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

Phase 2

Completed

• Conditions: Anorexia Nervosa; Osteoporosis
• Interventions: Drug: Placebo; Drug: Teriparatide

• Registration Number: NCT00759772
• Lead Sponsor: Massachusetts General Hospital

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).

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Primary Completion: 2016-02-22
• Study Completion: 2016-02-22
• Results First Submitted: 2017-02-08
• Results First Submitted QC: 2017-02-08
• Results First Posted: 2017-03-28
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Teriparatide	Teriparatide	-

Primary Outcome Measures

Name	Time	Method
Percent Change in Lumbar Spine Bone Mineral Density	Baseline and 6 months	Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period)

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States