Trial Outcomes & Findings for Effects of Anorexia Nervosa on Peak Bone Mass (NCT NCT01301183)
NCT ID: NCT01301183
Last Updated: 2021-07-13
Results Overview
Change in lumbar spine BMD z-score over 12 months as assessed by dual energy x-ray absorptiometry (DXA) The z-score indicates the number of standard deviations that BMD is away from the mean for age, sex and race. A z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher values. A positive change in z-scores indicates a favorable outcome whereas a negative change in z-scores indicates an unfavorable outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
75 participants
Primary outcome timeframe
12 months
Results posted on
2021-07-13
Participant Flow
Participant milestones
| Measure |
Rh IGF-1 + Transdermal Estradiol
RhIGF-1 with transdermal 17-beta estradiol
RhIGF-1 with transdermal 17-beta estradiol: RhIGF-1 will be started at a dose of 30mcg/k/dose twice daily, and will be titrated up or down in 25% dose increments to maintain IGF-1 levels in the upper half of the normal range.
Estradiol will be delivered transdermally using a 100 mcg patch (Vivelle Dot) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D.
|
Placebo + Transdermal Estradiol
Placebo and transdermal 17-beta estradiol
Placebo and transdermal 17-beta estradiol: Placebo injections will be administered twice daily.
Estradiol will be delivered transdermally using a patch (100 mcg) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
37
|
|
Overall Study
COMPLETED
|
12
|
21
|
|
Overall Study
NOT COMPLETED
|
26
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Anorexia Nervosa on Peak Bone Mass
Baseline characteristics by cohort
| Measure |
Rh IGF-1 + Transdermal Estradiol
n=38 Participants
RhIGF-1 with transdermal 17-beta estradiol
RhIGF-1 with transdermal 17-beta estradiol: RhIGF-1 will be started at a dose of 30mcg/k/dose twice daily, and will be titrated up or down in 25% dose increments to maintain IGF-1 levels in the upper half of the normal range.
Estradiol will be delivered transdermally using a 100 mcg patch (Vivelle Dot) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D.
|
Placebo + Transdermal Estradiol
n=37 Participants
Placebo and transdermal 17-beta estradiol
Placebo and transdermal 17-beta estradiol: Placebo injections will be administered twice daily.
Estradiol will be delivered transdermally using a patch (100 mcg) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
19.4 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
19.3 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
19.3 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
70 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
|
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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 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
|
38 participants
n=5 Participants
|
37 participants
n=7 Participants
|
75 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsChange in lumbar spine BMD z-score over 12 months as assessed by dual energy x-ray absorptiometry (DXA) The z-score indicates the number of standard deviations that BMD is away from the mean for age, sex and race. A z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher values. A positive change in z-scores indicates a favorable outcome whereas a negative change in z-scores indicates an unfavorable outcome.
Outcome measures
| Measure |
Rh IGF-1 + Transdermal Estradiol
n=12 Participants
RhIGF-1 with transdermal 17-beta estradiol
RhIGF-1 with transdermal 17-beta estradiol: RhIGF-1 will be started at a dose of 30mcg/k/dose twice daily, and will be titrated up or down in 25% dose increments to maintain IGF-1 levels in the upper half of the normal range.
Estradiol will be delivered transdermally using a 100 mcg patch (Vivelle Dot) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D.
|
Placebo + Transdermal Estradiol
n=21 Participants
Placebo and transdermal 17-beta estradiol
Placebo and transdermal 17-beta estradiol: Placebo injections will be administered twice daily.
Estradiol will be delivered transdermally using a patch (100 mcg) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D.
|
|---|---|---|
|
Change in Bone Density Over a 12-month Period
|
0.045 score on a scale
Interval -0.083 to 0.174
|
0.280 score on a scale
Interval 0.085 to 0.475
|
SECONDARY outcome
Timeframe: 12 monthsChange in trabecular number at the ultradistal radius over 12 months as assessed by high resolution peripheral quantitative computed tomography (HRpQCT)
Outcome measures
| Measure |
Rh IGF-1 + Transdermal Estradiol
n=12 Participants
RhIGF-1 with transdermal 17-beta estradiol
RhIGF-1 with transdermal 17-beta estradiol: RhIGF-1 will be started at a dose of 30mcg/k/dose twice daily, and will be titrated up or down in 25% dose increments to maintain IGF-1 levels in the upper half of the normal range.
Estradiol will be delivered transdermally using a 100 mcg patch (Vivelle Dot) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D.
|
Placebo + Transdermal Estradiol
n=21 Participants
Placebo and transdermal 17-beta estradiol
Placebo and transdermal 17-beta estradiol: Placebo injections will be administered twice daily.
Estradiol will be delivered transdermally using a patch (100 mcg) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D.
|
|---|---|---|
|
Change in Trabecular Number at the Ultradistal Radius Over a 12-month Period
|
-0.10 1/mm
Interval -0.18 to -0.02
|
-0.02 1/mm
Interval -0.12 to 0.07
|
Adverse Events
Rh IGF-1 + Transdermal Estradiol
Serious events: 7 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo + Transdermal Estradiol
Serious events: 12 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rh IGF-1 + Transdermal Estradiol
n=38 participants at risk
RhIGF-1 with transdermal 17-beta estradiol
RhIGF-1 with transdermal 17-beta estradiol: RhIGF-1 will be started at a dose of 30mcg/k/dose twice daily, and will be titrated up or down in 25% dose increments to maintain IGF-1 levels in the upper half of the normal range.
Estradiol will be delivered transdermally using a 100 mcg patch (Vivelle Dot) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D.
|
Placebo + Transdermal Estradiol
n=37 participants at risk
Placebo and transdermal 17-beta estradiol
Placebo and transdermal 17-beta estradiol: Placebo injections will be administered twice daily.
Estradiol will be delivered transdermally using a patch (100 mcg) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D.
|
|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
5.3%
2/38 • 1 years
|
8.1%
3/37 • 1 years
|
|
Psychiatric disorders
Suicidal ideation
|
2.6%
1/38 • 1 years
|
5.4%
2/37 • 1 years
|
|
Psychiatric disorders
Hospitalization related to eating disorder
|
10.5%
4/38 • 1 years
|
18.9%
7/37 • 1 years
|
Other adverse events
| Measure |
Rh IGF-1 + Transdermal Estradiol
n=38 participants at risk
RhIGF-1 with transdermal 17-beta estradiol
RhIGF-1 with transdermal 17-beta estradiol: RhIGF-1 will be started at a dose of 30mcg/k/dose twice daily, and will be titrated up or down in 25% dose increments to maintain IGF-1 levels in the upper half of the normal range.
Estradiol will be delivered transdermally using a 100 mcg patch (Vivelle Dot) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D.
|
Placebo + Transdermal Estradiol
n=37 participants at risk
Placebo and transdermal 17-beta estradiol
Placebo and transdermal 17-beta estradiol: Placebo injections will be administered twice daily.
Estradiol will be delivered transdermally using a patch (100 mcg) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash at injection site
|
5.3%
2/38 • 1 years
|
0.00%
0/37 • 1 years
|
|
Skin and subcutaneous tissue disorders
Irritation at patch site
|
2.6%
1/38 • 1 years
|
5.4%
2/37 • 1 years
|
|
Reproductive system and breast disorders
Irregular menses
|
0.00%
0/38 • 1 years
|
8.1%
3/37 • 1 years
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/38 • 1 years
|
5.4%
2/37 • 1 years
|
|
Vascular disorders
Vasovagal with venipuncture
|
2.6%
1/38 • 1 years
|
8.1%
3/37 • 1 years
|
|
Vascular disorders
Dizziness with jitteriness
|
0.00%
0/38 • 1 years
|
5.4%
2/37 • 1 years
|
|
Nervous system disorders
Headache
|
5.3%
2/38 • 1 years
|
8.1%
3/37 • 1 years
|
|
Gastrointestinal disorders
Constipation
|
5.3%
2/38 • 1 years
|
5.4%
2/37 • 1 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/38 • 1 years
|
5.4%
2/37 • 1 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place