CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 148 enrolled
Drug / intervention
rhIGF-1 +2 moredrug
Likely dose
rhIGF-1 30 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01406444
NCT01406444N/ACompleted

IGF-1 and Bone Loss in Women With Anorexia Nervosa

Massachusetts General Hospital·interventional·Posted Aug 1, 2011·Updated Jul 17, 2020

In Brief

A clinical study evaluating rhIGF-1, Risedronate, and 1 other intervention for Anorexia Nervosa and 2 related conditions. Completed, enrolled 148 participants across 1 site.

Detailed Summary

Anorexia nervosa is an eating disorder that can cause thinning of the bones (a decrease in bone density). A significant decrease in bone density is called osteopenia or osteoporosis. Sometimes the loss of bone density can be severe enough to cause breaks and fractures of the bones. It is not known what causes the bones to thin in anorexia nervosa. Women who have this condition often have thin or weak bones that are more likely to break. They also have very low levels of a chemical called IGF-1 in their body. This chemical is very important for increasing bone growth in puberty and for maintaining healthy adult bones. The investigators would like to find out if giving rhIGF-1 followed by risedronate or risedronate alone can lead to an increase in bone formation, bone density, and bone strength in women with anorexia nervosa.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 1, 2011
Enrollment StartOct 1, 2011
Primary CompletionMay 1, 2019
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 14.9 years ago

Interventions

rhIGF-1drug

Study participants will be started at a dose of 30 mcg/kg BID and will be titrated.

Risedronatedrug

Risedronate 35mg PO one time weekly

Placebodrug

Placebo injections 30 mcg/kg BID, Placebo tablet PO once weekly