IGF-1 and Bone Loss in Women With Anorexia Nervosa
Tracking Information | |||||||||||||
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First Received Date ICMJE | July 26, 2011 | ||||||||||||
Last Updated Date | September 11, 2012 | ||||||||||||
Start Date ICMJE | October 2011 | ||||||||||||
Estimated Primary Completion Date | October 2016 (final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
Bone Mineral Density [ Time Frame: 12 Months ] [ Designated as safety issue: No ] Sequential therapy with physiologic rhIGF-1 followed by a bisphosphonate will increase bone mineral density in women with AN more than a bisphosphonate alone or placebo |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT01406444 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures ICMJE |
Bone Microarchitecture and strength [ Time Frame: 12 Months ] [ Designated as safety issue: No ] A significant improvement in bone microarchitecture and strength at the spine, ultradistal radius and tibia over a 12 month period. |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
Current Other Outcome Measures ICMJE | |||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | IGF-1 and Bone Loss in Women With Anorexia Nervosa | ||||||||||||
Official Title ICMJE | IGF-1 and Bone Loss in Women With Anorexia Nervosa | ||||||||||||
Brief 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. |
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Detailed Description | |||||||||||||
Study Type ICMJE | Interventional | ||||||||||||
Study Phase | |||||||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||
Estimated Enrollment ICMJE | 200 | ||||||||||||
Completion Date | |||||||||||||
Estimated Primary Completion Date | October 2016 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||||||||||
Ages | 18 Years to 45 Years | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT01406444 | ||||||||||||
Other Study ID Numbers ICMJE | 2R01DK052625 | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
Responsible Party | Anne Klibanski, MD, Massachusetts General Hospital | ||||||||||||
Study Sponsor ICMJE | Massachusetts General Hospital | ||||||||||||
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Investigators ICMJE |
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Information Provided By | Massachusetts General Hospital | ||||||||||||
Verification Date | September 2012 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |