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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||The Role of PTH in Low Bone Mass in Anorexia Nervosa|
- Bone metabolism [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
Teriparatide 20 mcg sc daily for 6 months
|Placebo Comparator: 2||
Placebo 20 mcg sc daily for 6 months
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759772
|Contact: Pouneh K Fazeli, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Pouneh K Fazeli, MD 617-726-1347 email@example.com|
|Principal Investigator:||Pouneh K Fazeli, MD||Massachusetts General Hospital|