Expired Study
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Boston, Massachusetts 02114


Purpose:

Women with Anorexia Nervosa have been found to have low bone density. The study will determine whether administration of low doses of a natural hormone, testosterone and/or risedronate, a medication to help prevent bone breakdown will improve or prevent bone loss in this condition.


Study summary:

II. SPECIFIC AIMS Severe osteopenia is a prevalent complication of anorexia nervosa (AN), affecting over half of all women with this disease. Loss of 25-50% of total bone mass occurs frequently and is often permanent. Although anorexia nervosa affects from 0.5-1.0% of college age women, no successful therapeutic interventions have been developed for osteoporosis in this population. Bone loss in anorexia nervosa is characterized by reduced bone formation coupled with increased bone resorption. Anorexia nervosa results in a deficiency of testosterone. Testosterone administration reduces bone resorption and data suggest that low-dose testosterone replacement therapy can increase surrogate markers of bone formation. Bisphosphonates are now well established to decrease bone resorption and improve bone density in severely osteopenic postmenopausal women. However, there are few data regarding the use of this antiresorptive therapy in women with severe pre-menopausal bone loss. Our preliminary data demonstrate that administration of a bisphosphonate decreases bone resorption and increases bone mass in women with AN after 6 and 9 months. These are the first data to demonstrate a striking increase in bone density in such women. We will test the hypothesis that a combined strategy to increase bone formation and decrease bone resorption by combining testosterone with a bisphosphonate will increase bone mass in anorexia nervosa. The following hypotheses will be tested: Specific Aim 1. Testosterone, a nutritionally dependent bone trophic factor, is a critical determinant of decreased bone formation in anorexia nervosa, and administration of physiologic testosterone will increase bone formation and lean body mass in this disease We will investigate in women with anorexia nervosa whether: A. Bone formation is reduced in association with low serum testosterone B. Testosterone deficiency is due to a combination of ovarian and adrenal defects resulting from undernutrition C. Testosterone administration reverses testosterone deficiency leading to an acute and sustained increase in bone formation and a decrease in bone resorption D. Administration of physiologic testosterone replacement stimulates increases in IGF-I levels in women with anorexia nervosa, a mechanism for increased bone formation and bone density E. Administration of physiologic testosterone replacement increases lean body mass, a major determinant of bone density Specific Aim 2. Long-term (12 months) physiologic testosterone administration combined with a bisphosphonate increases bone density by a dual anabolic and anti-resorptive strategy We will investigate in women with anorexia nervosa whether: A. Physiologic testosterone administration increases bone density B. Administration of a bisphosphonate decreases the excessive state of bone resorption and increases bone density C. Co-administration of physiologic testosterone replacement and a bisphosphonate increases bone density to a greater degree than testosterone or a bisphosphonate alone by increasing bone formation and decreasing bone resorption


Criteria:

Inclusion Criteria: - Anorexia Nervosa, - Over 18, - Female, - Decreased bone density Exclusion Criteria: - Medications to increase bone density


Study is Available At:


Original ID:

5 R01 DK052625 (completed


NCT ID:

NCT00089843


Secondary ID:


Study Acronym:


Brief Title:

Bone Loss in Women With Anorexia Nervosa


Official Title:

IGF-1 and Bone Loss in Women Anorexia Nervosa


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

76


Enrollment Type:

Actual


Overall Contact Information

Official Name:Anne Klibanski, M.D.
Principal Investigator
Massachusetts General Hospital

Study Dates

Start Date:June 2003
Completion Date:April 2008
Completion Type:Actual
Primary Completion Date:April 2008
Primary Completion Type:Actual
Verification Date:March 2010
Last Changed Date:March 1, 2010
First Received Date:August 16, 2004

Study Outcomes

Outcome Type:Primary Outcome
Measure:Bone density
Time Frame:6 and 12 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Bone markers
Time Frame:6 and 12 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Testosterone
Description:Testosterone patch 150mcg daily
Arm Name:2
Other Name:Intrinsa
Intervention Type:Drug
Name:Risedronate
Description:Risedronate 35mg PO one time weekly
Arm Name:3
Other Name:Actonel

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:2
Description:Placebo Actonel and active testosterone patch
Study Arm Type:Active Comparator
Arm Name:3
Description:Active Actonel and Active Testosterone patch
Study Arm Type:Active Comparator
Arm Name:4
Description:Active Actonel and Placebo Testosterone
Study Arm Type:No Intervention
Arm Name:1
Description:Placebo testosterone patch and placebo actonel

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Center for Research Resources (NCRR)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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