Trial Outcomes & Findings for Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa (NCT NCT00720122)
NCT ID: NCT00720122
Last Updated: 2021-11-18
Results Overview
Change in spine bone density over 6 months (6month data- baseline data). Bone density at the spine was assessed using dual energy x-ray absorptiometry at baseline and 6 months and the change in bone density over these 6 months was calculated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2021-11-18
Participant Flow
Participant milestones
| Measure |
Anorexia Nervosa Females
Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Anorexia Nervosa Females
Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
Baseline Characteristics
Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa
Baseline characteristics by cohort
| Measure |
Anorexia Nervosa Females
n=28 Participants
Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
|
|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
20.142857 years
STANDARD_DEVIATION 3.6180032 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: The study participants analyzed were those that completed the first 6 months of the study and had a bone density performed at the baseline visit and then again at the 6 month visit as per protocol.
Change in spine bone density over 6 months (6month data- baseline data). Bone density at the spine was assessed using dual energy x-ray absorptiometry at baseline and 6 months and the change in bone density over these 6 months was calculated.
Outcome measures
| Measure |
Anorexia Nervosa Females
n=19 Participants
Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
|
|---|---|
|
Change in Spine Bone Density (g/cm^2)
|
-0.00558 gm/cm^2
Standard Error 0.00653
|
Adverse Events
Anorexia Nervosa Females
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anorexia Nervosa Females
n=28 participants at risk
Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
|
|---|---|
|
General disorders
Hospitalization
|
14.3%
4/28 • Number of events 8 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Self-Injury
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
Other adverse events
| Measure |
Anorexia Nervosa Females
n=28 participants at risk
Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
|
|---|---|
|
General disorders
Itchiness at Injection Site
|
14.3%
4/28 • Number of events 6 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Facial Discoloration
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
2/28 • Number of events 2 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Fall
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
Gastrointestinal disorders
Food Poisoning
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Elevated Aspartate Aminotransferase
|
14.3%
4/28 • Number of events 9 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Severe Weight Loss
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Femoral Lymph Node Enlargement
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Bruising
|
14.3%
4/28 • Number of events 4 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Cold with Mild Nose Bleed
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Lightheaded and Pale at Blood Draw
|
3.6%
1/28 • Number of events 2 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Low Glucose Level
|
3.6%
1/28 • Number of events 2 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Elevated Alanine Aminotransferase
|
7.1%
2/28 • Number of events 2 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Heartburn
|
7.1%
2/28 • Number of events 2 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Achiness
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Spider Bite
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Mild Itchiness to Bilateral Lower Extremities
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Breast Bone Pain
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Dizziness
|
7.1%
2/28 • Number of events 2 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Soreness at Injection Site
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Low Potassium Level
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Nausea
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Lightheadedness
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Increased Fatigue
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Irritation at Injection Site
|
28.6%
8/28 • Number of events 11 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Papules at Injection Site
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Abdominal Bloating
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Burning Sensation at Injection Site
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Poison Ivy Rash
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Prominent Thyroid
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Swelling of Bilateral Feet
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Night Sweats
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Back Pain
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Joint Pain
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Hip Pain
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Headaches
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Erythema at Injection Site
|
14.3%
4/28 • Number of events 4 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Elevated Insulin-like Growth Factor 1
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Elevated Potassium Level
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Extremity Pain
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
General disorders
Occasional Bleeding at Injection Site
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
|
Renal and urinary disorders
Kidney Stone
|
3.6%
1/28 • Number of events 1 • For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
|
Additional Information
Madhusmita Misra, M.D., Associate Professor in Pediatrics, Assistant Pediatrician
Massachusetts General Hospital
Phone: 617-724-5602
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place