ABSTRACT
The purpose of the study was to evaluate the efficacy and safety of vitamin D3 at 4000 IU/day as a treatment option for aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) when compared with the usual care dose of 600 IU D3. We conducted a single site randomized, double-blind, phase 3 clinical trial in women with AIMSS comparing change in symptoms, reproductive hormones and AI pharmacokinetics. Postmenopausal women ≥18 years with stages I-IIIA breast cancer, taking AI and experiencing AIMSS [breast cancer prevention trial symptom scale-musculoskeletal (BCPT-MS) subscale ≥1.5] were admitted. Following randomization, 116 patients had a run-in period of 1 month on 600 IU D3, then began the randomized assignment to either 600 IU D3 (n = 56) or 4000 IU D3 (n = 57) daily for 6 months. The primary endpoint was a change in AIMSS from baseline (after 1 month run-in) on the BCPT-MS (general MS pain, joint pain, muscle stiffness, range for each question: 0 = not at all to 4 = extremely). Groups had no statistically significant differences demographically or clinically. There were no discernable differences between the randomly allocated treatment groups at 6 months in measures of AIMSS, pharmacokinetics of anastrozole and letrozole, serum levels of reproductive hormones, or adverse events. We found no significant changes in AIMSS measures between women who took 4000 IU D3 daily compared with 600 IU D3. The 4000 IU D3 did not adversely affect reproductive hormone levels or the steady state pharmacokinetics of anastrozole or letrozole. In both groups, serum 25(OH)D remained in the recommended range for bone health (≥30 ng/mL) and safety (<50 ng/mL).
Subject(s)
Aromatase Inhibitors/adverse effects , Arthralgia/drug therapy , Breast Neoplasms/drug therapy , Cholecalciferol/administration & dosage , Musculoskeletal Diseases/drug therapy , Adult , Aged , Anastrozole , Antineoplastic Agents, Hormonal , Aromatase Inhibitors/administration & dosage , Arthralgia/chemically induced , Arthralgia/physiopathology , Bone Density/drug effects , Breast Neoplasms/blood , Breast Neoplasms/physiopathology , Cholecalciferol/adverse effects , Double-Blind Method , Drug-Related Side Effects and Adverse Reactions/drug therapy , Drug-Related Side Effects and Adverse Reactions/physiopathology , Female , Humans , Letrozole , Middle Aged , Musculoskeletal Diseases/chemically induced , Musculoskeletal Diseases/physiopathology , Nitriles/administration & dosage , Triazoles/administration & dosage , Vitamin D/bloodABSTRACT
We assess gender differences in HIV prevention knowledge, attitudes and practices with a focus on cultural, sociological, and economic variables. A randomized cross-sectional study was used in order to achieve high participation and broad comparative assessment. An eight-page questionnaire was administered to 933 randomly selected students at the University of Zimbabwe. Survey items addressed sexual decision-making, condom use, limiting sexual partners, cultural power dynamics and access to HIV testing. We found marked gender differences with men reporting beliefs of entitlement to dominate women, an assumed leadership in decision-making concerning condom use and an attitude that when a woman says "no" to sex, really, "it depends." Women acknowledged gender-based cultural attitudes but are much more likely to support women's rights to sexual expression. A multi-faceted approach to gender equity training is needed to challenge men and women to change attitudes and increase social awareness that respects cultural traditions while still inspiring both men and women to champion justice and equality between genders.