The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa

NCT ID: NCT00759772

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2016-02-22

Brief Summary

Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa, or disordered eating. Women with decreased bone strength are more likely to suffer broken bones than women with normal bone strength.

We are investigating whether a hormone that is naturally produced by the human body -- parathyroid hormone (PTH) -- can help strengthen the bones of women with anorexia nervosa.

Detailed Description

Anorexia Nervosa affects 0.5-1% of college-age women in the US and is associated with a number of significant medical conditions including bone loss. A majority of women with anorexia nervosa have bone loss and 50% have bone mineral density measurements greater than 2 standard deviations below normative means. Bone loss in anorexia nervosa is characterized by a decrease in bone formation, therefore therapy with an anabolic agent may be an effective treatment approach. In a randomized, single-blinded, placebo-controlled trial, we will study the effects of parathyroid hormone on low bone mass in anorexia nervosa, specifically looking at the effects of parathyroid hormone on bone mineral density (primary outcome).

Conditions

Anorexia Nervosa; Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Teriparatide

Group Type: ACTIVE_COMPARATOR

Teriparatide

Intervention Type: DRUG

20 mcg sc daily for 6 months

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

sc daily for 6 months

Interventions

Placebo

sc daily for 6 months

Intervention Type: DRUG

Teriparatide

20 mcg sc daily for 6 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Anorexia Nervosa
• Women, age 30-70 years
• Osteoporosis or history of clinical fractures (spine, wrist, hip or ribs)

Exclusion Criteria

• Diseases known to affect bone metabolism
• Hyperparathyroidism
• Medications known to affect bone metabolism in last 12 weeks (or bisphosphonate use in last 1 year)
• Pregnant and/or breastfeeding
• Diabetes mellitus
• History of malignancy involving or affecting the bone, any active malignancy, and/or radiation therapy to the bone
• Fractures of a bone other than a finger or toe in last 1 year

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pouneh K. Fazeli, MD

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pouneh K Fazeli, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

829

Identifier Type: -

Identifier Source: org_study_id