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Trial record 65 of 101 for:    Risedronate

IGF-1 and Bone Loss in Women With Anorexia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01406444
Recruitment Status : Active, not recruiting
First Posted : August 1, 2011
Last Update Posted : January 11, 2019
Information provided by (Responsible Party):
Anne Klibanski, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Osteopenia Osteoporosis Drug: rhIGF-1 Drug: Risedronate Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: IGF-1 and Bone Loss in Women With Anorexia Nervosa
Study Start Date : October 2011
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Density

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Bone Mineral Density [ Time Frame: 12 Months ]
    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 :
  1. Bone Microarchitecture and strength [ Time Frame: 12 Months ]
    A significant improvement in bone microarchitecture and strength at the spine, ultradistal radius and tibia over a 12 month period.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01406444

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Anne Klibanski, MD Massachusetts General Hospital
Study Chair: Erinne Meenaghan, NP Massachusetts General Hospital
Study Director: Karen Miller, MD Massachusetts General Hospital

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Responsible Party: Anne Klibanski, MD, Chief, Neuroendocrine Unit, Massachusetts General Hospital Identifier: NCT01406444     History of Changes
Other Study ID Numbers: 2R01DK052625 ( U.S. NIH Grant/Contract )
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

Keywords provided by Anne Klibanski, MD, Massachusetts General Hospital:
Anorexia Nervosa
Bone density

Additional relevant MeSH terms:
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Risedronic Acid
Anorexia Nervosa
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Growth Substances