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Sponsored by: |
Chinese University of Hong Kong |
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Information provided by: | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00668330 |
The primary aim of the present study was to investigate the prevalence of low BMD and vertebral fractures, as determined by a standardized assessment, and to elucidate the role of bone qualities, including micro-architecture, bone remodeling, bone turnover, mineralization and inflammation on bone density and prevalent vertebral fractures in a large population of SLE patients.
The secondary aim of the study is to evaluate the following parameters in women with steroid induced OP (SIOP) before and after 1 year of treatment using:
Condition | Intervention | Phase |
---|---|---|
Systemic Lupus Erythematosus |
Drug: Ibandronate + daily alfacalcidol + calcium Drug: placebo ibandronate + alfacalcidol and calcium |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus-Prevalence,Risk Factors and Treatment |
Estimated Enrollment: | 40 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Ibandronate + daily alfacalcidol + calcium
Ibandronate 150 mg monthly plus daily alfacalcidol (1ug)500mg calcium
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2: Experimental |
Drug: placebo ibandronate + alfacalcidol and calcium
placebo ibandronate monthly plus daily alfacalcidol(1ug)500mg calcium
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In the first part of the study, 150 consecutive patients with a diagnosis of SLE were included in the study. All patients fulfilled the 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:
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Part I
Inclusion Criteria:
Part II
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | The Chinese University of Hong Kong ( Lai-Shan Tam ) |
Study ID Numbers: | SLE-2007-007 |
Study First Received: | April 25, 2008 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00668330 |
Health Authority: | Hong Kong: Department of Health |
Bone mineral density ibandronate alfacalcidol |
Calcium, Dietary Autoimmune Diseases Ibandronic acid Musculoskeletal Diseases Lupus Erythematosus, Systemic 1-hydroxycholecalciferol |
Connective Tissue Diseases Osteoporosis Bone Diseases, Metabolic Bone Diseases Hydroxycholecalciferols |
Immune System Diseases Growth Substances Vitamins Physiological Effects of Drugs |
Bone Density Conservation Agents Micronutrients Pharmacologic Actions |