Trial Outcomes & Findings for A Study of Actonel for the Prevention of Bone Loss (NCT NCT00452439)
NCT ID: NCT00452439
Last Updated: 2020-12-28
Results Overview
bone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 6 months.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
72 participants
Primary outcome timeframe
6 months
Results posted on
2020-12-28
Participant Flow
Recruitment Period: February 06, 2004 to March 10, 2010. All participants were recruited at University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
Actonel
Actonel (Risedronate) + Vitamin D + Calcium
Actonel 35 mg orally weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months.
|
Placebo
Placebo + Vitamin D + Calcium
Placebo weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
22
|
29
|
|
Overall Study
NOT COMPLETED
|
14
|
7
|
Reasons for withdrawal
| Measure |
Actonel
Actonel (Risedronate) + Vitamin D + Calcium
Actonel 35 mg orally weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months.
|
Placebo
Placebo + Vitamin D + Calcium
Placebo weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Refused Treatment
|
4
|
3
|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Bone Marrow Transplant
|
0
|
1
|
|
Overall Study
Too Ill to Continue
|
0
|
1
|
|
Overall Study
Failed to achieve complete response
|
2
|
0
|
|
Overall Study
Relapse
|
3
|
0
|
|
Overall Study
Fracture
|
1
|
0
|
Baseline Characteristics
A Study of Actonel for the Prevention of Bone Loss
Baseline characteristics by cohort
| Measure |
Actonel
n=36 Participants
Actonel (Risedronate) + Vitamin D + Calcium
Actonel 35 mg orally weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months.
|
Placebo
n=36 Participants
Placebo + Vitamin D + Calcium
Placebo weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
n=5 Participants
|
42 years
n=7 Participants
|
36 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 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
|
|
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
|
0 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
36 participants
n=7 Participants
|
72 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Of 72 randomized, 22 participants in risedronate \& 29 in placebo had at least a 6-month follow-up bone mineral density and were considered evaluable for the primary endpoint. Only 12/22 patients (55%) in risedronate and 7/29 patients (24%) in the placebo arm had 12 month DXA scan performed, mostly due to significant decreases in bone density.
bone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 6 months.
Outcome measures
| Measure |
Actonel
n=22 Participants
Actonel (Risedronate) + Vitamin D + Calcium
Actonel 35 mg orally weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months.
|
Placebo
n=29 Participants
Placebo + Vitamin D + Calcium
Placebo weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months.
|
|---|---|---|
|
Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at the 6 Months
Lumbar Spine 6 Months
|
-2.4 Percent of change
Standard Deviation 0.05
|
-3.5 Percent of change
Standard Deviation 0.04
|
|
Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at the 6 Months
Right Hip 6 Months
|
-7.6 Percent of change
Standard Deviation 0.06
|
-11 Percent of change
Standard Deviation 0.06
|
|
Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at the 6 Months
Left Hip 6 Months
|
-8.2 Percent of change
Standard Deviation 0.06
|
-11 Percent of change
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: 12 monthsbone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 12 months
Outcome measures
| Measure |
Actonel
n=12 Participants
Actonel (Risedronate) + Vitamin D + Calcium
Actonel 35 mg orally weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months.
|
Placebo
n=7 Participants
Placebo + Vitamin D + Calcium
Placebo weekly, Calcium 500 mg orally twice a day, and Vitamin D 400 IU orally twice a day for a total of 24 months.
|
|---|---|---|
|
Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at 12 Months
Lumbar Spine 12 Months
|
-0.6 percentage of change
Standard Deviation 0.05
|
-5 percentage of change
Standard Deviation 0.05
|
|
Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at 12 Months
Right Hip 12 Months
|
-4.8 percentage of change
Standard Deviation 0.05
|
-5.8 percentage of change
Standard Deviation 0.05
|
|
Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at 12 Months
Left Hip 12 Months
|
-4.1 percentage of change
Standard Deviation 0.05
|
-7 percentage of change
Standard Deviation 0.03
|
Adverse Events
Actonel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Maria Cabanillas, Associate Professor, Endocrine Neoplasia and HD
University of Texas (UT) MD Anderson Cancer Center
Phone: (713) 563-0764
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place