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

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Osteoporosis; Anorexia Nervosa

Treatments: Drug: Placebo; Drug: Teriparatide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00759772

829

Details and patient eligibility

About

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.

Full 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).

Enrollment: 23 patients

Sex: Female

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups, including a placebo group

Teriparatide

Active Comparator group

Treatment:

Drug: Teriparatide

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo