A Phase II Randomized Study of the Effect
of Zoledronic Acid Versus Observation on Bone Mineral Density
of the Lumbar Spine in Women who Elect to Undergo Surgery
That Results in the Removal of Both Ovaries
Can zoledronic acid (Zometa®) prevent loss of bone mineral
in women who have their ovaries removed to reduce their risk
of or ovarian cancer?
What is this clinical trial all about?
Clinical trials are research studies in
which people help doctors find ways to improve health. Each study
tries to answer scientific questions and to find better ways to
prevent, diagnose or treat diseases and their side effects. The
purpose of this study is to look at the effects of zoledronic acid
on preventing bone loss in women who undergo early menopause due
to surgical removal of the ovaries.
Women who choose to have surgical removal of their ovaries are
invited to join this study. Removal of the ovaries in women who are
still having menstrual periods results in periods stopping earlier
than they normally would, also called premature menopause. The ovaries
produce estrogen, which helps to maintain bone mineral density, or
bone strength. Low bone mineral density is also called osteoporosis.
Women who undergo premature menopause are at increased risk for osteoporosis.
Zometa® is in class of drugs called bisphosphonates, which
are often used in for prevention and treatment of osteoporosis.
Zometa is also used in the treatment of bone disease and high blood
calcium levels associated with some cancers. It is given as an
intravenous (IV) infusion.
What will happen in this study?
Participants may enroll in the study prior to,
or up to 8 weeks after having surgery to remove their ovaries.
If you participate in this study, you will be “randomized” into
one of the study groups described below. Randomization means that
you are put into a group by chance. A computer picks which group
you will be in. You will have an equal chance of being placed in
either group. Neither you, your doctor, nor the researchers will
be able to choose which group you are in.
- Treatment Group: If you
are assigned to the treatment group, you will receive an injection
of zoledronic acid (Zometa®) every six months for a total
of three treatments. The first injection will be given two to
three months after you undergo surgical removal of both ovaries.
Zoledronic acid is given as an injection into your vein over
about 15 minutes. You will also be asked to give blood samples,
undergo a bone density test, and complete questionnaires at the
time of enrollment and periodically throughout the 18 month study
- Observation Group: If you are
assigned to the observation group, you will not receive Zometa, but
will be asked to give blood samples, undergo a bone density test,
and complete questionnaires at the time of enrollment and periodically
throughout the 18 month study period. Participants in both the Treatment
Group and the Observation Group will be asked to take daily calcium
and vitamin D supplements by mouth, to engage in regular, weight-bearing
exercise, and to avoid tobacco smoking. This is the current recommended
treatment approach for women who are at increased risk of osteoporosis.