scholarly journals Effects of teriparatide in postmenopausal women with osteoporosis pre-treated with bisphosphonates: 36-month results from the European Forsteo Observational Study

2012 ◽  
Vol 166 (1) ◽  
pp. 87-97 ◽  
Author(s):  
F Jakob ◽  
H Oertel ◽  
B Langdahl ◽  
O Ljunggren ◽  
A Barrett ◽  
...  
Keyword(s):  
Back Pain ◽  
Observational Study ◽  
Postmenopausal Women ◽  
Repeated Measures ◽  
Bisphosphonate Therapy ◽  
Teriparatide Treatment ◽  
Routine Clinical Setting ◽  
Pain Visual Analog Scale ◽  
Clinical Fractures

ObjectivesTo describe fracture rates, back pain, and health-related quality of life (HRQoL) in postmenopausal women with osteoporosis and prior bisphosphonate therapy, treated with teriparatide for up to 18 months and followed up for a further 18 months.DesignProspective, multinational, and observational study.MethodsData on prior bisphosphonate use, clinical fractures, back pain visual analog scale (VAS), and HRQoL (EQ-5D) were collected over 36 months. Fracture data were summarized in 6-month intervals and analyzed using logistic regression with repeated measures. Changes from baseline in back pain VAS and EQ-VAS were analyzed using a repeated measures model.ResultsOf the 1581 enrolled patients with follow-up data, 1161 (73.4%) had a history of prior bisphosphonate use (median duration: 36 months). Of them, 169 (14.6%) sustained ≥1 fracture during 36-month follow-up. Adjusted odds of fracture were significantly decreased at each 6-month interval compared with the first 6 months of teriparatide treatment: 37% decrease in the 12 to <18 months period during teriparatide treatment (P=0.03) and a 76% decrease in the 12- to 18-month period after teriparatide was discontinued (P<0.001). Significant reductions in back pain and improvement in HRQoL were observed.ConclusionsPostmenopausal women with severe osteoporosis previously treated with bisphosphonates had a significant reduction in the incidence of fractures compared with the first 6 months of therapy, a reduction in back pain and an improvement in HRQoL during up to 18 months of teriparatide treatment. These outcomes were still evident for at least 18 months after teriparatide was discontinued. The results should be interpreted in the context of an uncontrolled, observational study in a routine clinical setting.

Effectiveness of Teriparatide in Postmenopausal Women with Osteoporosis and Glucocorticoid Use: 3-Year Results from the EFOS Study

2012 ◽  
Vol 39 (3) ◽  
pp. 600-609 ◽  
Author(s):  
DIMITRIOS KARRAS ◽  
IVAYLO STOYKOV ◽  
WILLEM F. LEMS ◽  
BENTE L. LANGDAHL ◽  
ÖSTEN LJUNGGREN ◽  
...  
Keyword(s):  
Back Pain ◽  
Observational Study ◽  
Postmenopausal Women ◽  
Repeated Measures ◽  
Study Data ◽  
Teriparatide Treatment ◽  
Routine Clinical Setting ◽  
Related Quality ◽  
Health Related ◽  
Clinical Fractures

Objective.To describe clinical fracture rates, back pain, and health-related quality of life (HRQOL) in postmenopausal women with osteoporosis who are receiving glucocorticoids (GC), during a 36-month study of teriparatide treatment for up to 18 months, with an additional 18-month followup period when patients were receiving other osteoporosis medications.Methods.A prospective, multinational, observational study. Data for clinical fractures, back pain (by visual analog scale; VAS) and HRQOL (by EQ-5D) were collected over 36 months. Fracture data were summarized in 6-month segments and analyzed using logistic regression with repeated measures. Changes from baseline in back pain VAS and EQ-VAS were analyzed.Results.Of 1581 enrolled women with followup data, 294 (18.6%) had antecedents of GC use. Of these, 49 (16.7%) patients sustained a total of 69 fractures during the 36-month study period. Adjusted odds of fracture were significantly decreased during the last year of followup compared with the first 6 months of teriparatide treatment: an 81% decrease in the 24 to < 30-month period (p < 0.05), and an 89% decrease in the 30 to < 36-month period (p < 0.05). There were significant reductions in back pain and improvements in HRQOL in both groups of GC users and nonusers.Conclusion.Postmenopausal women with severe osteoporosis receiving GC, who were treated with teriparatide for up to 18 months, showed a reduced incidence of clinical fractures during the third year while receiving sequential osteoporosis treatments compared with the first 6 months, together with reduced back pain and improved HRQOL. Our results should be interpreted in the context of an uncontrolled observational study in a routine clinical setting.

scholarly journals The Effect of Teriparatide Treatment on the Risk of Fragility Fractures in Postmenopausal Women with Osteoporosis: Results from the Asian and Latin America Fracture Observational Study (ALAFOS)

2021 ◽  
Author(s):  
Chung-Hwan Chen ◽  
Abdulaziz H. Elsalmawy ◽  
Sophia Ish-Shalom ◽  
Seung-Jae Lim ◽  
Nadia S. AlAli ◽  
...  
Keyword(s):  
Latin America ◽  
Back Pain ◽  
Observational Study ◽  
Postmenopausal Women ◽  
Repeated Measures ◽  
Mixed Model ◽  
Real Life ◽  
Fragility Fractures ◽  
Teriparatide Treatment ◽  
Clinical Fractures

AbstractThe Asian and Latin America Fracture Observational Study (ALAFOS) is a prospective, observational, single-arm study conducted in 20 countries across Asia, Latin America and the Middle East. ALAFOS evaluated new clinical vertebral and non-vertebral fragility fractures in relation to time on teriparatide, in postmenopausal women with osteoporosis in real-life clinical practice. Clinical fragility fractures, back pain, and health-related quality of life (HRQoL) were recorded in 6-month intervals for ≤ 24 months during teriparatide treatment and up to 12-months post-treatment. Data were analysed with piecewise exponential regression with inverse probability weighting for time to event outcomes and mixed-model repeated measures for back pain and HRQoL. 3054 postmenopausal women started teriparatide and attended ≥ one follow-up visit (mean [SD] age 72.5 [10.4] years). The median (95% CI) time to treatment discontinuation was 22.0 months (21.2, 22.8). During the treatment period, 111 patients (3.6%) sustained 126 clinical fractures (2.98 fractures/100 patient-years). Rates of new clinical fragility fractures were significantly decreased during the > 6–12, > 12–18, and > 18–24-month periods, as compared with the first 6 months of treatment (hazard ratio [HR] 0.57; 95% CI 0.37, 0.88; p = 0.012; HR 0.35; 95% CI 0.19, 0.62; p < 0.001; HR 0.43; 95% CI 0.23, 0.83; p = 0.011; respectively). Patients also reported an improvement in back pain and HRQoL (p < 0.001). These results provide data on the real-world effectiveness of teriparatide in the ALAFOS regions and are consistent with other studies showing reduction of fractures after 6 months of teriparatide treatment. These results should be interpreted in the context of the noncontrolled design of this observational study.

scholarly journals Combination of caudal epidural steroids with oral gabapentin for radicular low back pain: a prospective observational study

2019 ◽  
Vol 5 (1) ◽  
pp. 5-10
Author(s):  
Grisuna Singh ◽  
Binod Thapa ◽  
Kiran Gurung ◽  
Nirmal Gyawali
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Observational Study ◽  
Prospective Observational Study ◽  
Low Back ◽  
Socioeconomic Condition ◽  
Psychological Burden ◽  
Epidural Steroids ◽  
Caudal Epidural

Introduction: The physical, socioeconomic and psychological burden of low back pain is enormous. The poor socioeconomic condition and geographical constrains confines people to limited health facilities. The objective of the study was to evaluate whether combination of caudal epidural steroids with local anaesthetics and gabapentin is effective for radicular low back pain in the rural Nepal setting. Methods: It was a prospective observational study including 300 patients with radicular low back pain done over a period of 6 months (13/4/2016 to 30/10/2016). All participants received caudal epidural steroid injection (6ml 2% Xylocaine with adrenaline plus Depomedroxy steroid 80mg plus 12 ml distilled water) and 200 mg gabapentin daily for three months. All patients were followed up for three months and were evaluated. Results: Mean age of presentation was 41.21 years (SD ± 11.02) with majority of farmers (42.31%). Mean Numerical Rating Scale at the baseline was 8.01(SD±1.00) and at the first follow up was 3.98 (SD±0.83) (p <0.001). Mean Oswestry Disability Index at baseline was7.85 (SD±0.98) and at the first follow up was 4.04 (SD±0.80) (p <0.001). Straight Leg Raising Test at baseline was less than 70° in 84.7% which improved to more than 70° in 87.9% of the patients (p-value <0.001). Conclusion: Caudal epidural steroids combined with gabapentin is safe, economical and technically less demanding. This treatment modality can be used with good outcomes in the rural areas with limited diagnostic and therapeutic facilities.

Final results of 18-month follow-up of Greek women concluding teriparatide treatment in the European Forsteo Observational Study (EFOS)

Bone ◽  
2011 ◽  
Vol 48 ◽  
pp. S223
Author(s):  
K. Aloumanis ◽  
V. Drossinos ◽  
A. Polydorakis ◽  
I. Lasithiotakis ◽  
I. Notaras ◽  
...  
Keyword(s):  
Observational Study ◽  
Teriparatide Treatment

Abstract #30: Duration of Teriparatide Treatment Corresponds with Back Pain Reduction in Postmenopausal Women With Osteoporosis

2004 ◽  
Vol 10 ◽  
pp. 10
Author(s):  
Rachel Wagman ◽  
Clifford J. Rosen ◽  
John Krege ◽  
Peiqi Chen ◽  
Richard Wasnich
Keyword(s):  
Back Pain ◽  
Postmenopausal Women ◽  
Pain Reduction ◽  
Teriparatide Treatment

Considerations on Thermal Behaviour and Porosity of Renal Calculi in Bisphosphonate -Treated Postmenopausal Women

2017 ◽  
Vol 68 (6) ◽  
pp. 1259-1263
Author(s):  
Rodica Narcisa Tanasescu ◽  
Razvan Bardan ◽  
Adriana Ledeti ◽  
Ionut Ledeti ◽  
Petru Matusz ◽  
...  
Keyword(s):  
Postmenopausal Women ◽  
Renal Stones ◽  
Renal Calculi ◽  
Bisphosphonate Therapy ◽  
Calcium Balance ◽  
Exclusion Criteria ◽  
Specific Effects ◽  
Stone Formers ◽  
Decomposition Processes

A longitudinal, randomized, five year follow-up clinical and experimental study was conducted during May 1, 2011 - June 30, 2016. A number of 125 eligible postmenopausal women (BMD T-score spine (-2.8 � 0.5)); BMD at the femoral hip (-2.6 � 0.8), treated only with biphosphonates, were enrolled in the study. The patient�s age ranged between 60 and 65 years. All the women were stone formers, with more than five episodes of crystalluria in the last five years. Exclusion criteria: kidney chronic diseases, use of drugs known to affect bone metabolism and renal function, patients with multi-morbidities. The aim of our study was to assess the connection between postmenopausal osteoporosis and the risk of worsening calcium balance in urolithiasis, based on the complex thermogravimetric findings and porosity studies of renal stones eliminated by these patients. The study of renal-urinary concretions offers the possibility to amplify the specific effects of the thermal decomposition processes of substances, reflecting the sample�s global composition. The research of calculi porosity gives information about the dissolution possibilities of the renal-urinary concretions. In conclusion, in postmenopausal women, proper administration of bisphosphonate therapy must accompany the supplementary medication with calcium and vitamin D, always correlated to the metabolic status of the osteoporotic patient.

Symptom Burden in Extensive Disease Small Cell Lung Cancer (ED-SCLC): A prospective, observational study in U.S. community practices.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 196-196
Author(s):  
Donald A. Richards ◽  
Maen A. Hussein ◽  
Steven L. McCune ◽  
Brian Kent Ulrich ◽  
Mark D. Danese ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Health Status ◽  
Observational Study ◽  
Repeated Measures ◽  
Prospective Observational Study ◽  
Symptom Burden ◽  
Patient Reported ◽  
Lung Cancer Symptom Scale ◽  
Line Of Therapy

196 Background: There is a paucity of data describing the effect of treatment on symptom burden and health status for patients with ED-SCLC receiving care in US community oncology centers. This study explores ED-SCLC patient-reported outcomes independently for either first-line (1L), second-line (2L) or third-line (3L) therapy. Methods: CA209-118 is a prospective observational study of adult patients with lung cancer, including patients with ED-SCLC, in 70 US community practices enrolled between 2014-2017. Participants completed the Lung Cancer Symptom Scale (LCSS) and Euro-QoL 5-D (EQ-5D) utility index and visual analog scale (VAS) at the start of 1L, 2L, or 3L treatment and at follow-up visits. The LCSS is summarized in 3 scales: LCSS total scale which ranges from 0 – 100, average symptom burden scale (ASBI) ranging from 0 – 100, and a three-item global scale (3-IGI) ranging from 0 – 300 (lower scores reflect reduced burden). The EQ-5D scale is a preference based measure of health status with higher scores reflecting better quality and ranges from 0 to 1.0 (index) or 0 – 100 (VAS). LCSS and EQ-5D values at 60 days were predicted in a repeated measures model for patients having a score at baseline and at least 1 follow-up. Results: The mean LCSS and EQ-5D scores at the start of each line of therapy and predicted 60 day change are presented in the table . 60-day improvement was observed only for appetite and cough in 1L. A slight declining trend was seen in 2L and 3L. Conclusions: Patients with ED-SCLC treated in the community reported a high symptom burden at the start of each line of therapy which did not diminish throughout 60 days of treatment. [Table: see text]

Characterization of patients in the European Forsteo Observational Study (EFOS): postmenopausal women entering teriparatide treatment in a community setting

2007 ◽  
Vol 24 (2) ◽  
pp. 377-384 ◽  
Author(s):  
Gerald Rajzbaum ◽  
Franz Jakob ◽  
Dimitrios Karras ◽  
Östen Ljunggren ◽  
Willem F. Lems ◽  
...  
Keyword(s):  
Observational Study ◽  
Postmenopausal Women ◽  
Community Setting ◽  
Teriparatide Treatment

scholarly journals Long-Term Follow-Up of Accelerated Transepithelial Corneal Crosslinking for Post-LASIK Ectasia: A Pilot Prospective Observational Study

2021 ◽  
Vol 9 ◽  
Author(s):  
Mi Tian ◽  
Xiaoyu Zhang ◽  
Weijun Jian ◽  
Ling Sun ◽  
Yang Shen ◽  
...  
Keyword(s):  
Observational Study ◽  
Repeated Measures ◽  
Prospective Observational Study ◽  
Statistical Significance ◽  
Corneal Thickness ◽  
Corneal Crosslinking ◽  
Epithelial Thickness ◽  
Long Term Follow Up

Background: Keratectasia after corneal refractive surgery is a rare but serious postoperative complication, and reports on accelerated transepithelial corneal crosslinking (ATE-CXL)-based treatment of patients with post-laser-assisted in situ keratomileusis (LASIK) ectasia are limited. Therefore, this study evaluated the long-term efficacy and safety of ATE-CXL for progressive post-LASIK ectasia.Methods: This prospective observational study was conducted at the Eye and ENT Hospital, Fudan University, Shanghai, China, and 25 eyes from 25 patients with post-LASIK ectasia undergoing ATE-CXL were examined. Clinical examinations were conducted preoperatively and postoperatively to assess parameters such as manifest refraction, corrected distance visual acuity (CDVA), endothelial cell density; keratometry, corneal thickness, posterior elevation and topometric indices were measured using Pentacam; sectoral pachymetry and epithelial thickness were evaluated using optical coherence tomography. A paired t-test, Wilcoxon rank-sum test, Kruskal-Wallis test, and repeated measures analysis of variance were used for statistical analysis.Results: Participants were examined for an average of 46 months. No severe complications occurred during or after ATE-CXL. CDVA improved from 0.25 ± 0.31 preoperatively to 0.15 ± 0.17 postoperatively (p = 0.011). Maximum keratometry decreased from 55.20 ± 8.33 D to 54.40 ± 7.98 D, with no statistical significance (p = 0.074), and the central corneal thickness increased from 414.92 ± 40.96 μm to 420.28 ± 44.78 μm (p = 0.047) at the final follow-up. Posterior elevation, pachymetry, and epithelial thickness remained stable (p &gt; 0.05) throughout the follow-up. No significant differences were noted in topometric indices, except the central keratoconus index, which decreased significantly (p &lt; 0.001) at the final follow-up.Conclusion: Improvements in CDVA and stabilization in corneal keratometry and posterior elevation after ATE-CXL were noted at the 46-months follow-up, demonstrating that ATE-CXL is a safe and effective treatment for progressive post-LASIK ectasia.

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