Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus
Palabras clave
Abstracto
Descripción
In the first part of the study, 150 consecutive patients with a diagnosis of SLE were included in the study. All patients fulfilled the American College of Rheumatology (ACR) revised criteria for the classification of SLE and provided written informed consent. Data collected at the time of study inclusion were age, disease duration, race, menstrual status, age at menopause, periods of amenorrhea, family history of osteoporosis, ultraviolet (UV) light intolerance, sunshine avoidance, use of sunscreens in the previous year, calculated mean daily dietary calcium intake in the last 3 months, history of (non)vertebral fractures after the age of 25 years, comorbidity, alcohol and tobacco intake, and exercise status.Body weight, height, and body mass index (BMI) were assessed. Disease activity was scored using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 54. Accumulated organ damage was assessed with the SLICC/ ACR damage index (DI) 55. A modified DI score was derived as the DI score excluding osteoporotic fractures as a damage item.BMD measurements of the hip (total hip and femoral neck) and the lumbar spine (L1-4; anteroposterior view) as well as lateral radiographs of the thoracic and lumbar spine (T5-L4)were performed. The prevalence of low BMD and vertebral fractures will be assessed.
In the second part of the study, 40 female SLE patients with steroid induced osteopenia will be enrolled in a 12-month, randomized, parallel-group, controlled study. Patients will receive either oral Ibandronate 150 mg once monthly plus daily alfacalcidol (0.001 mg) or placebo ibandronate once monthly plus daily alfacalcidol(0.001mg).In addition, the intake of dietary calcium will estimate by a questionnaire on the screening visit. All patients will receive a daily calcium supplement(500 mg).
Primary outcome is the improvement of bone mineral density measured by DEXA.
Secondary outcome includes:
1. Evaluation of the changes in bone mineralization and architecture measured by Xtreme CT.
2. Evaluation of the changes in perfusion and marrow edema using MRI.
3. Anti-proliferative and anti-inflammatory action of alfacalcidol using serum level of interleukin-6 (IL-6), transforming growth factor-beta-1, angiotensin-II, as well as urinary levels of TGF and monocyte chemoattractant protein-1 (MCP-1).
fechas
| Verificado por última vez: | 01/31/2012 |
| Primero enviado: | 04/24/2008 |
| Inscripción estimada enviada: | 04/27/2008 |
| Publicado por primera vez: | 04/28/2008 |
| Última actualización enviada: | 02/09/2012 |
| Última actualización publicada: | 02/12/2012 |
| Fecha de inicio real del estudio: | 03/31/2007 |
| Fecha estimada de finalización primaria: | 04/30/2009 |
| Fecha estimada de finalización del estudio: | 04/30/2009 |
Condición o enfermedad
Intervención / tratamiento
Drug: Ibandronate+alfacalcidol+calcium
Drug: placebo ibandronate+alfacalcidol+calcium
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: Ibandronate+alfacalcidol+calcium Bonviva | |
| Active Comparator: Placebo ibandronate+alfacalcidol+calcium |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | Female |
| Acepta voluntarios saludables | si |
| Criterios | Part I Inclusion Criteria: - Fulfilled the ACR revised criteria for the classification of SLE - Provided written informed consent for their participation Part II Inclusion Criteria: - Have low BMD (T socre < -1 S.D. at the lumbar spine (L1-L4) or total hip) induced by the long-term administration of high-dose corticosteroids. - Had been receiving chronic uninterrupted corticosteroid therapy for at least 1 year or had received a corticosteroid dose of at least 5 mg/day. Exclusion Criteria: - Hypocalcaemia, hypercalcaemia, Hypercalciuria, a creatinine clearance of less than 30 ml per minute. - A history of nephrolithiasis during the previous five years. - A history of recent major gastrointestinal (GI) tract disease (e.g. oesophagitis). - Had or presence of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism in the year before the study began. - Had experienced any previous adverse reaction to bisphosphonate therapy (alendronate, fosamax, ibandronate). - With uncontrolled active or recurrent peptic ulcer disease. - Receiving therapy (within the last 6 months) known to affect bone metabolism, including:hormone-replacement agents, calcitonin, active vitamin D3 analogues, thiazide diuretics,treatment with bisphosphonates,fluoride treatment within the last 12 mons or for a total duration of 2 years; contraindications to calcium or vitamin D therapy. - Pregnant or breastfeeding. |
Salir
Medidas de resultado primarias
1. The primary outcome of Part I study is to investigate the prevalence of low BMD and vertebral fractures. Primary outcome of part II study is the improvement of bone mineral density measured by DEXA. [baseline and month 12]
Medidas de resultado secundarias
1. Evaluation of the changes in bone mineralization and architecture measured by Xtreme CT. [baseline, month 6 and month 12]
2. Evaluation of the changes in perfusion and marrow edema using MRI. [baseline, month 6, month 12]
