Anorexia Nervosa, Osteoporosis
Conditions
Keywords
Anorexia Nervosa, Disordered Eating, Osteoporosis, Parathyroid Hormone, Bone
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).
Interventions
DRUGPlacebo
sc daily for 6 months
DRUGTeriparatide
20 mcg sc daily for 6 months
Sponsors
Eli Lilly and Company
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Teriparatide Teriparatide: Teriparatide 20 mcg sc daily for 6 months | 12 |
| Placebo Placebo: Placebo 20 mcg sc daily for 6 months | 11 |
| Total | 23 |
Baseline characteristics
| Characteristic | Teriparatide | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 47.6 years STANDARD_DEVIATION 9.6 | 47.1 years STANDARD_DEVIATION 7.6 | 47.3 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment United States | 12 participants | 11 participants | 23 participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 12 | 9 / 12 |
| serious Total, serious adverse events | 2 / 12 | 3 / 11 |
Outcome results
Primary
Percent Change in Lumbar Spine Bone Mineral Density
Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period)
Time frame: Baseline and 6 months
Population: All participants were included in analysis (intention to treat).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teriparatide | Percent Change in Lumbar Spine Bone Mineral Density | 5.6 percentage of change | Standard Error 1.3 |
| Placebo | Percent Change in Lumbar Spine Bone Mineral Density | 0.2 percentage of change | Standard Error 0.7 |
p-value: <0.01t-test, 2 sided