Menopause and hormone replacement therapy: the 2017 Recommendations of the Italian Menopause Society.
Gambacciani Marco,Biglia Nicoletta,Cagnacci Angelo,Caruso Salvatore,Cicinelli Ettore,DE Leo Vincenzo,DI Carlo Costantino,Farris Manuela,Gambera Alessandro,Guaschino Secondo,Lanzone Antonio,Paoletti Anna M,Russo Novella,Vicariotto Franco,Villa Paola,Volpe Annibale,
Minerva ginecologica
Over the last decade, the risk benefits ratio of hormone replacement therapy (HRT) has been reevaluated mainly in tens of cardiovascular risk. Present Consensus Statement is largely inspired by the Global Consensus on Menopausal Hormone Therapy in 2013 and 2016 by leading global menopause societies (The American Society for Reproductive Medicine, The Asia Pacific Menopause Federation, The Endocrine Society, The European Menopause and Andropause Society, The International Menopause Society, The International Osteoporosis Foundation and The North American Menopause Society). The aim of these recommendations is to provide a simple and updated reference on postmenopausal HRT. The term HRT typically includes estrogen replacement therapy (ERT) and estrogen-progestogen therapy (EPT). EPT can be sequential, when progestogen is added to ERT for 10-14 days a month, or continuous combined when progestogen is administered continuously every day along with a fixed amount of estrogen, In the everyday language, HRT includes also tibolone and the tissue-selective estrogen complex.
10.23736/S0026-4784.17.04151-X
Persistence, adherence, and medication-taking behavior in women with postmenopausal osteoporosis receiving denosumab in routine practice in Germany, Austria, Greece, and Belgium: 12-month results from a European non-interventional study.
Hadji P,Papaioannou N,Gielen E,Feudjo Tepie M,Zhang E,Frieling I,Geusens P,Makras P,Resch H,Möller G,Kalouche-Khalil L,Fahrleitner-Pammer A
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA
UNLABELLED:Persistence with and adherence to osteoporosis therapy are critical for fracture reduction. This non-interventional study is evaluating medication-taking behavior of women with postmenopausal osteoporosis (PMO) receiving denosumab in Germany, Austria, Greece, and Belgium. Patients were representative of the PMO population and highly persistent with and adherent to denosumab at 12 months. INTRODUCTION:Persistence with and adherence to osteoporosis therapy are important for optimal treatment efficacy, namely fracture reduction. This ongoing, non-interventional study will evaluate medication-taking behavior of women with postmenopausal osteoporosis (PMO) receiving denosumab in routine practice in four European countries. METHODS:The study enrolled women who had been prescribed subcutaneous denosumab (60 mg every 6 months) in accordance with prescribing information and local guidelines. Persistence was defined as receiving the subsequent injection within 6 months + 8 weeks of the previous injection. Adherence was defined as receiving two consecutive injections within 6 months ± 4 weeks of each other. Medication coverage ratio (MCR) was calculated using the time a patient was covered with denosumab, as assessed from prescription records. Treatment was assigned prior to and independently of enrollment; outcomes are recorded during routine practice. RESULTS:These planned 12-month interim analyses included data from 1500 patients from 141 sites. Mean age was 66.4-72.4 years, mean baseline total hip T-scores ranged from -2.0 to -2.1 and femoral neck T-scores from -2.2 to -2.6, and 30.7-62.1% of patients had prior osteoporotic fracture. Persistence was 87.0-95.3%, adherence 82.7-89.3%, and MCR 91.3-95.4%. In a univariate analysis, increased age, decreased mobility, and increased distance to the clinic were associated with significantly decreased persistence; parental history of hip fracture was associated with significantly increased persistence. CONCLUSIONS:These data extend the real-world evidence regarding persistence with and adherence to denosumab, both of which are critical for favorable clinical outcomes, including fracture risk reduction.
10.1007/s00198-015-3164-4
The Belgian Bone Club 2020 guidelines for the management of osteoporosis in postmenopausal women.
Sanchez-Rodriguez D,Bergmann P,Body J J,Cavalier E,Gielen E,Goemaere S,Lapauw B,Laurent M R,Rozenberg S,Honvo G,Beaudart C,Bruyère O
Maturitas
PURPOSE:To provide updated evidence-based guidelines for the management of osteoporosis in postmenopausal women in Belgium. METHODS:The Belgian Bone Club (BBC) gathered a guideline developer group. Nine "Population, Intervention, Comparator, Outcome" (PICO) questions covering screening, diagnosis, non-pharmacological and pharmacological treatments, and monitoring were formulated. A systematic search of MEDLINE, the Cochrane Database of Systematic Reviews, and Scopus was performed to find network meta-analyses, meta-analyses, systematic reviews, guidelines, and recommendations from scientific societies published in the last 10 years. Manual searches were also performed. Summaries of evidence were provided, and recommendations were further validated by the BBC board members and other national scientific societies' experts. RESULTS:Of the 3840 references in the search, 333 full texts were assessed for eligibility, and 129 met the inclusion criteria. Osteoporosis screening using clinical risk factors should be considered. Patients with a recent (<2 years) major osteoporotic fracture were considered at very high and imminent risk of future fracture. The combination of bone mineral density measured by dual-energy X-ray absorptiometry and 10-year fracture risk was used to categorize patients as low or high risk. Patient education, the combination of weight-bearing and resistance training, and optimal calcium intake and vitamin D status were recommended. Antiresorptive and anabolic osteoporosis treatment should be considered for patients at high and very high fracture risk, respectively. Follow-up should focus on compliance, and patient-tailored monitoring should be considered. CONCLUSION:BBC guidelines and 25 guideline recommendations bridge the gap between research and clinical practice for the screening, diagnosis, and management of osteoporosis.
10.1016/j.maturitas.2020.05.006
Calcium in the prevention of postmenopausal osteoporosis: EMAS clinical guide.
Cano Antonio,Chedraui Peter,Goulis Dimitrios G,Lopes Patrice,Mishra Gita,Mueck Alfred,Senturk Levent M,Simoncini Tommaso,Stevenson John C,Stute Petra,Tuomikoski Pauliina,Rees Margaret,Lambrinoudaki Irene
Maturitas
INTRODUCTION:Postmenopausal osteoporosis is a highly prevalent disease. Prevention through lifestyle measures includes an adequate calcium intake. Despite the guidance provided by scientific societies and governmental bodies worldwide, many issues remain unresolved. AIMS:To provide evidence regarding the impact of calcium intake on the prevention of postmenopausal osteoporosis and critically appraise current guidelines. MATERIALS AND METHODS:Literature review and consensus of expert opinion. RESULTS AND CONCLUSION:The recommended daily intake of calcium varies between 700 and 1200mg of elemental calcium, depending on the endorsing source. Although calcium can be derived either from the diet or supplements, the former source is preferred. Intake below the recommended amount may increase fragility fracture risk; however, there is no consistent evidence that calcium supplementation at, or above, recommended levels reduces risk. The addition of vitamin D may minimally reduce fractures, mainly among institutionalised people. Excessive intake of calcium, defined as higher than 2000mg/day, can be potentially harmful. Some studies demonstrated harm even at lower dosages. An increased risk for cardiovascular events, urolithiasis and even fractures has been found in association with excessive calcium intake, but this issue remains unresolved. In conclusion, an adequate intake of calcium is recommended for general bone health. Excessive calcium intake seems of no benefit, and could possibly be harmful.
10.1016/j.maturitas.2017.10.004
AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS/AMERICAN COLLEGE OF ENDOCRINOLOGY CLINICAL PRACTICE GUIDELINES FOR THE DIAGNOSIS AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS- 2020 UPDATE .
Camacho Pauline M,Petak Steven M,Binkley Neil,Diab Dima L,Eldeiry Leslie S,Farooki Azeez,Harris Steven T,Hurley Daniel L,Kelly Jennifer,Lewiecki E Michael,Pessah-Pollack Rachel,McClung Michael,Wimalawansa Sunil J,Watts Nelson B
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
The development of these guidelines is sponsored by the American Association of Clinical Endocrinologists (AACE) Board of Directors and American College of Endocrinology (ACE) Board of Trustees and adheres with published AACE protocols for the standardized production of clinical practice guidelines (CPGs). Recommendations are based on diligent reviews of the clinical evidence with transparent incorporation of subjective factors, according to established AACE/ACE guidelines for guidelines protocols. The Executive Summary of this 2020 updated guideline contains 52 recommendations: 21 Grade A (40%), 24 Grade B (46%), 7 Grade C (14%), and no Grade D (0%). These detailed, evidence-based recommendations allow for nuance-based clinical decision-making that addresses multiple aspects of real-world care of patients. The evidence base presented in the subsequent Appendix provides relevant supporting information for the Executive Summary recommendations. This update contains 368 citations: 123 (33.5%) evidence level (EL) 1 (highest), 132 (36%) EL 2 (intermediate), 20 (5.5%) EL 3 (weak), and 93 (25%) EL 4 (lowest). New or updated topics in this CPG include: clarification of the diagnosis of osteoporosis, stratification of the patient according to high-risk and very-high-risk features, a new dual-action therapy option, and transitions from therapeutic options. This guideline is a practical tool for endocrinologists, physicians in general, regulatory bodies, health-related organizations, and interested laypersons regarding the diagnosis, evaluation, and treatment of post-menopausal osteoporosis.
10.4158/GL-2020-0524
AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS/AMERICAN COLLEGE OF ENDOCRINOLOGY CLINICAL PRACTICE GUIDELINES FOR THE DIAGNOSIS AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS-2020 UPDATE.
Camacho Pauline M,Petak Steven M,Binkley Neil,Diab Dima L,Eldeiry Leslie S,Farooki Azeez,Harris Steven T,Hurley Daniel L,Kelly Jennifer,Lewiecki E Michael,Pessah-Pollack Rachel,McClung Michael,Wimalawansa Sunil J,Watts Nelson B
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
The development of these guidelines is sponsored by the American Association of Clinical Endocrinologists (AACE) Board of Directors and American College of Endocrinology (ACE) Board of Trustees and adheres with published AACE protocols for the standardized production of clinical practice guidelines (CPGs). Recommendations are based on diligent reviews of the clinical evidence with transparent incorporation of subjective factors, according to established AACE/ACE guidelines for guidelines protocols. The Executive Summary of this 2020 updated guideline contains 52 recommendations: 21 Grade A (40%), 24 Grade B (46%), 7 Grade C (14%), and no Grade D (0%). These detailed, evidence-based recommendations allow for nuance-based clinical decision-making that addresses multiple aspects of real-world care of patients. The evidence base presented in the subsequent Appendix provides relevant supporting information for the Executive Summary recommendations. This update contains 368 citations: 123 (33.5%) evidence level (EL) 1 (highest), 132 (36%) EL 2 (intermediate), 20 (5.5%) EL 3 (weak), and 93 (25%) EL 4 (lowest). New or updated topics in this CPG include: clarification of the diagnosis of osteoporosis, stratification of the patient according to high-risk and very-high-risk features, a new dual-action therapy option, and transitions from therapeutic options. This guideline is a practical tool for endocrinologists, physicians in general, regulatory bodies, health-related organizations, and interested laypersons regarding the diagnosis, evaluation, and treatment of post-menopausal osteoporosis. = 25-hydroxyvitamin D; = American Association of Clinical Endocrinologists; = American College of Endocrinology; = atypical femoral fracture; = American Society for Bone and Mineral Research; = best evidence level; = bone mineral density; = bone turnover marker; = confidence interval; = clinical practice guideline; = C-terminal telopeptide type-I collagen; = dual-energy X-ray absorptiometry; = evidence level; = U.S. Food and Drug Administration; = Fracture Risk Assessment Tool; = gastrointestinal; = Health Outcomes and Reduced Incidence with Zoledronic acid ONce yearly Pivotal Fracture Trial (zoledronic acid and zoledronate are equivalent terms); = International Society for Clinical Densitometry; = international units; = intravenous; = least significant change; = National Osteoporosis Foundation; = osteonecrosis of the jaw; = serum amino-terminal propeptide of type-I collagen; = parathyroid hormone; = recommendation; = region of interest; = relative risk; = standard deviation; = trabecular bone score; = vertebral fracture assessment; = World Health Organization.
10.4158/GL-2020-0524SUPPL
2018 update of French recommendations on the management of postmenopausal osteoporosis.
Briot Karine,Roux Christian,Thomas Thierry,Blain Hubert,Buchon Daniel,Chapurlat Roland,Debiais Françoise,Feron Jean Marc,Gauvain Jean Bernard,Guggenbuhl Pascal,Legrand Eric,Lehr-Drylewicz Anne Marie,Lespessailles Eric,Tremollieres Florence,Weryha Georges,Cortet Bernard
Joint bone spine
OBJECTIVES:To update the 2012 recommendations on pharmacotherapy for postmenopausal osteoporosis, under the aegis of the Bone Task Force of the French Society for Rheumatology (SFR) and of the Osteoporosis Research and Information Group (GRIO), in collaboration with scientific societies (Collège national des généralistes enseignants, Collège national des gynécologues et obstétriciens français, Fédération nationale des collèges de gynécologie médicale, Groupe d'étude de la ménopause et du vieillissement hormonal, Société française de chirurgie orthopédique, Société française d'endocrinologie, and Société française de gériatrie et de gérontologie). METHODS:Updated recommendations were developed by a task force whose members represented the medical specialties involved in the management of postmenopausal osteoporosis. The update was based on a literature review and developed using the method advocated by the French National Authority for Health (HAS). DISCUSSION AND CONCLUSION:The updated recommendations place strong emphasis on the treatment of women with severe fractures, in whom the use of osteoporosis medications is recommended. All the available osteoporosis medications are suitable in patients with severe fractures; zoledronic acid deserves preference as the fist-line drug after a hip fracture. In patients with or without non-severe fractures, the decision to use osteoporosis medications is based on bone mineral density values and in challenging cases, on probabilities supplied by prediction tools such as FRAX. All osteoporosis medications are suitable; raloxifene should be reserved for patients at low risk for peripheral fractures. The fracture risk should be reevaluated every 2 to 3 years to decide on the best follow-up treatment. These updated recommendations discuss the selection of first-line osteoporosis medications and treatment sequences.
10.1016/j.jbspin.2018.02.009