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Trial record 7 of 7 for:    "Osteoporosis" | "Anastrozole"

Changes in Knee Articular Cartilage Volume in Women on Aromatase Inhibitors

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ClinicalTrials.gov Identifier: NCT00111241
Recruitment Status : Completed
First Posted : May 19, 2005
Results First Posted : October 5, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Professor Susan Davis, Monash University

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition Arthralgia
Intervention Drug: aromatase inhibitors (letrozole, anastrozole)
Enrollment 115
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Women With Breast Cancer Healthy Control Group
Hide Arm/Group Description women with hormone receptor positive ( HR+) breast cancer, prescribed an aromatase inhibitor (AI) healthy postmenopausal aged-matched controls from prior data base
Period Title: Overall Study
Started 45 70
Completed 30 62
Not Completed 15 8
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             4             0
Protocol Violation             9             8
Adverse Event             1             0
Arm/Group Title Women With Breast Cancer on Aromatase Inhibitor Therapy Control Total
Hide Arm/Group Description women with hormone receptor positive breast cancer prescribed an aromatase inhibitor healthy postmenopausal aged-matched controls from prior data base Total of all reporting groups
Overall Number of Baseline Participants 45 70 115
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 70 participants 115 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
 100.0%
70
 100.0%
115
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 70 participants 115 participants
Female
45
 100.0%
70
 100.0%
115
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 45 participants 70 participants 115 participants
45 70 115
1.Primary Outcome
Title Knee Cartilage Volume
Hide Description change in medial and lateral articular tibial cartilage volume over two years
Time Frame Baseline, two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Women With Breast Cancer Control
Hide Arm/Group Description:
women recruited with HR+ breast cancer prescribed an AI
healthy postmenopausal aged-matched controls from prior data base
Overall Number of Participants Analyzed 30 62
Mean (Standard Deviation)
Unit of Measure: mm³
2042  (151) 1971  (207)
2.Secondary Outcome
Title Knee Subchondral Bone Expansion
Hide Description change in subchondral bone expansion area over two years
Time Frame Baseline, Two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Women With Breast Cancer Healthy Control Group
Hide Arm/Group Description:
women with hormone receptor positive ( HR+) breast cancer, prescribed an aromatase inhibitor (AI)
postmenopausal, nonhysterectomized, women not taking hormone replacement therapy,and with a body mass(BMI) between 20 and 37 kilograms per metre squared (kg/m2)
Overall Number of Participants Analyzed 45 70
Mean (Standard Deviation)
Unit of Measure: mm²
2020  (180) 1992  (204)
Time Frame Baseline, 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Women With Breast Cancer Control Group
Hide Arm/Group Description Of 45 women recruited with HR+ breast cancer prescribed an AI, 30 women provided paired MRI data, including 1 woman who withdrew at 0.8years due to metastatic disease. 3 women did not have even a baseline MRI (2 gave no reason and one withdrew with joint pain), 2 had no follow-up MRI, one stopped her AI, 3 cited personal reasons, one withdrew due to cancer complications, 3 changed to tamoxifen, one was lost to follow up and one gave no reason for withdrawal. Of 70 women participating as controls, 8 had missing MRI data
All-Cause Mortality
Women With Breast Cancer Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Women With Breast Cancer Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/70 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Women With Breast Cancer Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/70 (0.00%) 
Menopausal Symptoms and Well-being were previously entered as Secondary Outcome Measures. Data not available to assess these outcomes.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Prof Susan Davis
Organization: Monash University
Phone: +61399030827
Responsible Party: Professor Susan Davis, Monash University
ClinicalTrials.gov Identifier: NCT00111241     History of Changes
Other Study ID Numbers: 2004/949
First Submitted: May 18, 2005
First Posted: May 19, 2005
Results First Submitted: April 6, 2015
Results First Posted: October 5, 2018
Last Update Posted: December 14, 2018