Trial Outcomes & Findings for Bone Loss in Women With Anorexia Nervosa (NCT NCT00089843)
NCT ID: NCT00089843
Last Updated: 2020-09-02
Results Overview
Percent change in postero-anterior (PA) spine bone mineral density as measured by dual energy x-ray absorptiometry (DXA)over a 12-month period. The differences in log-transformed values are reported as percent change.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
77 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2020-09-02
Participant Flow
Participant milestones
| Measure |
Placebo Actonel and Active Testosterone Patch
Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
|
Active Actonel and Active Testosterone Patch
Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
|
Active Actonel and Placebo Testosterone
Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
|
Placebo Testosterone Patch and Placebo Actonel
Placebo Testosterone Patch and placebo Actonel tablet
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
20
|
18
|
|
Overall Study
COMPLETED
|
17
|
16
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
5
|
7
|
Reasons for withdrawal
| Measure |
Placebo Actonel and Active Testosterone Patch
Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
|
Active Actonel and Active Testosterone Patch
Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
|
Active Actonel and Placebo Testosterone
Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
|
Placebo Testosterone Patch and Placebo Actonel
Placebo Testosterone Patch and placebo Actonel tablet
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
5
|
6
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Bone Loss in Women With Anorexia Nervosa
Baseline characteristics by cohort
| Measure |
Placebo Actonel and Active Testosterone Patch
n=19 Participants
Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
|
Active Actonel and Active Testosterone Patch
n=20 Participants
Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
|
Active Actonel and Placebo Testosterone
n=20 Participants
Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
|
Placebo Testosterone Patch and Placebo Actonel
n=18 Participants
Placebo Testosterone Patch and placebo Actonel tablet
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
77 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 7.3 • n=93 Participants
|
25.2 years
STANDARD_DEVIATION 6.2 • n=4 Participants
|
25.3 years
STANDARD_DEVIATION 6.3 • n=27 Participants
|
26.9 years
STANDARD_DEVIATION 7.2 • n=483 Participants
|
26.1 years
STANDARD_DEVIATION 6.7 • n=36 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
77 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=93 Participants
|
20 participants
n=4 Participants
|
20 participants
n=27 Participants
|
18 participants
n=483 Participants
|
77 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: 1 subject was excluded from analysis. A factorial analysis was performed and determines the effect of each intervention separately, whether or not a subject received the 2nd intervention. Therefore, data from all 76 subjects who participated were used to determine the effect of each intervention on our endpoints.
Percent change in postero-anterior (PA) spine bone mineral density as measured by dual energy x-ray absorptiometry (DXA)over a 12-month period. The differences in log-transformed values are reported as percent change.
Outcome measures
| Measure |
Actonel (Risedronate) 35 mg Weekly
n=40 Participants
Actonel (risedronate) 35 mg, 1 tablet weekly
|
Testosterone
n=39 Participants
Testosterone, initial dose 150 mcg transdermal daily, increased to 300 mcg daily in women with free testosterone levels below the median (n=25 women)
|
|---|---|---|
|
Bone Mineral Density
|
3.2 percent change
Interval 1.8 to 4.6
|
-0.6 percent change
Interval -2.0 to 0.8
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 1 subject was excluded from analysis. A factorial analysis was performed and determines the effect of each intervention separately, whether or not a subject received the 2nd intervention. Therefore, data from all 76 subjects who participated were used to determine the effect of each intervention on our endpoints.
type 1 collagen C-telopeptide(CTX); The differences in log-transformed values are reported as percent change.
Outcome measures
| Measure |
Actonel (Risedronate) 35 mg Weekly
n=40 Participants
Actonel (risedronate) 35 mg, 1 tablet weekly
|
Testosterone
n=39 Participants
Testosterone, initial dose 150 mcg transdermal daily, increased to 300 mcg daily in women with free testosterone levels below the median (n=25 women)
|
|---|---|---|
|
Markers of Bone Metabolism
|
-41 percent change of CTX
Interval -65.0 to -17.0
|
-11 percent change of CTX
Interval -35.0 to 13.0
|
Adverse Events
Placebo Actonel and Active Testosterone Patch
Serious events: 6 serious events
Other events: 12 other events
Deaths: 0 deaths
Active Actonel and Active Testosterone Patch
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Active Actonel and Placebo Testosterone
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo Testosterone Patch and Placebo Actonel
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Actonel and Active Testosterone Patch
n=19 participants at risk
Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
|
Active Actonel and Active Testosterone Patch
n=20 participants at risk
Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
|
Active Actonel and Placebo Testosterone
n=20 participants at risk
Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
|
Placebo Testosterone Patch and Placebo Actonel
n=18 participants at risk
Placebo Testosterone Patch and placebo Actonel tablet
|
|---|---|---|---|---|
|
Psychiatric disorders
Hospitalization related to underlying condition (anorexia nervosa)
|
31.6%
6/19 • Number of events 16 • 1 year
|
5.0%
1/20 • Number of events 11 • 1 year
|
25.0%
5/20 • Number of events 13 • 1 year
|
11.1%
2/18 • Number of events 3 • 1 year
|
Other adverse events
| Measure |
Placebo Actonel and Active Testosterone Patch
n=19 participants at risk
Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
|
Active Actonel and Active Testosterone Patch
n=20 participants at risk
Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
|
Active Actonel and Placebo Testosterone
n=20 participants at risk
Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
|
Placebo Testosterone Patch and Placebo Actonel
n=18 participants at risk
Placebo Testosterone Patch and placebo Actonel tablet
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Mild irritation at patch site
|
47.4%
9/19 • Number of events 18 • 1 year
|
55.0%
11/20 • Number of events 27 • 1 year
|
40.0%
8/20 • Number of events 29 • 1 year
|
38.9%
7/18 • Number of events 15 • 1 year
|
|
Skin and subcutaneous tissue disorders
Mild increase in acne or oily skin
|
42.1%
8/19 • Number of events 21 • 1 year
|
65.0%
13/20 • Number of events 28 • 1 year
|
65.0%
13/20 • Number of events 33 • 1 year
|
66.7%
12/18 • Number of events 33 • 1 year
|
|
Skin and subcutaneous tissue disorders
Mild increase in body hair growth
|
31.6%
6/19 • Number of events 11 • 1 year
|
35.0%
7/20 • Number of events 12 • 1 year
|
15.0%
3/20 • Number of events 4 • 1 year
|
16.7%
3/18 • Number of events 14 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
15.8%
3/19 • Number of events 3 • 1 year
|
5.0%
1/20 • Number of events 2 • 1 year
|
10.0%
2/20 • Number of events 2 • 1 year
|
0.00%
0/18 • 1 year
|
|
Gastrointestinal disorders
Reflux
|
26.3%
5/19 • Number of events 8 • 1 year
|
15.0%
3/20 • Number of events 8 • 1 year
|
5.0%
1/20 • Number of events 3 • 1 year
|
33.3%
6/18 • Number of events 11 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place