Status:
COMPLETED
IGF-1 and Bone Loss in Women With Anorexia Nervosa
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Anorexia Nervosa
Osteopenia
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 los...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT01406444
Start Date
October 1 2011
End Date
May 1 2019
Last Update
July 17 2020
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114