A Phase II Prospective Pilot Study Evaluating Efficacy of Intravenous Zoledronic Acid Prophylaxis for Prevention of Aromatase Inhibitor Associated Musculoskeletal Symptoms: ZAP-AIMSS Trial
PRIMARY OBJECTIVES:
I. Percentage of women experiencing aromatase inhibitor associated musculoskeletal symptoms
(AIMSS) at 1, 3, 6, and 12 months after bisphosphonate therapy, as compared to historical
controls.
II. Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score and 1, 3, 6
and 12 months, from baseline, among those receiving bisphosphonate, as compared to
historical controls.
SECONDARY OBJECTIVES:
I. Change in pain scores on visual analog scale (VAS) at 1, 3, 6 and 12 months, from
baseline, compared to historical controls.
II. Change in amount and/or frequency of oral analgesic use at 1, 3, 6 and 12 months from
baseline among those receiving bisphosphonate therapy, as compared to historical controls.
III. Number of patients who discontinue or change aromatase inhibitor (AI) therapy.
IV. Change in menopausal symptoms (NSABP-revised), hot flash frequency (HFRDIS),sleep
quality (PSQI), depression score (CESD) and overall quality of life (EuroQOL) in patients at
1, 3, 6 and 12 months from baseline, among those receiving bisphosphonate therapy, as
compared to historical controls.
V. Changes in plasma estrogen concentrations at 1, 3, 6 and 12 months from baseline, among
those receiving bisphosphonate therapy, as compared to historical controls.
VI. Change in bone mineral density (DEXA scan) at 12 months from baseline, among those
receiving bisphosphonate therapy, as compared to historical controls.
VII. Change in bone turn over markers (serum-C telopeptide, bone-specific alkaline
phosphatase, osteocalcin and urinary N-telopeptide) at 1, 3, 6 and 12 months from baseline,
among those receiving bisphosphonate therapy, as compared to historical controls.
VIII. Change in inflammatory markers (ESR, CRP, IL-1, IL-6, IL-8) at 1, 3, 6 and 12 months
from baseline, among those receiving bisphosphonate therapy, as compared to historical
controls.
OUTLINE: Patients receive zoledronic acid intravenously (IV) at months 1 and 6. Beginning 14
days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12
months in the absence of disease progression or unacceptable toxicity.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Frequency of women with aromatase inhibitor associated musculoskeletal symptoms (AIMSS)
12 months
No
Vered Stearns
Principal Investigator
Johns Hopkins University
United States: Institutional Review Board
J1022
NCT01194440
February 2011
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |