A study of FKS518 compared to Prolia in Postmenopausal Women with Osteoporosis (LUMIADE-3 Study)

Phase 1

• Conditions: Osteoporosis in Postmenopausal Women; MedDRA version: 20.0Level: HLTClassification code 10005992Term: Bone metabolism disordersSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2020-004422-31-HU
• Lead Sponsor: Fresenius Kabi SwissBioSim GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-29
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 556

Inclusion Criteria

1. Female =55 to =85 years of age, inclusive, at screening.
2. Subject should have confirmed postmenopausal status, defined as
age-related or early/premature amenorrhea =12 consecutive months
and increased follicle-stimulating hormone (FSH) >40 mIU/mL at
screening; or surgical menopause (bilateral oophorectomy with or
without hysterectomy) =12 months prior to screening.
3. Absolute BMD consistent with T-score =-2.5 and =-4.0 at the lumbar
spine as measured by DXA as per central assessment.
4. At least 2 vertebrae in the L1-L4 region and at least 1 hip joint are
evaluable by DXA.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 370
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 186

Exclusion Criteria

1. History and/or presence of 1 severe or >2 moderate vertebral
fractures or hip fracture confirmed by x-ray.
2. Presence of active healing fracture at screening.
3. History and/or presence of bone-related disorders, such as but not limited to Paget's disease, osteomalacia, hyperparathyroidism (or
parathyroid disorders), or renal osteodystrophy.
4. Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive
dental procedures, poor oral hygiene,
periodontal, and/or pre-existing dental disease as assessed by the
Investigator.
5. Prior denosumab (Prolia, Xgeva, or proposed denosumab biosimilar)
exposure.
6. Prior use of fluoride within the 5 years before inclusion in the study.
7. Any current or prior use of strontium ranelate.

Study & Design

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