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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

Page last updated: August 23, 2015

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