IGF-1 and Bone Loss in Women With Anorexia Nervosa

NCT ID: NCT01406444

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2019-05-31

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.

Conditions

Anorexia Nervosa; Osteopenia; Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

rhIGF-1 followed by Risedronate

Sequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly

Group Type: ACTIVE_COMPARATOR

rhIGF-1

Intervention Type: DRUG

Study participants will be started at a dose of 30 mcg/kg BID and will be titrated.

Risedronate

Intervention Type: DRUG

Risedronate 35mg PO one time weekly

Risedronate

Risedronate 35mg PO once weekly for 12 months

Group Type: ACTIVE_COMPARATOR

Risedronate

Intervention Type: DRUG

Risedronate 35mg PO one time weekly

Placebo

Placebo for 12 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo injections 30 mcg/kg BID, Placebo tablet PO once weekly

Interventions

rhIGF-1

Study participants will be started at a dose of 30 mcg/kg BID and will be titrated.

Intervention Type: DRUG

Risedronate

Risedronate 35mg PO one time weekly

Intervention Type: DRUG

Placebo

Placebo injections 30 mcg/kg BID, Placebo tablet PO once weekly

Intervention Type: DRUG

Other Intervention Names

Increlex; Actonel

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Karen Klahr Miller, MD

Chief, Neuroendocrine Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Klibanski, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Erinne Meenaghan, NP

Role: STUDY_CHAIR

Massachusetts General Hospital

Karen Miller, MD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2R01DK052625

Identifier Type: NIH

Identifier Source: org_study_id

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