E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Preventing loss of bone density in patients with spinal cord injury of traumatic etiology complete during the first year of evolution of the lesion. |
Prevención de la pérdida de la densidad de la masa ósea en pacientes con lesión de la médula espinal completa de etiología traumática durante el primer año de evolución de la lesión. |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of osteoporosis in the first year of spinal cord injury of traumatic etiology |
Prevención de la osteoporosis durante el primer año de la lesión de la médula espinal de etiología traumática |
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E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10041543 |
E.1.2 | Term | Spinal cord and nerve root disorders |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Knowing the effectiveness in preventing bone loss in the population studied, treatment with calcifediol (to maintain serum 25 (OH) vitamin D ≥ 30 ng / ml) plus calcium-rich diet (1200 mg / day) and alendronatato, with respect to treatment with calcifediol (to maintain serum 25 (OH) vitamin D ≥ 30 ng / ml) plus calcium-rich diet (1200 mg / day). We understand effectiveness of bone mass difference between the two groups, measured by DEXA in the lower limbs ("total body legs") of 4% or higher for the group receiving alendronate. |
Conocer la eficacia para prevenir la pérdida de masa ósea, en la población estudiada, del tratamiento con calcifediol (para mantener niveles séricos de 25(OH)vitamina D ≥ 30 ng/ml), más dieta enriquecida en calcio (1200 mg/día) y alendronatato, con respecto al tratamiento con calcifediol (para mantener niveles séricos de 25(OH)vitamina D ≥ 30 ng/ml), más dieta enriquecida en calcio (1200 mg/día). Entendemos por eficacia una diferencia de masa ósea entre los dos grupos, medida por DEXA en miembros inferiores (“total body legs”) de un 4% o mayor, a favor del grupo que recibe alendronato. |
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E.2.2 | Secondary objectives of the trial |
To determine the safety of treatment (incidence of moderate to severe hypercalcemia, incidence of moderate-severe hypercalciuria, hyperphosphatemia incidence of moderate to severe incidence of calcium urolithiasis, ectopic calcification incidence). Find a pattern of action in preventing bone loss in the study population. Describe the evolution of bone turnover markers (β-CTX, bone alkaline phosphatase, osteocalcin and intact P1NP) in serum in the two treatment groups |
Determinar la seguridad del tratamiento (incidencia de hipercalcemia moderada-grave, incidencia de hipercalciuria moderada-grave, incidencia de hiperfosfatemia moderada-grave, incidencia de litiasis urinaria cálcica, incidencia de calcificaciones ectópicas). Encontrar una pauta de actuación para prevenir la pérdida de masa ósea en la población de estudio. Describir la evolución de los marcadores de remodelado óseo (β-CTX, fosfatasa alcalina ósea, osteocalcina intacta y P1NP) en suero en los dos grupos de tratamiento. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with spinal cord injury (SCI) of traumatic etiology of 8 or fewer weeks of evolution, men and women between 18 and 50 years of age, motor complete injuries, ie ASIA A and B grade, level of spinal injury cord, from C4 to L1. |
Pacientes con lesión de la medula espinal (LME) de etiología traumática de 8 o menos semanas de evolución; hombres y mujeres entre 18 y 50 años de edad; lesiones completas motoras, es decir grado ASIA A y B; nivel de lesión de la médula espinal: desde C4 a L1. |
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E.4 | Principal exclusion criteria |
Hypercalcemia (corrected Ca ≥ 12 mg / dl and / or Ca ion ≥ 5.54 mg / dl) prior to the LME menopause, previous treatment with bisphosphonates, patients who are pregnant or nursing, chronic renal insufficiency (CrCl <60 ml / min ), primary hyperparathyroidism, hyperthyroidism longstanding untreated, kidney stones and / or urological surgery, treatment with lithium, thiazides, esophagitis, carcinoma of the esophagus. Other risk factors for fracture: Type 1 diabetes, rheumatoid arthritis, chronic treatment with corticosteroids, osteogenesis imperfecta, malabsorption, chronic malnutrition and chronic liver disease. Unable to maintain sitting position for at least half an hour. Failure to obtain informed consent. |
Hipercalcemia (Ca corregido ≥ 12 mg/dl y/o Ca iónico ≥ 5.54 mg/dl); menopausia previa a la LME; tratamiento previo con bifosfonatos; pacientes embarazadas ó en periodo de lactancia; insuficiencia renal crónica (ClCr <60 ml/min); hiperparatiroidismo primario; hipertiroidismo de larga evolución no tratado; litiasis renal y/o urológica; tratamiento con litio, tiazidas; esofagitis; carcinoma de esófago;. Otros factores de riesgo de fractura: DM tipo 1, artritis reumatoide, tratamiento crónico con corticoides, osteogénesis imperfecta, malabsorción, malnutrición crónica y hepatopatía crónica. Imposibilidad para mantener la sedestación durante al menos media hora. Imposibilidad de obtener el consentimiento informado. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference between groups in the percentage reduction in bone mineral density with respect to the time of injury, after 12 months of treatment. The bone density was measured by densitometry of dual-energy radiograph absorptiometry (DEXA) in anterior lumbar spine, both hips and full body, team Hologic Explorer / W' |
Diferencia entre los grupos en el porcentaje de reducción de densidad mineral ósea con respecto al momento de la lesión, al cabo de 12 meses de tratamiento. La densidad de masa ósea se medirá por densitometría ósea de Rx de doble energía (DEXA) en columna lumbar anterior, ambas caderas y cuerpo completo, en equipo Hologic Explorer / W’’. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The year of treatment with alendronate |
Al año de tratamiento con alendronato |
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E.5.2 | Secondary end point(s) |
In blood, total calcium, albumin-corrected calcium, ionized calcium, phosphorus, magnesium, total alkaline phosphatase, 25OH vitamin D, 1.25 (OH) 2 vitamin D, PTH, β-CTX, bone alkaline phosphatase, osteocalcin and P1NP intact . In 24-hour urine calcium, phosphorus, magnesium and creatinine clearance. In isolated voiding urine: calcium / creatinine ratio. |
En sangre: calcio total, calcio corregido con albúmina, calcio iónico, fósforo, magnesio, fosfatasa alcalina total, 25OH vitamina D, 1,25 (OH)2 vitamina D, PTH, β-CTX, fosfatasa alcalina ósea, osteocalcina intacta y P1NP. En orina de 24 horas: calcio, fósforo, magnesio y aclaramiento de creatinina. En orina de micción aislada: cociente calcio/creatinina. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Once a month |
Una vez al mes |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
grupo sin tratamiento |
untreated group |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |