Hormone Dynamics and Bone Mineral Density in Anorexia Ner... | NCT00556036

Studies
Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea

NCT00556036

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Sep 2, 2020Actual

Enrollment

61Actual

Phase

Not provided

Conditions

Anorexia Nervosa
Hypothalamic Amenorrhea
Obesity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Nov 7, 2007

First Submission Date that Met QC Criteria

Nov 7, 2007

First Posted Date

Nov 9, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2020

Last Update Posted Date

Sep 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Karen Klahr Miller, MD, Chief, Neuroendocrine Unit, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
National Institutes of Health (NIH)	NIH
Bioenvision	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Amenorrhea for at least three months (unless participating as healthy control)
Normal TSH or free thyroxine (free T4).

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

community sample and referrals by specialists

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne A Klibanski, MD	Massachusetts General Hospital	Principal Investigator
Karen K Miller, MD	Massachusetts General Hospital	Study Director
Erinne M Meenaghan, NP	Massachusetts General Hospital	Study Chair
Elizabeth A Lawson, MD	Massachusetts General Hospital	Study Director
David B Herzog, MD	Massachusetts General Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

Condition Browse Module

MeSH Terms

ID	Term
D000856	Anorexia Nervosa
D009765	Obesity
D050177	Overweight
D001835	Body Weight
D001851	Bone Diseases, Metabolic
D010024	Osteoporosis
D000568	Amenorrhea
D003863	Depression
D009043	Motor Activity

Ancestor Terms

ID	Term
D001068	Feeding and Eating Disorders
D001523	Mental Disorders
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided