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| Name | Class |
|---|---|
| Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | OTHER |
| Instituto Palacios | OTHER |
| Complexo Hospitalario de Ourense | OTHER |
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Non-interventional observational prospective follow-up study of cohorts of patients with Previous diagnosis of Osteoporosis with high risk of fractures, with/without previous fractures and treatment with bone formers (biosimilar or original Teriparatide), who meet all the inclusion criteria and exclusion, with prior information and signing of prior informed consent documents.
Non-interventional observational prospective follow-up study of cohorts of patients with Previous diagnosis of Osteoporosis with high risk of fractures, with/without previous fractures and treatment with bone formers (biosimilar or original Teriparatide), who meet all the inclusion criteria and exclusion, with prior information and signing of prior informed consent documents.
Primary objective:
Verify the clinical effectiveness of Teriparatide Biosimilar under clinical practice conditions real. Compare this clinical effectiveness with original Teriparatide administered under similar conditions of actual clinical practice. Design: Observational cohort study, prospective, multicenter, nationwide. Study population: Patients with a previous diagnosis of Osteoporosis with a high risk of fractures,with/without previous fractures and in treatment with bone formers since before the start of the study. The patients will be distributed into 2 cohorts based on whether they are receiving similar Teriparatide (cohort A) or original Teriparatide (Cohort B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Biosimilar Teriparatide | ||
| B | Original Teriparatide |
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| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness for patients treatment with original | At the different moments of analysis (6, 12 and 24 months of treatment) in each of the treatment groups will be presented. The 95% confidence interval will be calculated for the mean percent change difference between groups. Likewise, the Student's t-test will be calculated for independent samples to assess statistical significance. To determine the fracture rate of any location during the study, the percentage of patients in each of the groups will be calculated descriptively. This proportion of patients will be compared between groups using Pearson's Chi-square test or Fisher's exact test, when applicable. The baseline-final change in biochemical markers of bone remodeling (BRM) between treatment groups will also be evaluated through the Student's t-test for independent samples if they meet the normality parameters or, failing that, its corresponding non-parametric test. (Mann-Whitney U test). . | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Confirm fracture rate in any localization while study is ongoing | In order to determinate fracture rate from any localization, patient´s percentage from each group will be calculated in a descriptive way using: Bone fractures during treatment Falls. | 30 Months |
| Demographic and personal aspects related to the risk of osteoporosis |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with previous diagnosis of Osteoporosis with a high risk of fractures, with/without previous fractures and in treatment with bone formers since before the start of the study. The patients will be distributed into 2 cohorts based on whether they are receiving similar Teriparatide (cohort A) or original Teriparatide (Cohort B).
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| Name | Affiliation | Role |
|---|---|---|
| Santiago Palacios | Instituto Palacios de la Salud de la Mujer. Presidente FHOEMO | Study Director |
| Jose Luis Neyro | Hospital Universitario Cruces. Embajador FHOEMO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Parc Taulí | Barcelona | Spain | ||||
| Hospital Universitario Igualada |
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| Hospital Universitario Central de Asturias |
| OTHER |
| Parc Taulí Hospital Universitari | OTHER |
| Hospital Universitario Fundación Jiménez Díaz | OTHER |
| Hospital Universitario Infanta Leonor | OTHER |
| Hospital Universitario Virgen Macarena | OTHER |
| Hospital d'Igualada | OTHER |
| Alpha Bioresearch S.L. | OTHER |
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age, sex, province of residence, year of diagnosis of OP. |
| 24 Months |
| Risk factor of osteoporosis | As per previous patient´s medical records. Phisician will evaluated risk factor as per clinical practice. This information will be available at Clinical Records for each patients. | 30 Months |
| Previous clinical data | Family history of interest as per clinical practice. This information will be available at Clinical Records for each patients. | 24 Months |
| Anthropometric clinical data | weight and height will be combined to report BMI in kg/m^2 | 24 Months |
| Osteoporosis diagnosis | By BMD; BMD data in CL and hip, measured value in g/cm2 and T-Score value. | 24 Months |
| TBS | TBS value | 24 Months |
| FRAX | FRAX value of hip and major fracture. | 24 Months |
| Bone remodelling biomarkers | Combined information described by: BGP (ng/ml), CTX (ng/ml), NTX (nmol/nmol creatine), P1NP (ng/ml), 25 OH vitamin D (ng/ml), intact PTH (pg/ml), TSH uUl/ml), Testosterone (ng/ml), Estradiol (pg/ml), Calcium (mg/dl), Phosphorus (mg/dl).This information will be collected in 194 patients who were recruited in this study. This information will be collected as per protocol during 30months. Physicians will evaluated this parameters as per clinical practice. | 24 Months |
| Hepatic profile | Combined information described by: SGPT (U/L), SGOT (U/L), Gamma GT (U/L), FA (U/L), BT (mg/dl). This information will be collected in 194 patients who were recruited in this study. This information will be collected as per protocol during 30months. Physicians will evaluated this parameters as per clinical practice. | 24 Months |
| Previous bone fractures | Number and type of previous fractures. | 30 Months |
| Previous treatment for osteoporosis | Previous treatment of osteoporosis indicated as yes or no. This information will be available at Clinical Records for each patients.This information will be collected in 194 patients who were recruited in this study. This information will be collected as per protocol during 30months. Physicians will evaluated this parameters as per clinical practice. | 24 Months |
| Complementary previous treatment for osteoporosis | Previous complementary treatment with Vitamin D and/or Calcium. | 24 Months |
| Security profile | Number of secondary effects. Each secondary effects will be evaluted according to medical criterion.This information will be collected in 194 patients who were recruited in this study. This information will be collected as per protocol during 30months. Physicians will evaluated this parameters as per clinical practice. Day of start/end will be indicated. | 30 Months |
| Bone fractures during treatment | Number of fractures during treatment. | 24 Months |
| Falls | Number of falls during the treatment. | 24 Months |
| Barcelona |
| Spain |
| Hospital 12 de Octubre | Madrid | Spain |
| Hospital de La Princesa | Madrid | Spain |
| Hospital Fundación Jimenez Diaz | Madrid | Spain |
| Hospital Infanta Leonor | Madrid | Spain |
| Instituto Palacio de Madrid | Madrid | Spain |
| Complejo Hospitalario Universitario de Orense | Ourense | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Spain |
| Hospital Virgen Macarena | Seville | Spain |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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