facts about the Bone Health in Female Runners Intervention Trial (B-FIT)
Many competitive women athletes experience
Menstrual irregularities include amenorrhea
(the absence of a menstrual period) and oligomenorrhea (infrequent
menstruation). Athletes may also experience hidden abnormalities such as
shortened luteal phase, and anovulatory cycles.
Menstrual irregularities reflect low
serum estrogen levels.
Estrogen is a key hormone in bone deposition
Women athletes with menstrual irregularities
are at increased risk for low bone mass and stress fractures.
Oral contraceptives contain estrogen
and regulate the menstrual cycle.
Estrogen replacement has been shown
to prevent bone loss in post-menopasual women and in pre-menopausal women
with medical conditions such as premature ovarian failure and hyperprolactinemia.
It is unknown if estrogen replacement
prevents bone loss in women athletes with menstrual irregularities, as
the hypothesis has never been tested.
This study is a randomized trial of
oral contraceptive use in 150 female cross country runners.
The study will test the hypothesis that
oral contraceptives reduce stress fracture incidence and prevent loss of
bone mass or increase bone mass among highly trained female athletes.
This study is important because it is
the first trial to test the efficacy of oral contraceptives as a bone health
intervention among women athletes.
Interested runners will be screened
for eligibility via phone interview or email.
Eligible athletes agreeing to participate
will visit one of the five clinical sites in the U.S. to be screened for
oral contraceptive use and to complete a baseline bone scan. They will
complete also complete a food questionnaire and a training questionnaire.
Athletes will be randomly assigned to
either the treatment group, which takes a oral contraceptive (Lo/Ovral)
containing 30 micrograms of estrogen, or to the control group, which takes
nothing. PLEASE NOTE: Participants cannot select their own group. B-FIT
will supply the oral contraceptive for the duration of the study
One year after the baseline bone scan,
athletes will complete the food and training questionnaires again and return
to the clinical site for a second bone scan.
Two years after the baseline bone scan
athletes will have their final bone scan and fill out the training and
food questionnaires again. At this time, the committment to B-FIT is fulfilled.
Throughout the two years of participation,
athletes will keep a menstrual calendar and will contact the B-FIT office
if a stress fracture is suspected or diagnosed.
Participants must be:
Female and between the ages of 18 -
Running competitively, approximately
30+ miles a week, competing in races a plus
Not currently taking oral contraceptives
or estrogen replacement
Willing to be randomized into either
treatment (oral contraceptive group) or control (no OC group)
Close to Stanford, U.C.L.A or N.Y.C.
(travel expenses reimbursed)
OR a student at Bowdoin, Cal Poly SLO,
Cal Poly Pomona, CalState Fresno, CalState Stanislaus, Connecticut College,
Dartmouth College, Lehigh University, Michigan State University, University
of Michigan, Oakland University, Monmouth College, Mount Holyoke College,
Santa Clara University, San Diego State University, Springfield College,
University of New Hampshire, University of Vermont, or Vassar College.
A test for bone density (DXA), usually
$200-$500, free to all participants
Body composition measurements
Running gifts including a subscription
to Running Times magazine
Reimbursed travel to and from the bone
The chance to participate in an important
women's health study and help the advancement of women's sports and female
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