NCT03930992 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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 contr
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.
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 treatme
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
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.
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.
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.
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.

Efficacy of 4 mg Zoledronic Acid Plus Colaren vs 4mg Zoledronic Acid + Conventional Treatment for Secondary Osteoporosis in HIV Positive and Negative Men

Details for clinical trial NCT03930992

Clinical trial NCT03930992 - References