic Conjunctivitis (or history of these conditions)Diabetic eye or kidney disease Uncontrolled diabetes, Hb1AC > 10 % Cancer (metastatic cancer or cancer diagnosed < 2 years ago) Is pregnant or planning pregnancy Severe dental problems or current dental infection, recent or impending dental surgery within three months of enrolmentOrthopaedic surgery within 3 months of enrolment Fractures (within the last 3 months) Use of Bisphosphonate therapy Participant in any biologics trial within 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To monitor MRI scans of dominant wrist and hand for change in bone erosion[];To monitor MRI scans of dominant wrist and hand for change in bone oedema score[]

Secondary Outcome Measures

Name	Time	Method
To monitor change in Sharp score (hands and feet) - both total and separately the erosion score component.[];To examine blood and urinary markers of bone turnover at 6 monthly intervals and compare these between the 2 groups.[];To examine bone mineral density (BMD) in the two groups.[];To examine osteoclast function at baseline and after 12 months in the 2 groups.[]