Trial Outcomes & Findings for Changes in Knee Articular Cartilage Volume in Women on Aromatase Inhibitors (NCT NCT00111241)

NCT ID: NCT00111241

Last Updated: 2018-12-14

Results Overview

change in medial and lateral articular tibial cartilage volume over two years

• Recruitment status: COMPLETED
• Target enrollment: 115 participants
• Primary outcome timeframe: Baseline, two years
• Results posted on: 2018-12-14

Participant Flow

Participant milestones

Measure	Women With Breast Cancer women with hormone receptor positive ( HR+) breast cancer, prescribed an aromatase inhibitor (AI)	Healthy Control Group healthy postmenopausal aged-matched controls from prior data base
Overall Study STARTED	45	70
Overall Study COMPLETED	30	62
Overall Study NOT COMPLETED	15	8

Reasons for withdrawal

Measure	Women With Breast Cancer women with hormone receptor positive ( HR+) breast cancer, prescribed an aromatase inhibitor (AI)	Healthy Control Group healthy postmenopausal aged-matched controls from prior data base
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	4	0
Overall Study Protocol Violation	9	8
Overall Study Adverse Event	1	0

Baseline Characteristics

Changes in Knee Articular Cartilage Volume in Women on Aromatase Inhibitors

Baseline characteristics by cohort

Measure	Women With Breast Cancer on Aromatase Inhibitor Therapy n=45 Participants women with hormone receptor positive breast cancer prescribed an aromatase inhibitor	Control n=70 Participants healthy postmenopausal aged-matched controls from prior data base	Total n=115 Participants Total of all reporting groups
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	70 Participants n=7 Participants	115 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	70 Participants n=7 Participants	115 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Australia	45 participants n=5 Participants	70 participants n=7 Participants	115 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, two years

change in medial and lateral articular tibial cartilage volume over two years

Outcome measures

Measure	Women With Breast Cancer n=30 Participants women recruited with HR+ breast cancer prescribed an AI	Control n=62 Participants healthy postmenopausal aged-matched controls from prior data base
Knee Cartilage Volume	2042 mm³ Standard Deviation 151	1971 mm³ Standard Deviation 207

SECONDARY outcome

Timeframe: Baseline, Two years

change in subchondral bone expansion area over two years

Outcome measures

Measure	Women With Breast Cancer n=45 Participants women recruited with HR+ breast cancer prescribed an AI	Control n=70 Participants healthy postmenopausal aged-matched controls from prior data base
Knee Subchondral Bone Expansion	2020 mm² Standard Deviation 180	1992 mm² Standard Deviation 204

Adverse Events

Women With Breast Cancer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof Susan Davis

Monash University

Phone: +61399030827

Email: susan.davis@monash.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place