Effect of anastrozole on arthralgia and the effect of glucosamine sulphate supplementation in postmenopausal women with arthralgia in the IBIS-II breast cancer prevention trial

• Conditions: Relief of arthralgia, joint symptoms/stiffness with glucosamine sulphate; MedDRA version: 12.0Level: PTClassification code 10003239Term: Arthralgia; MedDRA version: 12.0Level: PTClassification code 10023230Term: Joint stiffness; MedDRA version: 12.0Level: HLTClassification code 10023226Term: Joint related signs and symptoms

• Registration Number: EUCTR2009-015378-36-GB
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

IBIS-II prevention women who developed treatment emergent arthralgia within 6 months of randomisation (i.e. arthralgia confirmed at the 6 months follow-up visit).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Women who have been recruited to the IBIS-II prevention trial over 12 months ago
•Women taking part in the Baseline Study (BS)
•Women taking the following medications on a regular basis for the relief of joint problems (e.g. arthralgia, joint pain, joint stiffness, etc):
oNon-steroidal anti-inflammatory drugs (NSAIDs) (e.g. Celecoxib, Etoricoxib, Parecoxib).
oGlusosamine sulphate
oAspirin
oParacetamol

Occasional (e.g. 1-2/month) use of Paracetamol or Aspirin for the relief of arthralgia symptoms (i.e. joint pain, joint stiffness, joint discomfort) is allowed.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To investigate the effect of glucosamine sulphate on arthralgia in postmenopausal women at increased risk of developing breast cancer.<br>;Secondary Objective: •To evaluate the effect of arthralgia on function by using a pain questionnaire and by employing functional assessment tests such as the grip test.<br>;Primary end point(s): The primary endpoint is the presence or absence of arthralgia after 6 months of follow-up