Trial Outcomes & Findings for IGF-1 and Bone Loss in Women With Anorexia Nervosa (NCT NCT01406444)
NCT ID: NCT01406444
Last Updated: 2020-07-17
Results Overview
Postero-anterior spine bone mineral density by dual-energy X-ray absorptiometry
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
148 participants
Primary outcome timeframe
12 Months
Results posted on
2020-07-17
Participant Flow
148 subjects were consented and screened, 90 subjects were randomized, and 82 subjects completed the baseline visit. Of the 90 who were randomized, 8 subjects did not attend their scheduled baseline visits and did not receive study medication.
Participant milestones
| Measure |
rhIGF-1 Followed by Risedronate
Sequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly
|
Risedronate
Risedronate 35mg PO once weekly for 12 months
|
Placebo
Placebo for 12 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
16
|
|
Overall Study
COMPLETED
|
23
|
24
|
14
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IGF-1 and Bone Loss in Women With Anorexia Nervosa
Baseline characteristics by cohort
| Measure |
rhIGF-1 Followed by Risedronate
n=33 Participants
Sequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly
|
Risedronate
n=33 Participants
Risedronate 35mg PO once weekly for 12 months
|
Placebo
n=16 Participants
Placebo for 12 months
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.9 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
28.1 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
25.4 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
27.5 years
STANDARD_DEVIATION 6.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Body mass index
|
18.4 kg/m2
STANDARD_DEVIATION 1.5 • n=5 Participants
|
18.4 kg/m2
STANDARD_DEVIATION 2.2 • n=7 Participants
|
18.6 kg/m2
STANDARD_DEVIATION 1.7 • n=5 Participants
|
18.4 kg/m2
STANDARD_DEVIATION 1.8 • n=4 Participants
|
|
Postero-anterior spine bone mineral density
|
0.88 g/cm2
STANDARD_DEVIATION 0.12 • n=5 Participants
|
0.86 g/cm2
STANDARD_DEVIATION 0.12 • n=7 Participants
|
0.88 g/cm2
STANDARD_DEVIATION 0.12 • n=5 Participants
|
0.88 g/cm2
STANDARD_DEVIATION 0.12 • n=4 Participants
|
|
Lateral spine bone mineral density
|
0.67 g/cm2
STANDARD_DEVIATION 0.09 • n=5 Participants
|
0.66 g/cm2
STANDARD_DEVIATION 0.09 • n=7 Participants
|
0.67 g/cm2
STANDARD_DEVIATION 0.07 • n=5 Participants
|
0.67 g/cm2
STANDARD_DEVIATION 0.09 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPostero-anterior spine bone mineral density by dual-energy X-ray absorptiometry
Outcome measures
| Measure |
rhIGF-1 Followed by Risedronate
n=23 Participants
Sequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly
|
Risedronate
n=24 Participants
Risedronate 35mg PO once weekly for 12 months
|
Placebo
n=14 Participants
Placebo for 12 months
|
|---|---|---|---|
|
Postero-anterior Spine Bone Mineral Density by DXA
|
0.891 g/cm2
Standard Error 0.014
|
0.887 g/cm2
Standard Error 0.014
|
0.874 g/cm2
Standard Error 0.013
|
SECONDARY outcome
Timeframe: 12 MonthsLateral spine bone mineral density by dual-energy X-ray absorptiometry
Outcome measures
| Measure |
rhIGF-1 Followed by Risedronate
n=23 Participants
Sequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly
|
Risedronate
n=24 Participants
Risedronate 35mg PO once weekly for 12 months
|
Placebo
n=14 Participants
Placebo for 12 months
|
|---|---|---|---|
|
Lateral Spine Bone Mineral Density by DXA
|
0.695 g/cm2
Standard Error 0.012
|
0.677 g/cm2
Standard Error 0.012
|
0.666 g/cm2
Standard Error 0.010
|
Adverse Events
rhIGF-1 Followed by Risedronate
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Risedronate
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
rhIGF-1 Followed by Risedronate
n=33 participants at risk
Sequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly
|
Risedronate
n=33 participants at risk
Risedronate 35mg PO once weekly for 12 months
|
Placebo
n=16 participants at risk
Placebo for 12 months
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection Site Irritation and/or Bruising
|
45.5%
15/33 • Number of events 24 • 1 year
|
33.3%
11/33 • Number of events 14 • 1 year
|
12.5%
2/16 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
3.0%
1/33 • Number of events 1 • 1 year
|
15.2%
5/33 • Number of events 14 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Upset Stomach
|
9.1%
3/33 • Number of events 3 • 1 year
|
3.0%
1/33 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
|
Gastrointestinal disorders
Acid Reflux
|
12.1%
4/33 • Number of events 6 • 1 year
|
9.1%
3/33 • Number of events 4 • 1 year
|
12.5%
2/16 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/33 • 1 year
|
6.1%
2/33 • Number of events 2 • 1 year
|
0.00%
0/16 • 1 year
|
|
General disorders
Headache
|
3.0%
1/33 • Number of events 1 • 1 year
|
3.0%
1/33 • Number of events 1 • 1 year
|
12.5%
2/16 • Number of events 2 • 1 year
|
|
General disorders
Achiness
|
3.0%
1/33 • Number of events 1 • 1 year
|
12.1%
4/33 • Number of events 5 • 1 year
|
0.00%
0/16 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/33 • 1 year
|
9.1%
3/33 • Number of events 3 • 1 year
|
0.00%
0/16 • 1 year
|
|
General disorders
Dizziness
|
0.00%
0/33 • 1 year
|
0.00%
0/33 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place