IGF-1 and Bone Loss in Women With Anorexia Nervosa
This study is currently recruiting participants.
Verified March 2013 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Anne Klibanski, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01406444
First received: July 26, 2011
Last updated: March 6, 2013
Last verified: March 2013
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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:
Drug Information available for:
Insulin-like growth factor I
Mecasermin
Risedronate sodium
Mecasermin rinfabate
U.S. FDA Resources
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
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: | March 6, 2013 |
| 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 Bone Diseases, Metabolic Osteoporosis Signs and Symptoms, Digestive Signs and Symptoms Eating Disorders Mental Disorders Bone Diseases Musculoskeletal Diseases |
Risedronic acid Etidronic Acid Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013