Anorexia NervosaNCT00556036
Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea
An observational study of Anorexia Nervosa and Hypothalamic Amenorrhea, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the hormone dynamics in women with anorexia nervosa and hypothalamic amenorrhea is related to bone loss in those populations. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Hypothalamic Amenorrhea, Obesity
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: community sample and referrals by specialists
Who may be able to join
- Amenorrhea for at least three months (unless participating as healthy control)
- Normal TSH or free thyroxine (free T4).
Who cannot join
- A condition known to affect bone metabolism, including Cushing's syndrome or renal failure, with the exception of bone fracture.
- Any medication known to affect bone metabolism within 3 months of the study, including estrogen and progestins. Patients receiving depot medroxyprogesterone (Depo-Provera) will be excluded from participating for 6 months after their last injection.
- Pregnant and/or breastfeeding.
- Diabetes mellitus.
- Active substance abuse, including alcohol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to determine whether the hormone dynamics in women with anorexia nervosa and hypothalamic amenorrhea is related to bone loss in those populations.
- Conditions
- Anorexia Nervosa, Hypothalamic Amenorrhea, Obesity
- Keywords
- healthy, overweight, obese, anorexia nervosa, weight, cortisol, hormone, bone density, bone, osteopenia, osteoporosis, amenorrhea, menses, irregular, stress, depression, exercise, diet
- Medical subject headings
- Anorexia Nervosa, Obesity, Overweight, Body Weight, Bone Diseases, Metabolic, Osteoporosis, Amenorrhea, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | lean healthy women, age 18-45 | |
| 2 | overweight healthy women, age 18-45 | |
| 3 | women with hypothalamic amenorrhea (have not had a period in three months), age 18-45 | |
| 4 | women with anorexia nervosa, age 18-45 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startMar 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Bioenvision
- Responsible party
- Principal investigator, Karen Klahr Miller, MD, Massachusetts General Hospital
- Investigators
- Anne A Klibanski, MD, Principal investigator, Massachusetts General HospitalKaren K Miller, MD, Study director, Massachusetts General HospitalErinne M Meenaghan, NP, Study chair, Massachusetts General HospitalElizabeth A Lawson, MD, Study director, Massachusetts General HospitalDavid B Herzog, MD, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556036
- Sponsor's protocol ID
- 2003p-000549
- Status last verified
- Aug 2020
- First submitted
- 7 Nov 2007
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea
- ClinicalTrials.gov ID
- NCT00556036
- Acronym / sponsor ID
- 2003p-000549
- Conditions
- Anorexia Nervosa, Hypothalamic Amenorrhea, Obesity
- Keywords
- healthy, overweight, obese, anorexia nervosa, weight, cortisol, hormone, bone density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Bioenvision
- Study start
- Mar 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 9 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the hormone dynamics in women with anorexia nervosa and hypothalamic amenorrhea is related to bone loss in those populations.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –lean healthy women, age 18-45 |
| 2 | – | –overweight healthy women, age 18-45 |
| 3 | – | –women with hypothalamic amenorrhea (have not had a period in three months), age 18-45 |
| 4 | – | –women with anorexia nervosa, age 18-45 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- community sample and referrals by specialists
Key inclusion criteria (2 listed)
- Amenorrhea for at least three months (unless participating as healthy control)
- Normal TSH or free thyroxine (free T4).
Key exclusion criteria (5 listed)
- A condition known to affect bone metabolism, including Cushing's syndrome or renal failure, with the exception of bone fracture.
- Any medication known to affect bone metabolism within 3 months of the study, including estrogen and progestins. Patients receiving depot medroxyprogesterone (Depo-Provera) will be excluded from participating for 6 months after their last injection.
- Pregnant and/or breastfeeding.
- Diabetes mellitus.
- Active substance abuse, including alcohol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
Related trials for Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
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.
Anne A Klibanski, MD principal investigator
Massachusetts General Hospital
Karen K Miller, MD study director
Massachusetts General Hospital
Erinne M Meenaghan, NP study chair
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Hypothalamic Amenorrhea, 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 2 inclusion and 5 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 2 Sep 2020. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 2 Sep 2020.