Biochemical Parameters in Patients Using Teriparatide

LUCRETIU RADU1#, MARA CARSOTE2*, ANCA MIHAELA PREDESCU3, TIBERIU STEFANITA TENEA COJAN4#, BOGDAN SOCEA5, VLAD DUMITRU BALEANU5#, MIHAELA POPESCU6, NINA IONOVICI7, DANA MARIA ALBULESCU8 1 University of Medicine and Pharmacy, Craiova, Department of Hygiene, CFR Hospital of Craiova, Stirbei Voda Str., 200374, Craiova, Romania 2 Carol Davila University of Medicine and Pharmacy Department of Endocrinology, C.I.Parhon National Institute of Endocrinology, 34-38 Aviatorilor Av., 011863,Bucharest, Romania 3 University of Medicine and Pharmacy of Craiova, Faculty of Dentistry Medicine, Histology Department, 2-4 Petru Rares Str., 200349, Craiova, Romania 4 University of Medicine and Pharmacy of Craiova, Department of Surgery, CFR Hospital of Craiova, Stirbei-Voda Str., 200374, Craiova, Romania 5 General Surgery Clinic, Emergency Clinical Hospital Sfantul Pantelimon, 340-342 Pantelimon Road, 021659, Bucharest, Romania 6 University of Medicine and Pharmacy of Craiova, Department of Endocrinology, 2-4 Petru Rares Str., 200349, Craiova, Romania 7 University of Medicine and Pharmacy Craiova, Department of Occupational Medicine, 2-4 Petru Rares Str.,200349, Craiova, Romania 8 University of Medicine and Pharmacy Craiova, Department of Anatomy, County Hospital Craiova, 2-4 Petru Rares Str., 200349, Craiova, Romania

Teriparatide (TPT) is the active 1-34 amino acid sequence with osteoanabolic use for severe osteoporosis. Our aim is to analyze the biochemical and clinical profile of patients treated with TPT based on Romanian protocol. The inclusion and exclusion criteria are based on specific country protocol for TPT 20 µg/day, for 2 years, once in life time based on self administration. This is a transversal study including data of a tertiary centre of endocrinology on patients who signed the informed consent. This is a real life study, of observational type (the intervention meaning the TPT recommendation was done by individual decision of each clinician). Normal total and ionic calcium is associated with low 25-hydroxyvitamin D levels and a mean lumbar Tscore of -3.1±0.7SD. 50% of patients treated with TPT have digestive conditions, less than 10% are first time users, a high severity profile is based on a median of 4 years regarding prior anti-osteoporotic medication and of 3 previous fragility fractures.

Aim of the study
The aim of this study is to analyse the biochemical and clinical profile of patients treated with TPT based on Romanian protocol [18].

Materials and method
This is a transversal study including data of a tertiary centre of endocrinology on patients who signed the informed consent. This is a real life study, of observational type (the intervention meaning the TPT recommendation * email: carsote_m@hotmail.com; Phone: +40744851934 # Authors with equal contribution to the manuscript and share first authorship was done by individual decision of each clinician). The inclusion and exclusion criteria of the patients are based on Romanian protocol for TPT 20 µg/day, for 2 years, once in life time based on self-administration [18]. The baseline assessment was clinical, biochemical, and also based on central DXA (Dual X-Ray Absorptiometry), using a GE Lunar Prodigy device as mentioned in national protocol.
Data were introduced in Excel/SPSS. The parameters were expressed as mean, median, standard deviation, minimum and maximum.

Results and discussions
43 patients were included (female/male ratio was 41/ 2). Baseline parameters of age at TPT start, number of years since menopause and body mass index (BMI) are introduced in table 1. Numerous co-morbidities were identified at baseline as seen in table 2.
The patients were introduced based on Romanian protocol: either de novo, either non-DXA responders, fracture-responders, meaning they lost BMD (Bone Mineral Density under a prior medication for osteoporosis), either non-DXA, non-fracture responders, meaning they lost BMD      The limits of the study are single centre experience and the need of follow-up data.
The strength of the study is the component of real life medicine regarding a particular protocol of an antiosteoporotic drug.

Conclusions
50% of patients treated with PTP have digestive conditions, less than 10% are first time users, a high severity profile is based on a median of 14 years regarding prior anti-osteoporotic medication and of 3 previous fractures.