IGF-1 and Bone Loss in Women With Anorexia Nervosa

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Anne Klibanski, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01406444
First received: July 26, 2011
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Anorexia Nervosa
Osteopenia
Osteoporosis
Drug: rhIGF-1
Drug: Risedronate
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: IGF-1 and Bone Loss in Women With Anorexia Nervosa

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Sequential therapy with physiologic rhIGF-1 followed by a bisphosphonate will increase bone mineral density in women with AN more than a bisphosphonate alone or placebo


Secondary Outcome Measures:
  • Bone Microarchitecture and strength [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    A significant improvement in bone microarchitecture and strength at the spine, ultradistal radius and tibia over a 12 month period.


Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rhIGF-1 followed by Risedronate
Sequential therapy with rhIGF-1 for 6 months followed by 6 months of risedronate 35mg
Drug: rhIGF-1
Study participants will be started at a dose of 30 mcg/kg BID and will be titrated.
Other Name: Increlex
Drug: Risedronate
Risedronate 35mg PO one time weekly
Other Name: Actonel
Active Comparator: Risedronate
Risedronate 35mg for 12 months
Drug: Risedronate
Risedronate 35mg PO one time weekly
Other Name: Actonel
Placebo Comparator: Placebo
Placebo for 12 months
Drug: Placebo
Placebo injections 30 mcg/kg BID, Placebo tablet PO once weekly

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406444

Contacts
Contact: Erinne Meenaghan, NP 617-724-7393 emeenaghan@partners.org
Contact: Karen Miller, MD 617-726-3870 KKMiller@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Anne Klibanski, MD         
Sub-Investigator: Karen Miller, MD         
Sub-Investigator: Erinne Meenaghan, NP         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Anne Klibanski, MD Massachusetts General Hospital
Study Chair: Erinne Meenaghan, NP Massachusetts General Hospital
Study Director: Karen Miller, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Anne Klibanski, MD, Chief, Neuroendocrine Unit, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01406444     History of Changes
Other Study ID Numbers: 2R01DK052625
Study First Received: July 26, 2011
Last Updated: October 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Anorexia Nervosa
Osteopenia
Osteoporosis
Bone density

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Eating Disorders
Mental Disorders
Musculoskeletal Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Risedronic acid
Bone Density Conservation Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014