IGF-1 and Bone Loss in Women With Anorexia Nervosa

Osteoporosis Clinical Trial

Official title:

IGF-1 and Bone Loss in Women With Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406444
• Other study ID #: 2R01DK052625
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: May 2019

Study information

• Verified date: July 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Bone Diseases, Metabolic
• Osteopenia
• Osteoporosis

Intervention

Drug:
• rhIGF-1
Study participants will be started at a dose of 30 mcg/kg BID and will be titrated.
• Risedronate
Risedronate 35mg PO one time weekly
• Placebo
Placebo injections 30 mcg/kg BID, Placebo tablet PO once weekly

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postero-anterior Spine Bone Mineral Density by DXA	Postero-anterior spine bone mineral density by dual-energy X-ray absorptiometry	12 Months
Secondary	Lateral Spine Bone Mineral Density by DXA	Lateral spine bone mineral density by dual-energy X-ray absorptiometry	12 Months