Trial Outcomes & Findings for Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy (NCT NCT00485953)
NCT ID: NCT00485953
Last Updated: 2017-10-13
Results Overview
BMD is the bone mineral density of the lumbar spine measured using the dual-energy x-ray absorptometry (DXA) scan.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
109 participants
Primary outcome timeframe
at 24 months
Results posted on
2017-10-13
Participant Flow
Participant milestones
| Measure |
Active Medication Group
risedronate 35 mg weekly
risedronate: risedronate 35 mg per week
|
Placebo Group
Received placebo medication once per week
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
54
|
|
Overall Study
COMPLETED
|
48
|
47
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy
Baseline characteristics by cohort
| Measure |
Active Medicine Group
n=55 Participants
risedronate 35 mg weekly
|
Placebo Group
n=54 Participants
Received placebo medication once per week
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
109 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
54 participants
n=7 Participants
|
109 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 24 monthsBMD is the bone mineral density of the lumbar spine measured using the dual-energy x-ray absorptometry (DXA) scan.
Outcome measures
| Measure |
Active Medicine Group
n=55 Participants
risedronate 35 mg weekly
|
Placebo Group
n=54 Participants
Received placebo medication once weekly
|
|---|---|---|
|
BMD of Spine by DXA
|
2.269 percentage change
Standard Error 0.583
|
-1.735 percentage change
Standard Error 0.611
|
SECONDARY outcome
Timeframe: at 24 monthsBMD is the bone mineral density of the femoral neck and total hip measured using the dual-energy x-ray absorptiometry (DXA) scan.
Outcome measures
| Measure |
Active Medicine Group
n=47 Participants
risedronate 35 mg weekly
|
Placebo Group
n=44 Participants
Received placebo medication once weekly
|
|---|---|---|
|
BMD by DXA at the Femoral Neck and Total Hip
Total Hip BMD
|
0.558 percentage change
Standard Error 0.370
|
-2.748 percentage change
Standard Error 0.487
|
|
BMD by DXA at the Femoral Neck and Total Hip
Femoral Neck BMD
|
0.408 percentage change
Standard Error 0.607
|
-2.137 percentage change
Standard Error 0.628
|
SECONDARY outcome
Timeframe: at 24 monthsOutcome measures
| Measure |
Active Medicine Group
n=48 Participants
risedronate 35 mg weekly
|
Placebo Group
n=47 Participants
Received placebo medication once weekly
|
|---|---|---|
|
Markers of Bone Resorption and Bone Formation
P1NP
|
-46.863 percentage change
Standard Error 3.025
|
-1.630 percentage change
Standard Error 5.732
|
|
Markers of Bone Resorption and Bone Formation
CTX
|
-14.906 percentage change
Standard Error 10.317
|
-4.077 percentage change
Standard Error 8.179
|
Adverse Events
Active Medicine Group
Serious events: 10 serious events
Other events: 52 other events
Deaths: 0 deaths
Placebo Group
Serious events: 16 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Medicine Group
n=55 participants at risk
risedronate 35 mg weekly
|
Placebo Group
n=54 participants at risk
Receive placebo medication once per week
|
|---|---|---|
|
Reproductive system and breast disorders
Breast related events
|
1.8%
1/55 • Number of events 1
|
3.7%
2/54 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal Events
|
0.00%
0/55
|
1.9%
1/54 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory related events
|
3.6%
2/55 • Number of events 2
|
0.00%
0/54
|
|
Cardiac disorders
Cardiovascular related events
|
9.1%
5/55 • Number of events 5
|
3.7%
2/54 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal related events
|
3.6%
2/55 • Number of events 2
|
9.3%
5/54 • Number of events 5
|
|
Infections and infestations
Infection related events
|
3.6%
2/55 • Number of events 2
|
5.6%
3/54 • Number of events 3
|
|
Renal and urinary disorders
Urogenital related events
|
0.00%
0/55
|
1.9%
1/54 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other cancers
|
0.00%
0/55
|
3.7%
2/54 • Number of events 2
|
|
General disorders
Other events
|
0.00%
0/55
|
7.4%
4/54 • Number of events 4
|
Other adverse events
| Measure |
Active Medicine Group
n=55 participants at risk
risedronate 35 mg weekly
|
Placebo Group
n=54 participants at risk
Receive placebo medication once per week
|
|---|---|---|
|
Reproductive system and breast disorders
Breast related events
|
7.3%
4/55 • Number of events 4
|
5.6%
3/54 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal related events
|
7.3%
4/55 • Number of events 4
|
22.2%
12/54 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory related events
|
3.6%
2/55 • Number of events 2
|
18.5%
10/54 • Number of events 10
|
|
Cardiac disorders
Cardiovascular related events
|
7.3%
4/55 • Number of events 4
|
18.5%
10/54 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal related events
|
49.1%
27/55 • Number of events 27
|
59.3%
32/54 • Number of events 32
|
|
Infections and infestations
Infection related events
|
23.6%
13/55 • Number of events 13
|
25.9%
14/54 • Number of events 14
|
|
Endocrine disorders
Endocrine related events
|
3.6%
2/55 • Number of events 2
|
7.4%
4/54 • Number of events 4
|
|
Renal and urinary disorders
Urogenital related events
|
5.5%
3/55 • Number of events 3
|
11.1%
6/54 • Number of events 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other cancers
|
7.3%
4/55 • Number of events 4
|
1.9%
1/54 • Number of events 1
|
|
General disorders
Other events
|
47.3%
26/55 • Number of events 26
|
48.1%
26/54 • Number of events 26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place