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

Osteoporosis Clinical Trial

Official title:

The Role of PTH in Low Bone Mass in Anorexia Nervosa

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00759772
• Other study ID #: 829
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 24, 2008
• Last updated: January 9, 2017
• Start date: September 2008
• Est. completion date: February 2017

Study information

• Verified date: October 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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, bone turnover markers and bone microarchitecture.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Osteoporosis

Intervention

Drug:
• Teriparatide
Teriparatide 20 mcg sc daily for 6 months
• Placebo
Placebo 20 mcg sc daily for 6 months

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone metabolism		6 months	No