Denosumab Versus Zoledronic Acid in Thalassemia-Induced Osteoporosis
NCT ID: NCT03040765
Last Updated: 2019-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
17 participants
INTERVENTIONAL
2018-05-14
2019-04-08
Brief Summary
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Patients with B-Thalassemia Major induced osteoporosis, who are 18 years of age or more and willing to participate in the study will be enrolled after consenting by the primary investigator in hematology outpatient clinic. Patients with osteoporosis will receive one of the two medications, at the end of the year Dual-energy X-ray absorptiometry scan will be done to compare the response of the two medications. The potential risks include the drug-related side effects
Detailed Description
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OPG acts as a decoy receptor for RANKL and prevents its interaction with RANK thereby inhibiting osteoclast formation, function, and survival. Alteration of the RANK/RANKL/OPG system for increased osteoclastic activity and enhanced osteoblastic dysfunction is proposed as an important mechanism in the etiology of osteoporosis in BTM. Hypogonadism, a common finding in BTM, is associated with enhanced RANKL activity. The sex steroid hormones, androgen, and estrogens, via their respective nuclear receptors, regulate BMD in humans and mice. Testosterone is likely to have direct and indirect inhibitory effects on human osteoclast formation and bone resorption. Animal model and cell culture studies suggest a direct inhibitory effect of androgens on the OPG/RANKL cytokines system. In human osteoblastic cells, testosterone and 5-dihydrotestosterone mediate an androgen receptor-induced specific inhibition of OPG messenger ribonucleic acid (mRNA) expression. Androgens have also been shown to block RANKL-induced osteoclastic formation while RANKL expression was found to be up-regulated in osteoblastic cells from androgen receptor-deficient mice. The effect of oestradiol (E2) on osteoclast precursors and osteoclasts seems to be mediated by osteoblastic cells. Inhibitory effect of E2 is associated with the stimulated secretion of OPG by osteoblasts. Previous studies have focused on the characteristics of thalassemic patients with osteoporosis and their response to therapy with bisphosphonate. Because RANK-RANKL and OPG play a significant role in bone resorption and seem to be the principal implicated mechanism for the development of osteoporosis in BTM, we will conduct this prospective study to evaluate the anti-RANKL denosumab versus zoledronic acid on TM-induced osteoporosis.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Denosumab
Denosumab 60 MG/ML Prefilled Syringe
Denosumab Dose: 60 milligrams, subcutaneous injection, every 6 months (twice a year)
Denosumab 60 MG/ML Prefilled Syringe
Denosumab 60 MG/ML will be administered to 20 patients with b-thalassemia major
Zoledronic Acid
Zoledronic Acid 5Mg/Bag 100Ml Inj
Zoledronic acid will be 5 milligrams, Intravenous injection, once a year
Zoledronic Acid 5Mg/Bag 100Ml Inj
Zoledronic Acid 5Mg/Bag 100Ml Inj will be administered to 20 patients with b-thalassemia major
Interventions
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Denosumab 60 MG/ML Prefilled Syringe
Denosumab 60 MG/ML will be administered to 20 patients with b-thalassemia major
Zoledronic Acid 5Mg/Bag 100Ml Inj
Zoledronic Acid 5Mg/Bag 100Ml Inj will be administered to 20 patients with b-thalassemia major
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 years old or older
* Eastern Cooperative Oncology Group Performance Status less than or equal 2
Exclusion Criteria
* Not willing to participate in the study
* Vulnerable subjects or Eastern Cooperative Oncology Group Performance Status 3 or 4
18 Years
ALL
No
Sponsors
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Hamad Medical Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mohamed Yassin
Role: PRINCIPAL_INVESTIGATOR
Hamad Medical Corporation
Locations
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National Center for Cancer Care & Research (NCCCR)
Doha, , Qatar
Countries
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References
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Other Identifiers
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16441/16
Identifier Type: -
Identifier Source: org_study_id