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Objective: This study aimed to investigate the effectiveness, tolerability and application of estradiol metered-dose transdermal spray (EMDTS) in postmenopausal women during real-world use. Methods: This was a prospective, non-interventional, multicenter, observational phase IV cohort study. The Menopause Rating Scale II (MRS II) was used to assess symptoms and clinical response. Safety was assessed by the occurrence of adverse events and adverse drug reactions (ADRs). Results: A total of 451 postmenopausal women were enrolled at 52 gynecological practices across Germany; 383 patients were evaluated for effectiveness and 430 patients for safety. Mean age was 54.3 ± 7.4 years. In total, 228 patients (59.5%) received EMDTS monotherapy and 155 patients (40.5%) received EMDTS plus progestogens. Significant improvements (p < 0.0001) from baseline in symptom severity were recorded for all 11 items of the MRS II at 3, 6 and 12 months of treatment. At 12 months, 81.4% of patients reported improvement in hot flushes/sweating. At final visit, 73% of patients and 77% of physicians were 'satisfied/very pleased' with EMDTS. Most common ADRs were headache (n = 6), nausea (n = 4), dizziness (n = 4) and pruritus (n = 3). Conclusions: EMDTS is an effective, well tolerated and easily applied hormone replacement therapy for women experiencing postmenopausal symptoms. [ABSTRACT FROM AUTHOR]

Selective estrogen receptor modulators (SERMs), which exhibit estrogen receptor agonist or antagonist activity based on the target tissue, have evolved through multiple generations for the prevention and/or treatment of postmenopausal osteoporosis. An ideal SERM would protect bone without stimulating the breast or endometrium. Raloxifene, lasofoxifene, and bazedoxifene have demonstrated unique preclinical profiles. Raloxifene, lasofoxifene, and bazedoxifene have shown significant reduction in the risk of vertebral fracture and improvement in bone mineral density versus placebo in postmenopausal women with osteoporosis. Raloxifene has been shown to reduce the risk of non-vertebral fractures in women with severe prevalent fractures at baseline. Lasofoxifene 0.5 mg, but not lasofoxifene 0.25 mg, has shown reduction in the incidence of non-vertebral fractures. Bazedoxifene 20 mg has been associated with a significant reduction in the risk of non-vertebral fracture versus placebo and raloxifene 60 mg in women at higher baseline fracture risk. Neither raloxifene, lasofoxifene, nor bazedoxifene has shown an increase in the incidence of endometrial hyperplasia or carcinoma. All SERMs have been associated with increased venous thromboembolic events and hot flushes. SERMs are effective alternatives for women who cannot tolerate or are unwilling to take bisphosphonates and may be appropriate for women at higher risk of fracture, particularly younger women who expect to remain on therapy for many years and are concerned about the long-term safety of bisphosphonates. [ABSTRACT FROM AUTHOR]

Objectives Dual-energy X-ray absorptiometry (DXA) is the gold standard for assessment of bone mineral density, an important risk factor for osteoporotic fractures. Recent reports suggest that quantitative ultrasonometry (QUS) is able to predict fractures; however, only limited data in women with hip fractures are available. Methods We examined 91 postmenopausal women who had sustained an osteoporosis-related hip fracture within the past 7 days using DXA and six different QUS devices and compared them with 91 healthy age-matched controls. Results Femoral neck (FN), total hip (TH) and lumbar spine (LS) T-scores were lower in women with hip fractures compared to matched controls: − 2.38 vs. − 1.64 ( p < 0.001), − 2.36 vs. − 1.44 ( p < 0.001) and − 2.05 vs. − 1.50 ( p = 0.41), respectively. The T-scores of the Achilles, Sahara, InSight and Omnisence QUS devices were also lower in patients with hip fractures compared to matched controls: − 3.20 vs. − 2.36 ( p < 0.001), − 2.196 vs. − 1.761 ( p = 0.005), − 2.631 vs. − 1.849 ( p < 0.001), − 3.707 vs. − 3.030 ( p = 0.032), respectively. However, the T-scores of the DBM and QUS-2 did not differ between the two groups: − 4.543 vs. − 4.324 ( p = 0.352) and − 1.7 vs. − 2.0 ( p = 0.465), respectively. Compared to DXA (hip), the odds ratios of the Achilles, InSight and Sahara were comparable, while the odds ratios of the DBM, Omnisence and QUS-2 were significantly lower ( p ≤ 0.05). Conclusions Compared to DXA, the Achilles, Sahara and InSight QUS devices showed similar hip fracture discrimination while the DBM, Omnisence and QUS-2 did not. Therefore, some QUS devices are able to identify a clinically meaningful risk factor in women at high risk of hip fracture. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to investigate the influence of anastrozole on serum hormone levels in postmenopausal women with hormone receptor-positive breast cancer. Methods We prospectively determined serum levels of estradiol, testosterone, dehydroepiandrosterone sulfate (DHEAS), sex hormone binding globulin (SHBG), follicle stimulating hormone (FSH) and luteinizing hormone (LH) at screening, as well as after 12 and 24 months of treatment and studied the associations with markers of bone turnover and bone mineral density (BMD). Results Altogether, a full set of hormone levels was available for 70 patients. Anastrozole treatment led to decreases of 92.1% for estradiol and 11.1% for LH over the observation period ( p < 0.001). Conversely, FSH, DHEAS and testosterone concentrations increased by 5.9%, 33.3% and 50%, respectively ( p < 0.001). SHBG levels remained stable during the 24 months of treatment ( p = 0.355). There were modest associations between FSH, SHBG, CrossLaps and N-terminal propeptide of human procollagen type I ( p < 0.05). Moreover, SHBG correlated positively with the BMD of femoral neck, total hip, total hip T-score, lumbar spine and the lumbar spine T-score, whereas FSH and estradiol correlated with the lumbar spine T-score ( p < 0.05). Conclusions During the 24 months of follow-up, treatment with anastrozole decreased the serum levels of estradiol and LH. Furthermore, we found notable increases of serum levels of FSH, DHEAS and testosterone in the first 12 months of treatment, stabilizing thereafter. Additionally, we were able to correlate hormone levels with markers of bone turnover and BMD for the first time in this regard. [ABSTRACT FROM AUTHOR]

Objectives The use of aromatase inhibitors for the adjuvant treatment of breast cancer may affect the quality of life of patients, as well as adherence to treatment. Methods Here we report the 2-year results of the 180 patients in the COMPAS study. This is the first randomized, controlled study reporting on menopausal symptoms under endocrine treatment with aromatase inhibitors in breast cancer patients, based on the Menopause Rating Scale. We analyzed the prevalence of menopausal symptoms as well as their associations with patient adherence. Results Baseline characteristics showed no significant differences among the control and the intervention groups. The majority of women experienced the symptoms at various severities. Overall, we found an increase in the prevalence of hot flushes, sleep disorders, bladder problems, dryness of the vagina as well as of joint and muscular discomfort between the 12- and 24-month visits. In compliant patients, all symptoms except for vaginal dryness improved between the 12- and 24-month visits while, in non-compliant women, hot flushes, irritability, dryness of the vagina as well as joint and muscular discomfort deteriorated. When comparing compliant and non-compliant patients, we found a significant difference only for anxiety ( p = 0.028) in the 12-month analysis, as well as a large but non-significant difference for heart discomfort ( p = 0.089) in the 24-month visit. Conclusions Our results indicate that the majority of women treated with aromatase inhibitors are experiencing menopausal symptoms at various severities. We showed that the mean symptom values in compliant patients improve with longer therapy duration. Furthermore, anxiety correlates with better compliance, while heart discomfort may lead to therapy discontinuation. [ABSTRACT FROM AUTHOR]

Aim To systematically review randomized, controlled clinical trials for managing osteoporosis, cancer treatment-induced bone loss, and bone metastases from breast cancer using zoledronic acid (ZOL). Methods A systematic review of published literature and meeting abstracts was conducted to examine the efficacy of ZOL dosing strategies in clinical trials of osteoporosis, adjuvant therapy for breast cancer, and bone metastases from breast cancer. Bone resorption rates, tumor burden, skeletal health goals, and clinical data were considered when assessing ZOL in each setting. Results Dosing schedules vary between approved indications for osteoporosis and bone metastases and the investigational use in women receiving endocrine therapy for BC, taking into consideration the different levels of bone loss and tumor burden in each setting. Gradual bone loss in healthy postmenopausal women with osteopenia or osteoporosis can be prevented or treated with the approved biennial or annual ZOL (5 mg), respectively. Rapid bone loss in patients receiving adjuvant chemotherapy and/or endocrine therapy for early-stage BC and low tumor burden is managed in the clinical setting with ZOL 4 mg every 6 months. In patients with bone metastases, very high tumor burden, high bone resorption levels, and decreases in bone integrity are managed by the approved ZOL schedule (4 mg every 3--4 weeks) to prevent skeleton-related events. Conclusions Dosing schedules are based on clinical evidence and vary depending on goals of therapy, rate of bone loss, and tumor burden. ZOL 5 mg every 12 months and every 24 months are approved for osteoporosis and osteopenia, respectively, whereas ZOL 4 mg every 6 months has been used during adjuvant endocrine therapy and ZOL 4 mg every 3--4 weeks is approved for managing bone metastases. [ABSTRACT FROM AUTHOR]

Objective A major impediment in osteoporosis care is poor therapeutic adherence. Real-life surveys show that adherence and persistence with oral bisphosphonates decrease to 30--60%% within 1 year. The aim of this study was to analyze the adherence and persistence with raloxifene in patients visiting our outpatient clinic. Material and methods A total of 342 patients were evaluated from the conventional osteoporosis practice receiving treatment with raloxifene. Patient self-reporting was combined with the medication possession ratio (MPR) assessed via prescription refill counts. In addition, persistence and other self-reported and patient file-based data were assessed. Results The final analysis comprised 300 patients with a mean age of 66.3 years (standard deviation ±± 7.2 years). At 6 months 84%%, at 12 months 81%%, at 24 months 78%% and at 36 months 77%% of patients were persistent with therapy according to patients' self-reports. If MPR and self-reported data were combined, 56%%, 48%% and 35%% of patients remained on therapy at 12, 24 and 36 months, respectively. The mean duration of therapy was 19 months with a mean MPR of 52.8%%. Finally, 31.7%% of all patients were classified as adherent. Significant correlation to adherence was found for tolerability and motivational factors. Conclusion This study revealed that approximately half of the patients treated with raloxifene in regular clinical practice stay on therapy for the first 2 years. Furthermore, the patients do not adhere sufficiently to the recommended dosage, and reduced clinical efficacy in clinical practice is presumable. The reasons for non-adherence comprise tolerability and motivational factors but further investigation is needed. [ABSTRACT FROM AUTHOR]