Anorexia NervosaPhase 21180NCT02475265
Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa
A Phase 2 study testing estradiol 0.045 mg/levonorgestrel 0.015mg in people with Anorexia Nervosa and Osteoporosis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa. Women with decreased bone strength are more likely to suffer broken bones than women with normal bone strength. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Anorexia Nervosa, Osteoporosis
- What is being tested?
- estradiol 0.045 mg/levonorgestrel 0.015mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 30 Jul 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female; ages 25-50 years
- Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) psychiatric criteria for AN, including <85% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables, and amenorrhea
- T-score of < -1.5 at spine or hip
- Treatment team or treatment professional in place for clinical treatment/monitoring during the study
Who cannot join
- Diseases known to affect bone metabolism, including untreated thyroid dysfunction, vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency
- Personal history of venous or arterial clot
- History of stroke or myocardial infarction
- History of migraine headaches
- History of hypercoagulable disorder
- Personal history or history of a first-degree relative with breast cancer
Show all 13Show fewer
- History of hereditary angioedema
- Any medication known to affect bone metabolism, including systemic glucocorticoids within three months of the baseline visit, depot medroxyprogesterone within 6 months of the baseline visit, oral bisphosphonates within one year of the baseline visit or intravenous (IV) bisphosphonates within three years of the baseline visit
- Bone fracture within the prior 12 months
- Serum potassium < 3.0 meq/L or serum alanine aminotransferase (ALT) > 3 times the upper limit of normal
- Fasting serum triglyceride level > 150 mg/dL
- Pregnant or breastfeeding
- Active substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa. Women with decreased bone strength are more likely to suffer broken bones than women with normal bone strength.
This study will investigate whether the use of transdermal estrogen can improve bone mineral density (BMD) and bone microarchitecture in women with anorexia nervosa anorexia nervosa when used for 6 months.
Read the detailed description
Anorexia nervosa (AN) is a prevalent psychiatric disorder affecting up to 1% of college-aged women in the US and an increasing number of women over 30 years of age. Among the many medical co-morbidities associated with AN, the most common is significant bone loss, which can persist despite weight recovery. Nearly 50% of women with AN have osteopenia with an additional 30% meeting WHO criteria for osteoporosis. Importantly, this severe bone loss is associated with an increased fracture risk. Nearly 30% of women with AN report a history of a fracture and a prospective study demonstrated a 7-fold increased risk of fracture in women with AN compared to age-matched controls. Because AN is a chronic disease that can persist despite psychiatric and nutritional counseling, the bone loss and increased fracture risk can persist and lead to lifelong morbidity. Therefore, finding a treatment for bone loss associated with AN is of critical importance.
This 6 month open-label study will investigate in women (ages 25 to 50 years old) with AN whether treatment with transdermal estrogen replacement will increase bone mineral density (BMD), improve parameters of bone microarchitecture as assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT), and improve bone strength as estimated by microfinite element analysis.
- Conditions
- Anorexia Nervosa, Osteoporosis
- Being tested
- estradiol 0.045 mg/levonorgestrel 0.015mg
- Keywords
- Anorexia Nervosa, Osteoporosis, Eating Disorder, Disordered Eating, Estrogen, Bone
- Medical subject headings
- Anorexia Nervosa, Osteoporosis, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estradiol 0.045 mg/levonorgestrel 0.015mgDrug
Also called Climara Pro transdermal patch
| Study group | Role | What they receive |
|---|---|---|
| estradiol 0.045mg/levonorgestrel 0.015mg | Experimental | 6 months of estradiol 0.045mg/levonorgestrel 0.015mg (once weekly patch). Receives: Drug: estradiol 0.045 mg/levonorgestrel 0.015mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine by Dual Energy X-ray Absorptiometry (DXA)
Percent change in lumbar spine bone mineral density after six-months. Lumbar spine bone mineral density measured by dual energy x-ray absorptiometry.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion27 Jun 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pouneh K. Fazeli, MD, Massachusetts General Hospital
- Investigators
- Pouneh K Fazeli, MD, Principal investigator, MGH/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475265
- Sponsor's protocol ID
- 2015P000463
- Other IDs
- R03DK106410
- Acronym
- 1180
- Status last verified
- Jul 2019
- First submitted
- 10 Jun 2015
- Last updated
- 22 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT02475265
- Acronym / sponsor ID
- 1180 / 2015P000463
- Conditions
- Anorexia Nervosa, Osteoporosis
- Keywords
- Anorexia Nervosa, Osteoporosis, Eating Disorder, Disordered Eating, Estrogen, Bone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2015 (actual)
- Primary completion
- 27 Jun 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Posted 22 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa. Women with decreased bone strength are more likely to suffer broken bones than women with normal bone strength.
This study will investigate whether the use of transdermal estrogen can improve bone mineral density (BMD) and bone microarchitecture in women with anorexia nervosa anorexia nervosa when used for 6 months.
Detailed description
Anorexia nervosa (AN) is a prevalent psychiatric disorder affecting up to 1% of college-aged women in the US and an increasing number of women over 30 years of age. Among the many medical co-morbidities associated with AN, the most common is significant bone loss, which can persist despite weight recovery. Nearly 50% of women with AN have osteopenia with an additional 30% meeting WHO criteria for osteoporosis. Importantly, this severe bone loss is associated with an increased fracture risk. Nearly 30% of women with AN report a history of a fracture and a prospective study demonstrated a 7-fold increased risk of fracture in women with AN compared to age-matched controls. Because AN is a chronic disease that can persist despite psychiatric and nutritional counseling, the bone loss and increased fracture risk can persist and lead to lifelong morbidity. Therefore, finding a treatment for bone loss associated with AN is of critical importance.
This 6 month open-label study will investigate in women (ages 25 to 50 years old) with AN whether treatment with transdermal estrogen replacement will increase bone mineral density (BMD), improve parameters of bone microarchitecture as assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT), and improve bone strength as estimated by microfinite element analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| estradiol 0.045mg/levonorgestrel 0.015mg | Experimental | Drug: estradiol 0.045 mg/levonorgestrel 0.015mg6 months of estradiol 0.045mg/levonorgestrel 0.015mg (once weekly patch). |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female; ages 25-50 years
- Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) psychiatric criteria for AN, including <85% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables, and amenorrhea
- T-score of < -1.5 at spine or hip
- Treatment team or treatment professional in place for clinical treatment/monitoring during the study
Key exclusion criteria (13 listed)
- Diseases known to affect bone metabolism, including untreated thyroid dysfunction, vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency
- Personal history of venous or arterial clot
- History of stroke or myocardial infarction
- History of migraine headaches
- History of hypercoagulable disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estradiol 0.045 mg/levonorgestrel 0.015mgAlso: Climara Pro transdermal patch | Drug | estradiol 0.045mg/levonorgestrel 0.015mg |
Primary outcome
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine by Dual Energy X-ray Absorptiometry (DXA)
Time frame: 6 months
Percent change in lumbar spine bone mineral density after six-months. Lumbar spine bone mineral density measured by dual energy x-ray absorptiometry.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pouneh K Fazeli, MD principal investigator
MGH/Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing estradiol 0.045 mg/levonorgestrel 0.015mg in people with Anorexia Nervosa and Osteoporosis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine by Dual Energy X-ray Absorptiometry (DXA) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.