Efficacy of Zoledronic Acid + Colaren vs Zoledronic Acid + Conventional Treatment for Osteoporosis in HIV+ and HIV- Men
NCT ID: NCT03930992
Last Updated: 2023-12-08
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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COMPLETED
PHASE3
30 participants
INTERVENTIONAL
2019-04-17
2022-10-31
Brief Summary
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Including men with osteoporosis secondary to HIV and men with osteoporosis secondary to any other cause (HIV negative). Vitamin D levels, bone densitometry and markers of metabolism, bone formation and bone resorption will be assessment. The all parameters above will be assessed basally (before the start of treatment), after starting the treatment, an assessment will be made at 12 weeks where vitamin D levels and bone markers will be measured. Meanwhile, at week 24 assess only vitamin D levels; and finally, at week 52 all parameters mentioned above will be measured.
Detailed Description
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Including men with osteoporosis secondary to HIV and men with osteoporosis secondary to any other cause (HIV negative). Vitamin D levels, bone densitometry and markers of metabolism, bone formation and bone resorption will be assessment. The all parameters above will be assessed basally (before the start of treatment), after starting the treatment, an assessment will be made at 12 weeks where vitamin D levels and bone markers will be measured. Meanwhile, at week 24 assess only vitamin D levels; and finally, at week 52 all parameters mentioned above will be measured.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
1. arm: 4 mg zoledronic acid annually plus colaren ® in HIV-positive;
2. arm: 4 mg zoledronic acid annually plus conventional treatment in HIV-positive;
3. arm: 4 mg zoledronic acid annually plus colaren ® in HIV-negative;
4. arm: 4 mg zoledronic acid annually plus conventional treatment in HIV-negative.
TREATMENT
NONE
Study Groups
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1 Arm: Experimental
Experimental: 4 mg zoledronic acid plus colaren ® This arm include: 20 man with HIV infection plus osteoporosis
Colaren in HIV positive
1 Arm (HIV+): will receive Zoledronic acid 4mg and colaren ® (vitamin D, magnesium, phosphate, calcium).
2 Arm: Active comparator
Active comparator: 4mg zoledronic acid + standard treatment (or conventional treatment) This arm include: 20 man with HIV infection plus osteoporosis
standard treatment in HIV positive
2 Arm (HIV+): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate)
3 Arm: Experimental
Experimental: 4 mg zoledronic acid plus colaren ® This arm include: 20 man without HIV infection plus osteoporosis
Colaren in HIV negative
3 Arm (HIV-): will receive Zoledronic acid 4mg and colaren ® (vitamin D, magnesium, phosphate, calcium).
4 Arm: Active comparator
Active comparator: 4mg zoledronic acid + standard treatment (or conventional treatment) This arm include: 20 man without HIV infection plus osteoporosis
standard treatment in HIV negative
4 Arm (HIV-): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate)
Interventions
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Colaren in HIV positive
1 Arm (HIV+): will receive Zoledronic acid 4mg and colaren ® (vitamin D, magnesium, phosphate, calcium).
standard treatment in HIV positive
2 Arm (HIV+): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate)
Colaren in HIV negative
3 Arm (HIV-): will receive Zoledronic acid 4mg and colaren ® (vitamin D, magnesium, phosphate, calcium).
standard treatment in HIV negative
4 Arm (HIV-): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HIV diagnosis (HIV positive group) or negative HIV serology (HIV negative group).
* Patients receiving HAART and sustained virologic control for at least two years.
* Patients meeting diagnostic criteria for osteoporosis.
* Subjects willing to participate voluntarily in this study and give a written consent.
* Estimated glomerular filtration rate \>60 mL/min (Using CKD-EPI formula).
* Female patients.
* Use of immunosuppressive o immunomodulatory treatment 90 days previous to selection.
* Use of prohibited drugs for the study like: antiestrogens, corticosteroids (doses greater than 7.5mg of prednisone/day) 90 days previous to selection.
* Use of hormone therapy.
* Patients with history or actual use of chemotherapy.
* Patients deprived of freedom or imprisoned patients with mental illnesses.
* Participant is part of another clinical trial or nutritional program.
* Hypogonadism diagnosis with not having received hormonal replacement previous to the study.
* Primary osteoporosis diagnosis.
Exclusion Criteria
* Use of herbs or herb products during the last 90 days previous to the study.
* Positive test for HCV or HBV.
* Patients who cannot be submitted to complete examination for variable analysis.
* Glomerular filtration rate \<60 mL/minute.
* Active liver disease.
* Non-compliance to treatment (less than 90%).
* Patients who are not willing to continue participating.
18 Years
65 Years
MALE
No
Sponsors
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Hospital Civil de Guadalajara
OTHER
University of Guadalajara
OTHER
Responsible Party
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Luz Alicia González Hernández
Head of HIV Unit in Hospital Civil de Guadalajara
Locations
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Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Countries
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References
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Wheater G, Elshahaly M, Tuck SP, Datta HK, van Laar JM. The clinical utility of bone marker measurements in osteoporosis. J Transl Med. 2013 Aug 29;11:201. doi: 10.1186/1479-5876-11-201.
Sattui SE, Saag KG. Fracture mortality: associations with epidemiology and osteoporosis treatment. Nat Rev Endocrinol. 2014 Oct;10(10):592-602. doi: 10.1038/nrendo.2014.125. Epub 2014 Aug 5.
Rothman MS, Bessesen MT. HIV infection and osteoporosis: pathophysiology, diagnosis, and treatment options. Curr Osteoporos Rep. 2012 Dec;10(4):270-7. doi: 10.1007/s11914-012-0125-0.
Panayiotopoulos A, Bhat N, Bhangoo A. Bone and vitamin D metabolism in HIV. Rev Endocr Metab Disord. 2013 Jun;14(2):119-25. doi: 10.1007/s11154-013-9246-8.
Leal J, Gray AM, Prieto-Alhambra D, Arden NK, Cooper C, Javaid MK, Judge A; REFReSH study group. Impact of hip fracture on hospital care costs: a population-based study. Osteoporos Int. 2016 Feb;27(2):549-58. doi: 10.1007/s00198-015-3277-9. Epub 2015 Aug 19.
Compston J, Cooper A, Cooper C, Gittoes N, Gregson C, Harvey N, Hope S, Kanis JA, McCloskey EV, Poole KES, Reid DM, Selby P, Thompson F, Thurston A, Vine N; National Osteoporosis Guideline Group (NOGG). UK clinical guideline for the prevention and treatment of osteoporosis. Arch Osteoporos. 2017 Dec;12(1):43. doi: 10.1007/s11657-017-0324-5. Epub 2017 Apr 19.
Bolland MJ, Grey AB, Horne AM, Briggs SE, Thomas MG, Ellis-Pegler RB, Woodhouse AF, Gamble GD, Reid IR. Annual zoledronate increases bone density in highly active antiretroviral therapy-treated human immunodeficiency virus-infected men: a randomized controlled trial. J Clin Endocrinol Metab. 2007 Apr;92(4):1283-8. doi: 10.1210/jc.2006-2216. Epub 2007 Jan 16.
Carlos F, Clark P, Maciel H, Tamayo JA. Direct costs of osteoporosis and hip fracture: an analysis for the Mexican Social Insurance Health Care System. Salud Publica Mex. 2009;51 Suppl 1:S108-13. doi: 10.1590/s0036-36342009000700014.
Other Identifiers
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OSZCO
Identifier Type: -
Identifier Source: org_study_id