Osteoporosis Clinical Trial
Official title:
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 Removal of Both Ovaries
This randomized phase II trial is studying zoledronate to see how well it works compared to observation in maintaining bone mineral density in patients who are undergoing surgery to remove both ovaries. Zoledronate may prevent bone loss in patients who are undergoing surgery to remove the ovaries.
PRIMARY OBJECTIVE:
I. Compare the effect of zoledronate vs observation on bone loss associated with surgery (at
a minimum, any surgical procedure that results in removal of both ovaries) in patients
undergoing excision of both ovaries.
SECONDARY OBJECTIVE:
I. Compare the change in bone mineral density of the bilateral hip in patients treated with
these regimens.
TERTIARY OBJECTIVE:
I. Compare the effect of zoledronate vs observation on biochemical markers of bone resorption
and bone formation (N-telopeptide and bone specific alkaline phosphatase) during 1 year of
treatment.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
arms.
All patients undergo surgery, with removal of both ovaries, in month 1. All patients are
requested to take calcium supplements twice daily and a multivitamin containing vitamin D
once daily beginning in month 1 and continuing for up to 18 months.
ARM I: Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes
once in months 3, 9, and 15.
ARM II: Patients are observed for 18 months after surgery.
In both arms, patients complete physical activity questionnaires at baseline and in months 3,
9, 15, and 18. Patients undergo bone mineral density test of lumbar spine and total hip at
baseline and in months 9 and 18. Patients also undergo blood collection at baseline and
periodically during the study for biomarker studies.
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