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Completed

NCT Number: NCT00759772

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

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.

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Key information

Conditions

Anorexia Nervosa Bone Diseases Bone Diseases, Metabolic Feeding and Eating Disorders Mental Disorders Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

30 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

sc daily for 6 months

Teriparatide

Drug

20 mcg sc daily for 6 months

Primary outcomes

  1. Percent Change in Lumbar Spine Bone Mineral Density

    Time frame: Baseline and 6 months

    Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

The Role of PTH in Low Bone Mass in Anorexia Nervosa

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Sep 25, 2008
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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