Project Title: Investigating the Influence of Menopause on Disease Progression in Women

Project Title: Investigating the influence of menopause on disease progression in women.

Principal Investigator: Tanuja Chitnis, MD

Co-investigators: Riley Bove, MD, Philip L De Jager, MD PhD, Alexander Musallam, Maria Houtchens

Principal contact person: Riley Bove, MD

Purpose (1-2 sentences):

To determine whether the endocrine transitions occurring at menopause are associated with altered clinical trajectory in women with MS.

Previously, we have found that women with MS onset after the age of 50 have a clinical trajectory that is more similar to that of men, than do women with MS onset before age 50 (i.e., less sex-specific difference in clinical trajectory in older cohort).

Estradiol is felt to be both proinflammatory, as well as neuroprotective.

Therefore, with menopause, we hypothesize to find:

-- Fewer relapses or new lesions

-- More rapid progression of disability (EDSS) and of QOL scores.

Study Design (1-2 sentences):

1. Using the reproductive questionnaire that has been approved for SUMMIT, we will investigate age at natural menopause for women with MS, which is unknown. We will use survival analysis (excluding prior chemotherapy, oophorectomy or XRT).

2. For all women who are postmenopausal, we will compare disease trajectory (EDSS, relapse rate, BPF, T2LV and QOL measures) before and after the final menstrual period.

-- Men will be included in the analysis, controlling for sex, disease type and disease duration, to control for the effects of age on disease course.

-- We will also examine the potential protective effect of hormone replacement therapy (HRT) as an exploratory analysis.

Estimated Sample size (if known): All CLIMB females completing the reproductive questionnaire.

Data Requested (check all that apply):

Patient population (check all that apply):

_X_CLIMB patients

__Global Clinic population

__Control subjects

Clinical data (email sent to Tanuja Chitnis):

_X_demographic information (age, gender, race)

_X_disease duration

_X_disease category

_X_disease course subtype

_X_ relapse information

X__EDSS

X__medication information

X__McDonald criteria fulfillment

__other (list ___)

Cognitive and Psychosocial data(email sent to Bonnie Glanz):

X__SDMT

__BRB

__TONI-3

X__CES-D

__MOS Social Support Survey

X__MFIS

__MSQOL54

_X_other (SF36)

MRI data (email sent to Charles Guttmann and Svetlana Egorova):

X__T2LV

X__BPF

__T1 black holes

X__CEL

__GMF

__WMF

__other (list ___)

Immunology data (email sent to Samia Khoury and Pia Kivasakk):

__flow cytometry data

__other (list ___)

Genetics data (email sent to Phil De Jager):

__tissue typing

__common risk alleles by SNP analysis

__Affymetrix RNA data

__other (list _____)

Samples (email sent to Samia Khoury and Pia Kivasakk):

__serum

__DNA

__cells

__other (list ___)

Statistical support request (email sent to Brian Healy):

X__Brian Healy

__other (list____)

IRB for Project: CLIMB/SUMMIT

Pending___

If approved list:

Protocol #:

Protocol Title:

Expiration date:

Upload approval (option to attach file)

Data use: (check all that apply)

X__preliminary data for a grant proposal

X__meeting abstract

X__manuscript

__other (list ___)

Request initiated on: _12_/_5_/_2012_

Approved on: __/__/__