- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02972138
Vitamin D and Bisphosphonates in the Treatment of Sickle Cell Disease
Vitamin D Supplementation and Anti-resorptive Therapy (Bisphosphonates) Treatment of Young Adult Patients With Sickle Cell Disease
Study Overview
Status
Conditions
Detailed Description
This is a retrospective study aimed to evaluate sickle bone disease (SBD) in a population of young adult patients with sickle cell disease treated with vitamin D supplementation and anti-resorptive therapy (bisphosphonates). We plan to analyze data from 1 January 2010 to 31 December 2015.
In addition to the standard hematological analysis, the following parameters and radiologic exams will be evaluated:
- Serum levels of Ca2+, P, Vitamin D, parathormone , creatinine, blood urea nitrogen , Na, K, Cl
- Bone turnover markers: C-terminal telopeptide (CTX), N-terminal propeptide of type I procollagen (PINP)
- Bone densitometry (DXA) at lumbar spine and proximal femur
- Standard X-Ray at dorsal-lumbar spine in LL projection for morphometric analysis
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Genova, Italy, 16128
- Ospedali Galliera - S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro
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Genova, Italy, 16128
- Ospedali Galliera - S.S.D. Ortogeriatria per intensità di cure
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Verona, Italy, 37129
- Universita Degli Studi Di Verona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Young adult patients with sickle cell disease (older than 18 years of age) and younger than 50 years of age
Exclusion Criteria:
- Women with positive pregnant test, patients with history of heart, renal and liver failure, patients taking drugs influencing bone metabolisms within the two years before the beginning of the study (i.e.: glucocorticoids, hormonal replacement)
- Patients in meonopause, patients with traumatic vertebral fracture
- Patients with hypo/hyperthyroidism
- Patients with hyperparathyroidism
- Patients with osteomalacia, patients with history of Paget disease
- Patients with Cushing syndrome
- Patients with malabsorption diseases (i.e.: caeliac disease)
- Patients with history of cancer
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence of vertebral fracture
Time Frame: 5 years follow up
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5 years follow up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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severity of vertebral fracture
Time Frame: 5 years follow up
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5 years follow up
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Incidence of non-vertebral fracture
Time Frame: 5 years follow up
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5 years follow up
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Collaborators and Investigators
Investigators
- Principal Investigator: Luca G Dalle Carbonare, MD, Universita Degli Studi Di Verona
Publications and helpful links
General Publications
- Neves FS, Oliveira LS, Torres MG, Toralles MB, da Silva MC, Campos MI, Campos PS, Crusoe-Rebello I. Evaluation of panoramic radiomorphometric indices related to low bone density in sickle cell disease. Osteoporos Int. 2012 Jul;23(7):2037-42. doi: 10.1007/s00198-011-1810-z. Epub 2011 Oct 18.
- Modell B, Darlison M. Global epidemiology of haemoglobin disorders and derived service indicators. Bull World Health Organ. 2008 Jun;86(6):480-7. doi: 10.2471/blt.06.036673.
- Weatherall DJ, Clegg JB. Inherited haemoglobin disorders: an increasing global health problem. Bull World Health Organ. 2001;79(8):704-12. Epub 2001 Oct 24.
- De Franceschi L, Cappellini MD, Olivieri O. Thrombosis and sickle cell disease. Semin Thromb Hemost. 2011 Apr;37(3):226-36. doi: 10.1055/s-0031-1273087. Epub 2011 Mar 31.
- Eaton WA, Hofrichter J. Sickle cell hemoglobin polymerization. Adv Protein Chem. 1990;40:63-279. doi: 10.1016/s0065-3233(08)60287-9. No abstract available.
- De Franceschi L, Corrocher R. Established and experimental treatments for sickle cell disease. Haematologica. 2004 Mar;89(3):348-56.
- Ballas SK, Smith ED. Red blood cell changes during the evolution of the sickle cell painful crisis. Blood. 1992 Apr 15;79(8):2154-63.
- Vinchi F, De Franceschi L, Ghigo A, Townes T, Cimino J, Silengo L, Hirsch E, Altruda F, Tolosano E. Hemopexin therapy improves cardiovascular function by preventing heme-induced endothelial toxicity in mouse models of hemolytic diseases. Circulation. 2013 Mar 26;127(12):1317-29. doi: 10.1161/CIRCULATIONAHA.112.130179. Epub 2013 Feb 27.
- Hebbel RP, Vercellotti G, Nath KA. A systems biology consideration of the vasculopathy of sickle cell anemia: the need for multi-modality chemo-prophylaxsis. Cardiovasc Hematol Disord Drug Targets. 2009 Dec;9(4):271-92. doi: 10.2174/1871529x10909040271.
- Hebbel RP. Adhesion of sickle red cells to endothelium: myths and future directions. Transfus Clin Biol. 2008 Feb-Mar;15(1-2):14-8. doi: 10.1016/j.tracli.2008.03.011. Epub 2008 May 23.
- Platt OS. The acute chest syndrome of sickle cell disease. N Engl J Med. 2000 Jun 22;342(25):1904-7. doi: 10.1056/NEJM200006223422510. No abstract available. Erratum In: N Engl J Med 2000 Aug 24;343(8):591.
- Lal A, Fung EB, Pakbaz Z, Hackney-Stephens E, Vichinsky EP. Bone mineral density in children with sickle cell anemia. Pediatr Blood Cancer. 2006 Dec;47(7):901-6. doi: 10.1002/pbc.20681.
- Dalle Carbonare L, Innamorati G, Valenti MT. Transcription factor Runx2 and its application to bone tissue engineering. Stem Cell Rev Rep. 2012 Sep;8(3):891-7. doi: 10.1007/s12015-011-9337-4.
- Bruzzaniti A, Baron R. Molecular regulation of osteoclast activity. Rev Endocr Metab Disord. 2006 Jun;7(1-2):123-39. doi: 10.1007/s11154-006-9009-x.
- Dalle Carbonare L, Zanatta M, Gasparetto A, Valenti MT. Safety and tolerability of zoledronic acid and other bisphosphonates in osteoporosis management. Drug Healthc Patient Saf. 2010;2:121-37. doi: 10.2147/DHPS.S6285. Epub 2010 Aug 19.
- Dalle Carbonare L, Arlot ME, Chavassieux PM, Roux JP, Portero NR, Meunier PJ. Comparison of trabecular bone microarchitecture and remodeling in glucocorticoid-induced and postmenopausal osteoporosis. J Bone Miner Res. 2001 Jan;16(1):97-103. doi: 10.1359/jbmr.2001.16.1.97.
- Nouraie M, Cheng K, Niu X, Moore-King E, Fadojutimi-Akinsi MF, Minniti CP, Sable C, Rana S, Dham N, Campbell A, Ensing G, Kato GJ, Gladwin MT, Castro OL, Gordeuk VR. Predictors of osteoclast activity in patients with sickle cell disease. Haematologica. 2011 Aug;96(8):1092-8. doi: 10.3324/haematol.2011.042499. Epub 2011 May 5.
- Nur E, Mairuhu W, Biemond BJ, van Zanten AP, Schnog JJ, Brandjes DP, Otten HM; CURAMA study group. Urinary markers of bone resorption, pyridinoline and deoxypyridinoline, are increased in sickle cell patients with further increments during painful crisis. Am J Hematol. 2010 Nov;85(11):902-4. doi: 10.1002/ajh.21856.
- Miller RG, Segal JB, Ashar BH, Leung S, Ahmed S, Siddique S, Rice T, Lanzkron S. High prevalence and correlates of low bone mineral density in young adults with sickle cell disease. Am J Hematol. 2006 Apr;81(4):236-41. doi: 10.1002/ajh.20541.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vit.D-Bisph-SCD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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