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IGF-1 and Bone Loss in Women With Anorexia Nervosa

Primary Purpose

Anorexia Nervosa, Osteopenia, Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rhIGF-1
Risedronate
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia Nervosa, Osteopenia, Osteoporosis, Bone density

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

rhIGF-1 followed by Risedronate

Risedronate

Placebo

Arm Description

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

Risedronate 35mg PO once weekly for 12 months

Placebo for 12 months

Outcomes

Primary Outcome Measures

Postero-anterior Spine Bone Mineral Density by DXA
Postero-anterior spine bone mineral density by dual-energy X-ray absorptiometry

Secondary Outcome Measures

Lateral Spine Bone Mineral Density by DXA
Lateral spine bone mineral density by dual-energy X-ray absorptiometry

Full Information

First Posted
July 26, 2011
Last Updated
July 6, 2020
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01406444
Brief Title
IGF-1 and Bone Loss in Women With Anorexia Nervosa
Official Title
IGF-1 and Bone Loss in Women With Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Osteopenia, Osteoporosis
Keywords
Anorexia Nervosa, Osteopenia, Osteoporosis, Bone density

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rhIGF-1 followed by Risedronate
Arm Type
Active Comparator
Arm Description
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
Arm Title
Risedronate
Arm Type
Active Comparator
Arm Description
Risedronate 35mg PO once weekly for 12 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 12 months
Intervention Type
Drug
Intervention Name(s)
rhIGF-1
Other Intervention Name(s)
Increlex
Intervention Description
Study participants will be started at a dose of 30 mcg/kg BID and will be titrated.
Intervention Type
Drug
Intervention Name(s)
Risedronate
Other Intervention Name(s)
Actonel
Intervention Description
Risedronate 35mg PO one time weekly
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo injections 30 mcg/kg BID, Placebo tablet PO once weekly
Primary Outcome Measure Information:
Title
Postero-anterior Spine Bone Mineral Density by DXA
Description
Postero-anterior spine bone mineral density by dual-energy X-ray absorptiometry
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Lateral Spine Bone Mineral Density by DXA
Description
Lateral spine bone mineral density by dual-energy X-ray absorptiometry
Time Frame
12 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Klibanski, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erinne Meenaghan, NP
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karen Miller, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

IGF-1 and Bone Loss in Women With Anorexia Nervosa

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