TERIPARATIDE for Osteoporotic vertebral fractures | Osteoporotic hip fracture

Inclusion criteria

• {"criterion_text":"- 1. Women aged > 65 years.\n- 2. Recent (< 3 months) clinical vertebral fragility fracture confirmed by X-ray or recent (< 3 months) hip fragility fracture (femoral neck or trochanteric). \n- 3. Patients who authorize their participation in the study by signing the written informed consent."}

Exclusion criteria

• {"criterion_text":"- 1. Hypercalcaemia.\n- 2. Severe vitamin D deficiency (25-hydroxyvitamin D < 10 ng/ml). If the serum concentration of 25-hydroxyvitamin D is 10-30 ng/ml, the patient may be included, but rapid supplementation with cholecalciferol or calcifediol will be carried out according to standard clinical practice.\n- 3. Primary hyperparathyroidism.\n- 4. Paget's disease of bone.\n- 5. Contraindication to any of the treatments in the study.\n- 6. Unexplained parathyroid hormone (PTH) elevation or alkaline phosphatase (ALP).\n- 7. Previous use of intravenous zoledronate in the 52 weeks before inclusion in the study, intravenous ibandronate or pamidronate in the 3 months before inclusion in the study, denosumab in the 52 weeks before inclusion in the study, or prior use of the parathyroid hormone, teriparatide, another analog hormone or sodium fluoride at therapeutic doses at any time. Previous treatment with other antiosteoporotic drugs is permitted, provided that they are not being taken at the time of inclusion in the study.\n- 8. Having received at least 1 dose of romosozumab at any previous time.\n- 9. Patients who, for any reason (cognitive, socio-economic, etc.), have particular difficulties adhering to treatment\n- 10. Having suffered two or more previous vertebral fractures*\n- 11. Patients who, due to their characteristics and according to the doctor's criteria, could benefit more from treatment for osteoporosis other than those in the study, such as denosumab or zoledronic acid** * in these patients, it might be more justified to treat with teriparatide rather than with bisphosphonates ** denosumab might be preferable in patients with renal insufficiency, documented intolerance or contraindication to oral bisphosphonates, polypharmacy or who prefer subcutaneous administration every 6 months to daily treatment; zoledronic acid may be preferable in patients with documented intolerance or contraindication to oral bisphosphonates, polypharmacy, and bedridden patients or those with severe functional impairment."}

Primary endpoints

• {"endpoint_text":"- The main evaluation criterion will be the percentage of patients with at least one new morphometric vertebral fracture (incident vertebral fractures) or the increase in severity of a known vertebral fracture (vertebral re-fracture) during the 52-week study period. For the diagnosis and grading of vertebral fractures, the Genant semi-quantitative method will be used on thoracic and lumbar radiographs.","definition_or_measurement_approach":"Percentage of patients with ≥1 new morphometric vertebral fracture or increase in severity of known vertebral fracture during 52 weeks; diagnosis and grading by Genant semi-quantitative method on thoracic and lumbar radiographs."}

Secondary endpoints

• {"endpoint_text":"- new morphometric vertebral fractures or increased severity of a known vertebral fracture\n- new clinical vertebral fractures\n- new non-vertebral fractures and new major non-vertebral fractures\n- change in BMD with respect to baseline\n- vertebral pain through the VAS-pain with respect to baseline & evaluation of therapeutic adherence\n- quality of life using the EQ-5D questionnaire with respect to baseline\n- frequency of AEs, SAEs, and AEs leading to treatment discontinuation","definition_or_measurement_approach":"New fractures assessed vs baseline (methods as per protocol); BMD change measured vs baseline (method not specified in JSON); pain measured by VAS; adherence evaluated (by return of used cartridges/ampoules as described in protocol summaries); QoL measured by EQ-5D; AEs/SAEs recorded and counted."}

Spain

Earliest CTIS Part Ii Submission Date

20-02-2025

Latest Decision Or Authorization Date

19-05-2025

Processing Time Days

88

Number Of Sites

20

Number Of Participants

127

Primary sponsor

Full Name

Gedeon Richter Iberica S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain