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Completed

NCT Number: NCT01406444

IGF-1 and Bone Loss in Women With Anorexia Nervosa

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.

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Key information

Conditions

Anorexia Nervosa Bone Diseases Bone Diseases, Metabolic Feeding and Eating Disorders Mental Disorders Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia Osteoporosis

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rhIGF-1

Drug

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

Other names: Increlex

risedronate

Drug

Risedronate 35mg PO one time weekly

Other names: Actonel

Placebo

Drug

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

Primary outcomes

  1. Postero-anterior Spine Bone Mineral Density by DXA

    Time frame: 12 Months

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

Secondary outcomes

  1. Lateral Spine Bone Mineral Density by DXA

    Time frame: 12 Months

    Lateral spine bone mineral density by dual-energy X-ray absorptiometry

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2011
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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