IMMINENT study_Osteoporosis

Phase 1

• Conditions: Osteoporosis in postmenopausal women at increased risk of fracture.; MedDRA version: 21.0Level: PTClassification code 10031290Term: Osteoporotic fractureSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2020-005712-22-ES
• Lead Sponsor: Gedeon Richter Ibérica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-23
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 376

Inclusion Criteria

1. Women aged> 65 years.
2. Recent clinical vertebral fracture (<3 months) confirmed by radiography or recent hip (femoral neck or pretrochanteric) fracture (<3 months).
3. Low bone mineral density (BMD) (define by T-score = -1 in lumbar spine, femoral neck or total hip).
4. Patients who authorize their participation in the study by signing the written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 376

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified