Vitamin D and Bisphosphonates in the Treatment of Sickle Cell Disease
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ClinicalTrials.gov Identifier: NCT02972138 |
Recruitment Status :
Completed
First Posted : November 23, 2016
Last Update Posted : October 6, 2017
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Condition or disease |
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Sickle Cells Disease |
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 : | Observational |
Actual Enrollment : | 80 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Vitamin D Supplementation and Anti-resorptive Therapy (Bisphosphonates) Treatment of Young Adult Patients With Sickle Cell Disease |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | September 2017 |

- Incidence of vertebral fracture [ Time Frame: 5 years follow up ]
- severity of vertebral fracture [ Time Frame: 5 years follow up ]
- Incidence of non-vertebral fracture [ Time Frame: 5 years follow up ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972138
Italy | |
Ospedali Galliera - S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro | |
Genova, Italy, 16128 | |
Ospedali Galliera - S.S.D. Ortogeriatria per intensità di cure | |
Genova, Italy, 16128 | |
Università degli Studi di Verona | |
Verona, Italy, 37129 |
Principal Investigator: | Luca G Dalle Carbonare, MD | Università degli studi di Verona |
Responsible Party: | Società Italiana Talassemie ed Emoglobinopatie |
ClinicalTrials.gov Identifier: | NCT02972138 |
Other Study ID Numbers: |
Vit.D-Bisph-SCD |
First Posted: | November 23, 2016 Key Record Dates |
Last Update Posted: | October 6, 2017 |
Last Verified: | December 2015 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Sickle-cells Disease bisphosphonates Vitamine D |
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |