FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-015378-36-GB
Enrollment
Unknown
Registered
2010-11-02
Start date
2009-12-23
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relief of arthralgia, joint symptoms/stiffness with glucosamine sulphate MedDRA version: 12.0 Level: PT Classification code 10003239 Term: Arthralgia MedDRA version: 12.0 Level: PT Classification code 10023230 Term: Joint stiffness MedDRA version: 12.0 Level: HLT Classification code 10023226 Term: Joint related signs and symptoms

Interventions

Trade Name: Glucosamine sulphate Pharmaceutical Form: Oral powder Pharmaceutical form of the placebo: Oral powder Route of administration of the placebo: Oral use

Sponsors

Queen Mary University of London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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): o Non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. Celecoxib, Etoricoxib, Parecoxib). o Glusosamine sulphate o Aspirin o Paracetamol 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.

Design outcomes

Primary

MeasureTime frame
Main Objective: • To investigate the effect of glucosamine sulphate on arthralgia in postmenopausal women at increased risk of developing breast cancer. ;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. ;Primary end point(s): The primary endpoint is the presence or absence of arthralgia after 6 months of follow-up—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026