IGF-1 and Bone Loss in Women With Anorexia Nervosa

NCT01406444 | Completed Results DMC

• 1 other identifier: 2R01DK052625
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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

Keywords

Anorexia Nervosa; Osteopenia; Osteoporosis; Bone density

Outcome Measures

Primary Outcomes (1)

• Postero-anterior Spine Bone Mineral Density by DXA

  Postero-anterior spine bone mineral density by dual-energy X-ray absorptiometry

  12 Months

Secondary Outcomes (1)

• Lateral Spine Bone Mineral Density by DXA

  12 Months

Study Arms (3)

rhIGF-1 followed by Risedronate

ACTIVE COMPARATOR

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

Drug: rhIGF-1; Drug: Risedronate

Risedronate

ACTIVE COMPARATOR

Risedronate 35mg PO once weekly for 12 months

Drug: Risedronate

Placebo

PLACEBO COMPARATOR

Placebo for 12 months

Drug: Placebo

Interventions

rhIGF-1 DRUG

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

Also known as: Increlex

rhIGF-1 followed by Risedronate

Risedronate DRUG

Risedronate 35mg PO one time weekly

Also known as: Actonel

Risedronate; rhIGF-1 followed by Risedronate

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa; Bone Diseases, Metabolic; Osteoporosis

Interventions

mecasermin; Risedronic Acid

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Karen Klahr Miller
• Organization: Massachusetts General Hospital

kkmiller@mgh.harvard.org

6177263870

Study Officials

• Anne Klibanski, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Erinne Meenaghan, NP

  Massachusetts General Hospital

  STUDY CHAIR

• Karen Miller, MD

  Massachusetts General Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Neuroendocrine Unit

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: August 1, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 17, 2020
• Results First Posted: July 17, 2020

Record last verified: 2020-07

Locations

US (1)