Efecto protector de los análogos de la GnRH sobre la capacidad reproductiva de las mujeres en edad fértil con neoplasia o enfermedad autoinmunitaria tratadas con fármacos citotóxicos. Resultado final de un ensayo clínico fase II / Protective effect of GnRH analogues on the reproductive capacity of women with neoplasia or autoimmune disease who require chemotherapy. Final results of a phase ii clinical trial

Fundamento y objetivo: Para evitar el efecto tóxico quimioterápico se ha propuesto la utilización de análogos agonistas de la GnRH (aGnRH) para inhibir la depleción de folículos ováricos. Existen controversias sobre su eficacia, por lo que se ha realizado un ensayo clínico para valorar el efecto protector de los análogos de la GnRH en mujeres afectadas de cáncer y enfermedades autoinmunitarias tratadas con fármacos citotóxicos. Pacientes y métodos: Ensayo clínico, de fase ii, unicéntrico y abierto. Durante el tratamiento quimioterápico se administraron 5 dosis de análogo antagonista de la GnRH en intervalos de 3 días y/o una dosis mensual de aGnRH. Se realizaron determinaciones hormonales previamente al inicio del tratamiento quimioterápico y al finalizar este. Resultados: La inclusión de las pacientes se concluyó precozmente al introducir como parámetro de evaluación de la reserva ovárica la determinación de hormona antimulleriana (HAM). De las 38 pacientes seguidas, 23 (60,5%, IC95% 43,4-76,0) presentaron valores de AMH por debajo de la normalidad tras la conclusión del tratamiento. Se realizó un análisis intermedio en el que se observó que el 86,6% (IC95% 71,9-95,6) de las pacientes recuperaban el ciclo menstrual, pero estas presentaban una reducción de los niveles de HAM. Conclusión: Aunque la mayoría de las pacientes presentaron recuperación de los ciclos menstruales, la reserva ovárica disminuyó en la mayoría de ellas, por lo que podemos concluir que la administración concomitante al tratamiento quimioterápico de análogos de la GnRH no preserva de la pérdida de la población folicular ovárica (AU)

Background and objective: In order to avoid the toxic effect of chemotherapy, it has been proposed to use GnRH agonist analogues (GnRHa) to inhibit the depletion of ovarian follicles. Nevertheless, there is controversy about its effectiveness. This clinical trial has been conducted with the aim to assess the protective effect of GnRH analogues on the reproductive capacity of women with malignancies or autoimmune diseases, which require chemotherapy. Patients and methods: Open phase ii single-center clinical trial. During chemotherapy, a total of 5 doses of GnRH antagonist analogue at a dose interval of 3 days and/or a monthly dose of GnRHa were administered. Hormonal determinations prior to the start of the CT treatment were conducted during treatment and at the end of it. Results: The inclusion of patients was prematurely concluded when incorporating the determination of anti-Müllerian hormone (AMH) as a parameter for assessing the ovarian reserve. Out of 38 patients, 23 (60.5%, 95%CI 43.4-76.0) had AMH values below normal following completion of treatment. An intermediate analysis was carried out observing that while most patients were recovering the menstrual cycle (86.6% 95%CI 71.9-95.6), they had reduced levels of AMH. Conclusion: Although most patients recovered their menstrual cycles, the ovarian reserve, assessed by the concentration of AMH, decreased in many patients. Therefore, we can conclude that the concomitant treatment of chemotherapy and GnRH analogues does not preserve the loss of follicular ovarian reserve (AU)

[Protective effect of GnRH analogues on the reproductive capacity of women with neoplasia or autoimmune disease who require chemotherapy. Final results of a phase ii clinical trial]. / Efecto protector de los análogos de la GnRH sobre la capacidad reproductiva de las mujeres en edad fértil con neoplasia o enfermedad autoinmunitaria tratadas con fármacos citotóxicos. Resultado final de un ensayo clínico fase II.

BACKGROUND AND OBJECTIVE: In order to avoid the toxic effect of chemotherapy, it has been proposed to use GnRH agonist analogues (GnRHa) to inhibit the depletion of ovarian follicles. Nevertheless, there is controversy about its effectiveness. This clinical trial has been conducted with the aim to assess the protective effect of GnRH analogues on the reproductive capacity of women with malignancies or autoimmune diseases, which require chemotherapy. PATIENTS AND METHODS: Open phase ii single-center clinical trial. During chemotherapy, a total of 5 doses of GnRH antagonist analogue at a dose interval of 3 days and/or a monthly dose of GnRHa were administered. Hormonal determinations prior to the start of the CT treatment were conducted during treatment and at the end of it. RESULTS: The inclusion of patients was prematurely concluded when incorporating the determination of anti-Müllerian hormone (AMH) as a parameter for assessing the ovarian reserve. Out of 38 patients, 23 (60.5%, 95%CI 43.4-76.0) had AMH values below normal following completion of treatment. An intermediate analysis was carried out observing that while most patients were recovering the menstrual cycle (86.6% 95%CI 71.9-95.6), they had reduced levels of AMH. CONCLUSION: Although most patients recovered their menstrual cycles, the ovarian reserve, assessed by the concentration of AMH, decreased in many patients. Therefore, we can conclude that the concomitant treatment of chemotherapy and GnRH analogues does not preserve the loss of follicular ovarian reserve.

Utilidad de la herramienta FRAX en el tratamiento de la osteoporosis en población femenina española / Usefulness of FRAX tool for the management of osteoporosis in the Spanish female population

Fundamento y objetivo: Las fracturas osteoporóticas conllevan un importante consumo de recursos sanitarios. La densitometría ósea ha sido básica en el manejo de la osteoporosis, pero en la predicción del riesgo absoluto de fractura también son importantes otros factores de riesgo. La Organización Mundial de la Salud (OMS) publicó la herramienta FRAX y la National Osteoporosis Guideline Group (NOGG), más recientemente, los umbrales coste-efectivos para solicitar densitometría. Nuestro objetivo es conocer la capacidad predictiva para detectar osteoporosis del FRAX en nuestra población y conocer cómo se modificarían las derivaciones para densitometría aplicando las guías NOGG. Sujetos y método: Estudio de validación diagnóstica en 1.650 mujeres entre 50 y 90 años, sin tratamiento antirresortivo previo de la cohorte FRIDEX. Se realizó densitometría y cuestionario de factores de riesgo. Se compararon los resultados pre y posdensitometría. Se analizó la curva ROC y el área bajo la curva de FRAX predensitometría para predecir osteoporosis. Se calculó el riesgo FRAX predensitometría aplicando umbrales NOGG para determinar a quién debería habérsele realizado densitometría.Resultados: El área bajo la curva para validez diagnóstica de osteoporosis densitométrica de FRAX predensitometría fue 81,2% para fractura principal y 83,1% para fractura de cadera. Aplicando umbrales NOGG a FRAX predensitometría, se derivarían a densitometría el 25,2% de las realizadas. Si añadimos el 24,2% con fractura previa, llegarían al 49,4% de los casos analizados.Conclusión: FRAX es útil para predecir la presencia de osteoporosis. La utilización de los umbrales de las guías NOGG a la herramienta FRAX reduciría al 50% el número de densitometrías realizadas en nuestra práctica clínica actual (AU)

Background and objective: Osteoporotic fractures involve a significant consumption of health resources. Bone densitometry has been essential in the management of osteoporosis. However, for fracture absolute risk prediction, other important clinical risk factors are also important. WHO published a risk estimation tool (FRAX), and the National Osteoporosis Guideline Group (NOGG) reported thresholds for densitometry assessment based on cost-effectivity criteria. Our goal is to determine the diagnostic predictive validity of FRAX in our population, and to assess how its use (according to NOGG guidelines) would modify the current number of referrals to DXA scan in our health system. Subjects and methods:Diagnostic validation study in a consecutive sample of 1,650 women, 50 to 90 years old, under no treatment with anti-resortives, from the FRIDEX cohort. DXA and a questionnaire regarding risk factors were performed. ROC curve and area under the curve (AUC) were used to assess FRAX's diagnostic validity for femoral neck osteoporosis (FNOP). Risk of fracture was calculated using FRAX pre and postDXA, and women were classified according to their risk, following NOGG recommendations.Results: FRAX's ROC AUC for FNOP was 0.812 for major fracture and 0.832 for hip fracture. Using FRAX according to NOGG would result in performing only 25.2% of the current tests. If we added previous fracture antecedent to the algorithm, 49.4% of the tests performed would be advised.Conclusions: The use of NOGG thresholds applied to FRAX would reduce about 50% the current number of referrals to DXA scan in our population. FRAX has a good diagnostic validity for FNOP (AU)

[Usefulness of FRAX tool for the management of osteoporosis in the Spanish female population]. / Utilidad de la herramienta FRAX en el tratamiento de la osteoporosis en población femenina española.

BACKGROUND AND OBJECTIVE: Osteoporotic fractures involve a significant consumption of health resources. Bone densitometry has been essential in the management of osteoporosis. However, for fracture absolute risk prediction, other important clinical risk factors are also important. WHO published a risk estimation tool (FRAX), and the National Osteoporosis Guideline Group (NOGG) reported thresholds for densitometry assessment based on cost-effectivity criteria. Our goal is to determine the diagnostic predictive validity of FRAX in our population, and to assess how its use (according to NOGG guidelines) would modify the current number of referrals to DXA scan in our health system. SUBJECTS AND METHODS: Diagnostic validation study in a consecutive sample of 1,650 women, 50 to 90 years old, under no treatment with anti-resortives, from the FRIDEX cohort. DXA and a questionnaire regarding risk factors were performed. ROC curve and area under the curve (AUC) were used to assess FRAX's diagnostic validity for femoral neck osteoporosis (FNOP). Risk of fracture was calculated using FRAX pre and postDXA, and women were classified according to their risk, following NOGG recommendations. RESULTS: FRAX's ROC AUC for FNOP was 0.812 for major fracture and 0.832 for hip fracture. Using FRAX according to NOGG would result in performing only 25.2% of the current tests. If we added previous fracture antecedent to the algorithm, 49.4% of the tests performed would be advised. CONCLUSIONS: The use of NOGG thresholds applied to FRAX would reduce about 50% the current number of referrals to DXA scan in our population. FRAX has a good diagnostic validity for FNOP.