ACTA FAC MED NAISS 2014;31(1):29-39

Review article

UDC:616.71-007.234

DOI:10.2478/afmnai-2014-0003

New Drugs for Osteoporosis Therapy: A Review of the Clinical Trials Phase 2 and 3

Ivana Tadić¹, Ljiljana Tasić¹, Nada Vujasinović Stupar², Katarina Ilić³, Dejan Stevanović⁴

¹University of Belgrade, Faculty of Pharmacy, Department of Social Pharmacy and Pharmaceutical Legislation, Serbia

²University of Belgrade, School of Medicine, Institute of Rheumatology, Serbia

³University of Belgrade, Faculty of Pharmacy, Department of Pharmacology, Serbia

⁴Department of Psychiatry, General Hospital Sombor, Serbia


summary

Osteoporosis is a chronic disease with increasing incidence that predominantly occurs in female population. There are evidences that bisphosphonates, selective estrogen receptor modulators, denosumab, teriparatide and strontium renalate, prevent vertebral fractures while alendronate, risedronate, zoledronic acid, denosumab and strontium renalate prevent hip fractures. Although these drugs are effective in osteoporosis treatment, their use is limited by their side-effects and low-adherence. The aim of this review article was to compare efficacy of new drugs for osteoporosis currently in phase 2 and 3 clinical trials. After reviewing 57 articles available on PubMed and Scopus databases that evaluated efficacy of osteoporosis medications, 10 papers, that fulfilled the review criteria, were selected for the analysis. Finally, the efficacy of five drugs was compared. Efficacy was evaluated by the values of bone mineral density (BMD) and bone turnover markers (BTM). In all the analyzed articles the BMD increased and changes of BTM were noted. The highest increase of lumbar BMD from the baseline values was achieved after six months of subcutaneous application of 20 μg/day teriparatide (11.3%). The lowest increase of BMD in the same region was recorded after six months of risedronate therapy 100 mg per os once monthly (2.1%). From ten selected articles, only one has reported data about fracture risk.

Keywords: osteoporosis, therapy, efficacy, clinical trials phase 2 and 3