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Objective To estimate the proportion of patients with very severe osteoporosis (those covered by the reimbursement criteria of the Italian National Health Service) experiencing new vertebral and non-vertebral fragility fractures in the first 24 months of a new anti-osteoporosis treatment. Methods Prospective observational study in men and post-menopausal women (aged > 21 years) initiating anti-osteoporosis treatment for very severe osteoporosis. Eligibility was based on teriparatide (TPD) reimbursement criteria in Italy: Incident of vertebral or hip fracture during anti-resorptive treatment (minimum 1 year), or at least three prevalent severe vertebral fractures, or two prevalent severe vertebral fractures and a historical proximal hip fracture. Incidence of new clinical vertebral and non-vertebral fractures was documented by original x-rays and/or radiological reports, and a post-hoc analysis compared data from the TPD monotherapy population versus the total treated group. Results Overall, 767 patients (mean age 72.8 years, 90.7% women) were enrolled in the study, of whom 628, 538, 419 and 424 attended visits at 6, 12, 18 and 24 months, respectively. The most commonly prescribed therapy was TPD (single-agent; 64.5%), then bisphosphonates and other anti-resorptives (33.3%). A combination of different oral treatments was given to 22.5% of the patients. Overall treatment adherence at 24 months was 65.7%. In a post-hoc analysis, the overall incidence of new clinical vertebral and non-vertebral fractures in the total treated population was, respectively, 4.7% and 2.3% in the first 6 months; 1.8% and 1.6% in the 6-12 month period; 2.9% and 1.4% in the 12-18 month period; and 2.2% and 1.0% in the 18-24 month period. Conclusion In patients with very severe osteoporosis, the risk of new vertebral and non-vertebral fractures declined after the first 6 months and remained low throughout the study. Objective To estimate the proportion of patients with very severe osteoporosis (those covered by the reimbursement criteria of the Italian National Health Service) experiencing new vertebral and non-vertebral fragility fractures in the first 24 months of a new anti-osteoporosis treatment. Methods Prospective observational study in men and post-menopausal women (aged > 21 years) initiating anti-osteoporosis treatment for very severe osteoporosis. Eligibility was based on teriparatide (TPD) reimbursement criteria in Italy: Incident of vertebral or hip fracture during anti-resorptive treatment (minimum 1 year), or at least three prevalent severe vertebral fractures, or two prevalent severe vertebral fractures and a historical proximal hip fracture. Incidence of new clinical vertebral and non-vertebral fractures was documented by original x-rays and/or radiological reports, and a post-hoc analysis compared data from the TPD monotherapy population versus the total treated group. Results Overall, 767 patients (mean age 72.8 years, 90.7% women) were enrolled in the study, of whom 628, 538, 419 and 424 attended visits at 6, 12, 18 and 24 months, respectively. The most commonly prescribed therapy was TPD (single-agent; 64.5%), then bisphosphonates and other anti-resorptives (33.3%). A combination of different oral treatments was given to 22.5% of the patients. Overall treatment adherence at 24 months was 65.7%. In a post-hoc analysis, the overall incidence of new clinical vertebral and non-vertebral fractures in the total treated population was, respectively, 4.7% and 2.3% in the first 6 months; 1.8% and 1.6% in the 6-12 month period; 2.9% and 1.4% in the 12-18 month period; and 2.2% and 1.0% in the 18-24 month period. Conclusion In patients with very severe osteoporosis, the risk of new vertebral and non-vertebral fractures declined after the first 6 months and remained low throughout the study.

Objective Baseline characteristics of the population enrolled in the ISSO study, designed to evaluate the incidence of vertebral and non-vertebral fractures in Italian patients with severe osteoporosis treated according to clinical practice over 24 months observation. Methods Prospective observational study in 783 post-menopausal women and men entering 18-month treatment with teriparatide in a community setting at 57 centres in Italy. Characterisation included demographics, fracture risk factors, hone mineral density, fracture status, Health-Related Quality of Life (HRQoL) measured by the European Quality of Life Questionnaire, EQ-5D, and back pain assessed by VAS. Results Most patients were elderly women (90.5%), mean age +/- SD was 72.9 +/- 8.8 years. Nearly all (91.3%) had experienced >= 1 vertebral fracture (mean +/- SD, 3.6 +/- 2.2 per patient), 37.5% had >= 1 non-vertebral fracture (mean +/- SD, 1.4 +/- 0.7 per patient). Nearly all patients were suffering from back pain (94.9%), which had significantly restricted their daily activities (51.7%) and had likely or very likely been caused by vertebral fractures (29.2% and 55.8%, respectively). Mean EuroQoL EQ-5D index value was 0.58 +/- 0.25 and VAS score 49.2 +/- 23.6. Non-vertebral fractures, back pain and multiple vertebral fractures were associated with lower HRQoL (EuroQoL-5D Index both p

Teriparatide has an anabolic effect on bone tissue, leading to an increase in bone strength with a reduction in the risk of fragility fractures in osteoporotic women. In the last ten years, many animal studies have been conducted to support the hypothesis that this anabolic effect of teriparatide may benefit fracture healing by reducing the time of callus formation and remodeling. Teriparatide also seems to have an effect in the early post-operative period after osteosynthesis or joint replacement, by stimulating new bone formation, increasing bone-implant contact as early as after 1 week, and enhancing the tensile strength of the bone-cement interface, thereby decreasing the risk of late aseptic loosening. Scientific evidence supports the hypothesis that teriparatide may represent a huge resource for wide applications in orthopedic surgery.

INTRODUCTION: Vertebral fractures have been associated with back pain, functional limitations and reduced health-related quality of life (HRQoL). Teriparatide is the first effective anabolic agent that demonstrated to significantly reduce the risk of vertebral fracture by 65%, as compared to placebo. The aims of this study were to evaluate the effectiveness of teriparatide treatment on back pain-related functional limitations and to investigate on patients HRQoL. MATERIALS AND METHODS: In this prospective observational pilot study osteoporotic patients, who were prescribed teriparatide therapy and a supplementation of calcium and vitamin D, were asked to answer to two self-administered questionnaires: the Spine Pain Index (SPI) and the SF-12 (at the recruitment, after 6, 12, and 18 months). RESULTS: Fifty-two women were evaluated (mean age of 70.58 yrs). The mean SPI score passed from 50.01 at baseline to 32.20 at 18 months. The mean SF-12 PCS score passed from 30.00 at baseline to 36.79 at 18 months, while the mean SF-12 MCS score was already within the normality range at baseline, constantly improving during the 18 months. CONCLUSION: In conclusion, 18 months of treatment with teriparatide has to be considered an effective therapeutic option for women with severe osteoporosis and vertebral fractures, in a real-life clinical setting, to improve both back pain related disability and quality of life.

The patient, a 79-year-old woman with a history of osteoporosis, presented with acute back pain without trauma, three years ago. Spinal X rays showed a vertebral compression fracture at T7, and DXA indicated a T-score of -2.65 BMD at the total hip. The patient started treatment with alendronate 70 mg once a week, plus calcium and vitamin D supplementation. After two years, she presented new acute back pain, and spinal X-rays revealed new vertebral compression fractures at T8 and T11. In September 2004, she stopped alendronate therapy and began teriparatide 20 microg subcutaneously each day for 18 months, associated with a dose of 1200 mg/day of calcium and 880 IU/day of vitamin D. In July 2005, she fell and sustained a fracture of the left proximal humerus. She was treated with conservative therapy and continued teriparatide therapy. After 25 days of conservative management, left shoulder X-ray showed quick formation of fracture healing. In conclusion, although teriparatide is indicated for the treatment of severe osteoporosis and not to enhance fracture healing, there are many experimental data which indicate that it may be beneficial also in enhancing fracture healing. The patient, a 79-year-old woman with a history of osteoporosis, presented with acute back pain without trauma, three years ago. Spinal X rays showed a vertebral compression fracture at T7, and DXA indicated a T-score of -2.65 BMD at the total hip. The patient started treatment with alendronate 70 mg once a week, plus calcium and vitamin D supplementation. After two years, she presented new acute back pain, and spinal X-rays revealed new vertebral compression fractures at T8 and T11. In September 2004, she stopped alendronate therapy and began teriparatide 20 microg subcutaneously each day for 18 months, associated with a dose of 1200 mg/day of calcium and 880 IU/day of vitamin D. In July 2005, she fell and sustained a fracture of the left proximal humerus. She was treated with conservative therapy and continued teriparatide therapy. After 25 days of conservative management, left shoulder X-ray showed quick formation of fracture healing. In conclusion, although teriparatide is indicated for the treatment of severe osteoporosis and not to enhance fracture healing, there are many experimental data which indicate that it may be beneficial also in enhancing fracture healing.

Objective To estimate the proportion of patients with very severe osteoporosis (those covered by the reimbursement criteria of the Italian National Health Service) experiencing new vertebral and non-vertebral fragility fractures in the first 24 months of a new anti-osteoporosis treatment. Methods Prospective observational study in men and post-menopausal women (aged > 21 years) initiating anti-osteoporosis treatment for very severe osteoporosis. Eligibility was based on teriparatide (TPD) reimbursement criteria in Italy: Incident of vertebral or hip fracture during anti-resorptive treatment (minimum 1 year), or at least three prevalent severe vertebral fractures, or two prevalent severe vertebral fractures and a historical proximal hip fracture. Incidence of new clinical vertebral and non-vertebral fractures was documented by original x-rays and/or radiological reports, and a post-hoc analysis compared data from the TPD monotherapy population versus the total treated group. Results Overall, 767 patients (mean age 72.8 years, 90.7% women) were enrolled in the study, of whom 628, 538, 419 and 424 attended visits at 6, 12, 18 and 24 months, respectively. The most commonly prescribed therapy was TPD (single-agent; 64.5%), then bisphosphonates and other anti-resorptives (33.3%). A combination of different oral treatments was given to 22.5% of the patients. Overall treatment adherence at 24 months was 65.7%. In a post-hoc analysis, the overall incidence of new clinical vertebral and non-vertebral fractures in the total treated population was, respectively, 4.7% and 2.3% in the first 6 months; 1.8% and 1.6% in the 6-12 month period; 2.9% and 1.4% in the 12-18 month period; and 2.2% and 1.0% in the 18-24 month period. Conclusion In patients with very severe osteoporosis, the risk of new vertebral and non-vertebral fractures declined after the first 6 months and remained low throughout the study.

Introduction. Osteoporosis is a chronic condition leading to an increased risk of developing fractures, with high morbidity and mortality in aging population. Efficacy of anti-osteoporotic treatment is based on drug potency but also on compliance and persistence to treatment regimen, which is very low, as already described for other diseases. Teriparatide (TPTD) is the first anabolic agent developed for the treatment of osteoporosis. Since it appears that persistence to Teriparatide declines over time, aim of this pilot multicenter observational study was to evaluate persistence and adherence to TPTD (20 μg daily injection regimen for 18 months) treatment (PATT) in patients affected by severe osteoporosis in an every day clinical practice. Methods. Patients affected by severe osteoporosis were selected among those who referred to 5 different specialized centers for osteoporosis in North, Center and South of Italy. A sample of 475 women with severe postmenopausal osteoporosis treated with TPTD in accordance to the Italian osteoporosis guidelines was included. At the beginning of TPTD treatment patients were instructed on the use of the device by the referring specialist of the center, a resident fellow or a nurse. Bone biochemical markers were evaluated the same morning and after 1, 3, 6, 12 and 18 months. Patients were visited at time 0 and after 6, 12 and 18 months for clinical follow up. Results. The results included observations of 441/475 patients (98% women) who completed the 18 months treatment; mean age for women was 73±8 and for men 65±9. After 6 months of TPTD treatment persistence was of 89,79%, 87,75% after 12 months and 86,85% after 18 months. Adherence was of 100% at 6,12 and 18 months. Total dropouts were 13,15% (71/441), which was usually higher within the first 6 months of TPTD treatment. Most common adverse events (arthralgies 2,7%, dizziness 1,8%, migraine 1,8%, depression 1,6%, hypertension 1,1%) were reported in 62/441 patients (14%) of patients, but were not reason for stopping treatment. Conclusions. The persistence and adherence to TPTD treatment obtained in this multicenter observational real life study was very high as compared to studies performed by others. These encouraging results suggest that different key factors such quality of information, frequency of visits, motivations given to patients, opportunity to call the doctor might play a pivotal role in the high persistence and adherence to TPTD treatment obtained in our study and need to be carefully considered before prescribing chronic anti-osteoporotic therapy