Trial Outcomes & Findings for Effects of Exemestane on Bone Strength (NCT NCT01144468)

NCT ID: NCT01144468

Last Updated: 2024-03-27

Results Overview

Mean percent change in total volumetric bone mineral density (BMD) measured by high resolution peripheral quantitative computer tomography )HR-pQCT from baseline to 24 months

• Recruitment status: COMPLETED
• Target enrollment: 351 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2024-03-27

Participant Flow

Participant milestones

Measure	Exemestane In MAP.3 participants were randomly assigned to 25 mg exemestane daily or placebo for 5 years.	Placebo In MAP.3 participants were randomly assigned to 25 mg exemestane daily or placebo for 5 years.
Overall Study STARTED	176	175
Overall Study COMPLETED	124	118
Overall Study NOT COMPLETED	52	57

Reasons for withdrawal

Measure	Exemestane In MAP.3 participants were randomly assigned to 25 mg exemestane daily or placebo for 5 years.	Placebo In MAP.3 participants were randomly assigned to 25 mg exemestane daily or placebo for 5 years.
Overall Study Lost to Follow-up	4	7
Overall Study Adverse Event	3	2
Overall Study did not reach 2 year follow up at time of clinical cut off	45	48

Baseline Characteristics

Effects of Exemestane on Bone Strength

Baseline characteristics by cohort

Measure	Exemestane 25 mg Daily n=176 Participants	Placebo n=175 Participants	Total n=351 Participants Total of all reporting groups
Age, Continuous	61.3 years n=5 Participants	61.1 years n=7 Participants	61.2 years n=5 Participants
Sex: Female, Male Female	176 Participants n=5 Participants	175 Participants n=7 Participants	351 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	00 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	166 Participants n=5 Participants	162 Participants n=7 Participants	328 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: This is an observational study of participants in the MAP.3 breast cancer prevention randomized controlled trial. In MAP.3 participants were randomly assigned to either placebo or 25 mg exemestane daily for 5 years. Allocation was blinded. We are following 354 of these study participants and are blinded to treatment allocation.

Mean percent change in total volumetric bone mineral density (BMD) measured by high resolution peripheral quantitative computer tomography )HR-pQCT from baseline to 24 months

Outcome measures

Measure	MAP3 Participants on 25 mg Exemestane Daily n=176 Participants	MAP3 Participants on Placebo n=175 Participants
Mean Percent Change in Total Volumetric Bone Mineral Density (BMD) Measured by High Resolution Peripheral Quantitative Computer Tomography (HR-PQCT) From Baseline to 24 Months	-6.1 mean percent change Interval -7.0 to -5.2	-1.8 mean percent change Interval -2.4 to -1.2

Adverse Events

MAP3 Participants on 25 mg Exemestane Daily

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

MAP3 Participants on Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MAP3 Participants on 25 mg Exemestane Daily n=176 participants at risk MAP3 treatment arm	MAP3 Participants on Placebo n=175 participants at risk MAP3 placebo arm
Musculoskeletal and connective tissue disorders Bone related adverse event	1.7% 3/176 • Number of events 3 • 2 years Women discontinued the study if their lumbar spine, total hip, or femoral neck areal BMD dropped 10% or more in the preceding year, their T-scores fell to or below -2·5, or if they sustained fragility fractures or started taking drugs for bone-related disorders	1.1% 2/175 • Number of events 2 • 2 years Women discontinued the study if their lumbar spine, total hip, or femoral neck areal BMD dropped 10% or more in the preceding year, their T-scores fell to or below -2·5, or if they sustained fragility fractures or started taking drugs for bone-related disorders

Additional Information

Dr. Angela Cheung

University Health Network

Phone: 416-340-4841

Email: jscher@uhnresearch.ca

Results disclosure agreements

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