Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00283595
• Collaborator: Genentech, Inc. (Industry)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

Decreased bone strength is a serious medical problem present in many women with Anorexia Nervosa, or disordered eating. Women with weaker bones are more likely to suffer broken bones than women with normal bone strength.

We are investigating whether a hormone that is naturally produced by the human body, called growth hormone, can help strengthen the bones of women with this type of disordered eating.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa; Osteopenia; Osteoporosis; Eating Disorders	Drug: Recombinant Human Growth Hormone; Drug: Placebo for Recombinant Human Growth Hormone	Phase 2

Detailed Description

• Twelve week study

• Eight visits, six of which can be conducted at your home physician's office

• Two bone density scans

• Hormonal and nutritional evaluations

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effect of Supraphysiological rhGH on Bone Metabolism in Patients With Anorexia Nervosa
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Treatment with rHGH	Drug: Recombinant Human Growth Hormone; Dosage increased in steps for first four weeks. Self injection qd x 12 weeks; Other Names: Nutropin AQ
Placebo Comparator: 2 Treatment with Placebo	Drug: Placebo for Recombinant Human Growth Hormone; Administered as Arm 1, rHGH active Injection qd x 12 weeks Dosage increase over four weeks; Other Names: Placebo for Nutropin AQ

Outcome Measures

Primary Outcome Measures

1. Bone Metabolism [Baseline, 12 weeks]

   Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks

Secondary Outcome Measures

1. IGF-1 Level [Baseline, 12 Weeks]

   Change in IGF-1 level between baseline and 12 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• women between 14 to 45 years with anorexia nervosa

Exclusion Criteria:

• pregnancy

• previous history of malignancy.

• oral contraceptive pills or other hormones within last 8 - 12 weeks

• medications known to affect bone within last 12 weeks

• fracture within last 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusettes General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• Genentech, Inc.

Investigators

• Principal Investigator: Anne Klibanski, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Karen Klahr Miller, MD, Chief, Neuroendocrine Unit, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00283595
• Other Study ID Numbers: 2005-P-001443/3; MGH
• First Posted: Jan 30, 2006
• Last Update Posted: Sep 2, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by Karen Klahr Miller, MD, Chief, Neuroendocrine Unit, Massachusetts General Hospital: Anorexia Nervosa; Eating disorder; Bone; Growth hormone; Osteopenia; Osteoporosis
• Additional relevant MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Anorexia; Feeding and Eating Disorders; Anorexia Nervosa; Hormones

Study Results

Participant Flow

Recruitment Details	Subjects were referred from by local eating disorders providers and were recruited from on-line advertisements. Recruitment period: April 2006 through November 2008.

Arm/Group Title	Recombinant Human Growth Hormone(Subcutaneous Daily Injection)	Placebo (Subcutaneous Daily Injection)
Arm/Group Description	Treatment with rHGH	Treatment with Placebo
Period Title: Overall Study
STARTED	10	11
COMPLETED	9	9
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Recombinant Human Growth Hormone Group	Placebo Group	Total
Arm/Group Description	Treatment with rHGH	Treatment with Placebo	Total of all reporting groups
Overall Participants	10	11	21
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.0 (6.7)	29.2 (8.6)	28.7 (7.5)
Sex: Female, Male (Count of Participants)
Female	10 100%	11 100%	21 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%	11 100%	21 100%

Outcome Measures

1. Primary Outcome

Title	Bone Metabolism
Description	Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks
Time Frame	Baseline, 12 weeks

Outcome Measure Data

Analysis Population Description

Only subjects who completed study visits after the baseline visit were included in the analysis. The three subjects who discontinued the study only completed a baseline visit and were therefore not included in the analysis.

Arm/Group Title	Recombinant Human Growth Hormone Group	Placebo Group
Arm/Group Description	Treatment with rHGH	Treatment with Placebo
Measure Participants	9	9
Mean (Standard Error) [ng/ml]	34.3 (16.7)	10.4 (7.1)

2. Secondary Outcome

Title	IGF-1 Level
Description	Change in IGF-1 level between baseline and 12 weeks
Time Frame	Baseline, 12 Weeks

Outcome Measure Data

Analysis Population Description

The analysis group consisted of individuals who completed study visits after the baseline visit. The three subjects who did not continue in the study discontinued their participation after the baseline visit.

Arm/Group Title	Recombinant Human Growth Hormone Group	Placebo Group
Arm/Group Description	Treatment with rHGH	Treatment with Placebo
Measure Participants	9	9
Median (Inter-Quartile Range) [ng/ml]	6.5	10

Adverse Events

Arm/Group Title	Recombinant Human Growth Hormone Group		Placebo Group
Arm/Group Description	Treatment with rHGH		Treatment with Placebo
All Cause Mortality
	Recombinant Human Growth Hormone Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Recombinant Human Growth Hormone Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Recombinant Human Growth Hormone Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/10 (80%)		9/11 (81.8%)
Endocrine disorders
Polyuria	2/10 (20%)	2	0/11 (0%)	0
Eye disorders
Blurry vision	1/10 (10%)	1	0/11 (0%)	0
Gastrointestinal disorders
Constipation	3/10 (30%)	4	5/11 (45.5%)	12
Abdominal Pain	2/10 (20%)	2	4/11 (36.4%)	7
Nausea	3/10 (30%)	6	3/11 (27.3%)	3
Vomiting	0/10 (0%)	0	2/11 (18.2%)	3
General disorders
Edema	4/10 (40%)	4	1/11 (9.1%)	2
Lightheadedness	3/10 (30%)	6	5/11 (45.5%)	7
Cold intolerance	0/10 (0%)	0	3/11 (27.3%)	6
Polydypsia	0/10 (0%)	0	1/11 (9.1%)	3
Musculoskeletal and connective tissue disorders
Arthralgias	2/10 (20%)	4	2/11 (18.2%)	3
Paresthesias (carpal tunnel symptoms)	1/10 (10%)	1	0/11 (0%)	0
Nervous system disorders
Headache	5/10 (50%)	9	4/11 (36.4%)	5
Psychiatric disorders
Depressive symptoms	2/10 (20%)	2	4/11 (36.4%)	6
Skin and subcutaneous tissue disorders
Irritation at injection site	1/10 (10%)	1	1/11 (9.1%)	4
Rash	0/10 (0%)	0	1/11 (9.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.