IGF-1 and Bone Loss in Women With Anorexia Nervosa
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anorexia Nervosa; Osteopenia; Osteoporosis
Intervention: rhIGF-1 (Drug); Risedronate (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s): Anne Klibanski, MD, Principal Investigator, Affiliation: Massachusetts General Hospital Erinne Meenaghan, NP, Study Chair, Affiliation: Massachusetts General Hospital Karen Miller, MD, Study Director, Affiliation: Massachusetts General Hospital
Overall contact: Erinne Meenaghan, NP, Phone: 617-724-7393, Email: emeenaghan@partners.org
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.
Clinical Details
Official title: IGF-1 and Bone Loss in Women With Anorexia Nervosa
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Bone Mineral Density
Secondary outcome: Bone Microarchitecture and strength
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Age 18-45 years
- AN defined by DSM-IV diagnostic criteria, including weight less than 85% of ideal
body weight (restricting or binge/purge type, BMI 15-17. 5) OR meet criteria for
sub-threshold AN, i. e., all DSM-IV criteria except that patients can have a BMI of
<18. 5 kg/m2 with or without amenorrhea
- Oral contraceptive use prior to enrollment
- BMD T score < -1. 0
- Normal FSH and TSH or free T4
- Normal serum 25-OH vitamin D (>20 ng/mL) and calcium levels
- Ongoing care from a primary care provider
- Agree to use barrier contraception
Exclusion Criteria:
- Any subject with contraindications to risedronate
- Any subject with binge-purge subtype of anorexia nervosa who vomits regularly as
their form of purging (vs. those who use laxatives or diuretics) and who have
significant periodontal disease, tooth erosion or an invasive dental or periodontal
procedure within the previous three months.
- Any disease known to affect bone, including untreated thyroid dysfunction, Cushing's
or renal failure
- Any medication known to affect bone metabolism within 3 months of the study,
excluding oral contraceptives. Bisphosphonates must have been discontinued for at
least one year before participation
- Serum potassium <3. 0 meq/L
- Serum ALT >3 times upper limit of normal
- eGFR of less than 30 ml/min
- Pregnant and/or breastfeeding
- Diabetes mellitus
- Active substance abuse, including alcohol
- History of malignancy
- Atraumatic fracture within the prior year
Locations and Contacts
Erinne Meenaghan, NP, Phone: 617-724-7393, Email: emeenaghan@partners.org
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting Anne Klibanski, MD, Principal Investigator Karen Miller, MD, Sub-Investigator Erinne Meenaghan, NP, Sub-Investigator
Additional Information
Starting date: October 2011
Last updated: March 21, 2015
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