Osteoporosis in postmenopausal women at increased risk of fracture. MedDRA version: 21.0 Level: PT Classification code 10031290 Term: Osteoporotic fracture System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Teriparatide biosimilar
Pharmaceutical Form: Solution for injection
Product Name: Alendronic acid
Pharmaceutical Form: Tablet
Sponsors
Gedeon Richter Ibérica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women aged> 65 years. 2. Recent clinical vertebral fracture (=65 years) yes F.1.3.1 Number of subjects for this age range 376
Exclusion criteria
Exclusion criteria: 1. Hypercalcemia. 2. Vitamin D deficiency. If the serum concentration of 25-hydroxyvitamin D is <20 ng / ml (<50 nmol / l), a supplementation with vitamin D will be carried out, according to usual clinical practice, and the analysis may be repeated. in 2-3 months and assess their inclusion. 3. Primary hyperparathyroidism. 4. Paget's disease of bone. 5. Contraindication to any of the study treatments. 6. Unexplained elevation of parathyroid hormone (PTH) or alkaline phosphatase (FA). 7. Prior use of intravenous zoledronate within 52 weeks prior to study enrollment, intravenous ibandronate or pamidronate within 3 months prior to study enrollment, denosumab within 52 weeks prior to study enrollment, or use prior parathyroid hormone, teriparatide, other analogous hormone, or sodium fluoride at therapeutic doses at any time. Pretreatment with other antiosteoporotic drugs is allowed as long as they are not being taken at the time of study inclusion. 8. Have received at least 1 dose of romosozumab at any previous time 9. Patients who for any condition (cognitive, socio-economic, etc ...) present special difficulties in adherence to treatment 10. Having presented two or more previous vertebral fractures * 11. Patients whose characteristics, according to the doctor's criteria, could benefit from more than one treatment for osteoporosis other than those in the study, such as denosumab or zoledronic acid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of biosimilar teriparatide compared to alendronate in reducing the incidence of new morphometric vertebral fractures and / or worsening of previous ones in women older than 65 years with recent clinical vertebral fracture or hip fracture and low bone mineral density. after 52 weeks of treatment.;Secondary Objective: • Incidence of new morphometric vertebral fractures and / or aggravation of prior to 26 weeks of treatment. • Incidence of new clinical vertebral fractures at 26 and 52 weeks. • Incidence of moderate and severe vertebral fractures (grades 2 and 3) at 26 and 52 weeks. • Incidence of multiple vertebral fractures at 26 and 52 weeks. • Incidence of non-vertebral fractures at 26 and 52 weeks. • Incidence of major non-vertebral fractures (proximal humerus, distal radius, and proximal femur) at 26 and 52 weeks. • Changes in BMD (Bone Mineral Density) at 52 weeks. • Changes in TBS (Trabecular Bone Score) at 52 weeks. • Reduction of spinal pain, using a visual analog scale (VAS) at 26 and 52 weeks. • Improvement in quality of life, using the EQ-5D questionnaire at 26 and 52 weeks. • Adherence to treatment throughout the study. • Safety (adverse events).;Primary end point(s): Percentage of patients with at least one new morphometric vertebral fracture (incident vertebral fractures) or increased severity of a known vertebral fracture (vertebral re-fracture);Timepoint(s) of evaluation of this end point: During the 52-week study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Incidence of new morphometric vertebral fractures or the increase in severity of a known vertebral fracture 2. Incidence of new clinical vertebral fractures 3. Incidence of new non-vertebral fractures 4. Incidence of new major non-vertebral fractures 5. Change in bone mineral density from baseline 6. Change in the trabecular bone score with respect to the base value 7. Change in spinal pain via EVA-pain from baseline] 8. Change in quality of life through the EQ-5D questionnaire compared to baseline 9 .Evaluation of therapeutic adherence;Timepoint(s) of evaluation of this end point: 1 Oonset and at 26 weeks. 2. Onset, at 26 and 52 weeks. 3. Onset, at 26 and 52 weeks. 4. Onset, at 26 and 52 weeks. 5. Baseline and at 52 weeks. 6. Start and at 52 weeks. 7. Baseline, at 10, 26, and 52 weeks. 8. Start, at 10, at 26 and at 52 weeks. 9 .Start at 10, 26 and 52 weeks. | — |
Countries
Spain
Contacts
Public ContactMercedes Villa
TRIALANCE
Outcome results
None listed