Trial · Interventional

CompletedPhase 2Results postedRegistry data

Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa

NCTNCT00283595Other id2005-P-001443/3; MGH

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 21 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Randomized · Single masking
Countries: 1 country
United States
Start: Jan 2006
Primary completion: Feb 2009
Completion: Feb 2009
First posted: 30 Jan 2006 (estimated)
Last update posted: 2 Sept 2020
Conditions: Anorexia Nervosa · Osteopenia · Osteoporosis · Eating Disorders

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20062007200820092010

Ph 2
Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa
NCT00283595
Jan 2006 to Feb 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Recombinant Human Growth HormoneDrug
Placebo for Recombinant Human Growth HormoneDrug

Arms2

Active comparator
1
Treatment with rHGH
Placebo comparator
2
Treatment with Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

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

Secondary outcomes(1)

IGF-1 Level
Time frame · Baseline, 12 Weeks
Registry description
Change in IGF-1 level between baseline and 12 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline, 12 weeks

Bone Metabolism

Group	Value (ng/ml)	Spread
Recombinant Human Growth Hormone Group	34.3	16.7
Placebo Group	10.4	7.1

Secondary and other outcome results(1)

Secondary outcomeMedian· Baseline, 12 Weeks

IGF-1 Level

Group	Value (ng/ml)
Recombinant Human Growth Hormone Group	6.5
Placebo Group	10

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Recombinant Human Growth Hormone GroupTreatment with rHGH	–	0 / 10	8 / 10
Placebo GroupTreatment with Placebo	–	0 / 11	9 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 14 Years up to 45 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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