Comparative Efficacy and Safety Study of RGB-14-P and Prolia in Women with Postmenopausal Osteoporosis
- Conditions
- Postmenopausal osteoporosisMedDRA version: 20.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
- Registration Number
- EUCTR2020-006017-38-ES
- Lead Sponsor
- Gedeon Richter Plc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 434
1. Participant is >/= 60 to 2. Participant is an ambulatory postmenopausal woman, diagnosed with osteoporosis, able to walk and not bedridden. A woman is considered postmenopausal if she meets any of the following criteria:
a. Has 12 months of spontaneous amenorrhea without an alternative medical cause with serum follicle stimulating hormone (FSH) levels falling in the normal postmenopausal range at the central laboratory at the time of the Screening Period.
b. Female participant underwent bilateral oophorectomy (with or without hysterectomy) at least 6 weeks prior to the Screening Period.
3. Participant has an absolute BMD consistent with T score /= 4.0 at the lumbar spine as measured by dual energy X ray absorptiometry (DXA) during the Screening Period and at least 2 lumbar vertebrae (from L1 to L4) must be evaluable by DXA.
4. Participant has body weight >/= 50 and 5. Participant is willing and able to give signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
6. Participant has provided informed consent prior to any study specific activities/procedures.
Participant must meet the following criteria to be enrolled in the Transition Period:
7. Have been enrolled, received both doses of IMP and completed the scheduled Main Period (up to Week 52) of the RGB-14-101 study.
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 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 326
1. Participant has a history and/or presence of one severe or more than two moderate vertebral fractures as determined by central reading of lateral spine X ray during the Screening Period.
2. Participant has a history and/or presence of hip fracture.
3. Participant has a history and/or presence of atypical femur fracture.
4. Participant presents with an active healing fracture according to the assessment of the Investigator.
5. Participant has a bilateral hip replacement (unilateral is allowed if the other hip is evaluable with DXA).
6. Participant has a vitamin D deficiency, the assessment may be repeated once after vitamin D supplementation. Appropriate vitamin D dosing in addition to vitamin D supplementation is permitted at the discretion of the Investigator during the Screening Period.
7. Participant has hypocalcaemia or hypercalcaemia at the Screening Period, the assessment may be repeated once in the case of hypercalcaemia.
8. Participant has a history and/or presence of bone metastases, renal osteodystrophy, osteomyelitis, any metabolic, endocrine or traumatic bone disease (except postmenopausal osteoporosis) that may interfere with the interpretation of the results.
9. Participant has a current uncontrolled status of hypothyroidism or hyperthyroidism.
10. Participant has a history (within 5 years prior to Screening) and/or current hypoparathyroidism or hyperparathyroidism other than clinically not significant secondary hyperparathyroidism.
11. Participant has had major surgery within 8 weeks prior to the Screening Period or planned, anticipated major surgery during the study.
12. Participant has malignancy within 5 years before Screening (except completely cured in situ cervical carcinoma or non metastatic squamous or basal cell carcinoma of the skin).
13. Participant has a history and/or presence of significant cardiac disease or ECG abnormalities indicating significant risk for participating in the study as judged by the Investigator.
14. Participant has a known intolerance or malabsorption of calcium or vitamin D supplements.
15. Participant has a known hypersensitivity (including severe allergic reaction) to monoclonal antibodies or a history of systemic hypersensitivity to any components of the IMPs.
16. Participant shows contraindications to denosumab therapy (e.g., hypocalcaemia), or calcium or vitamin D supplementation before starting IMP administration.
17. Participant has a latex allergy.
18. Participant has a history and/or presence of ONJ or risk factors for ONJ.
19. Participant has history and/or presence of osteonecrosis of the external auditory canal.
20. Participant requiring ongoing use of any osteoporosis treatment (other than calcium and vitamin D supplements).
21. Participant has previously received denosumab or biosimilar denosumab.
22. Participant has previously received any of medicines listed in protocol.
23. Participant is receiving or has received any investigational drug (or is currently using an investigational device) within 3 months before receiving IMP, or at least 10 times the respective elimination half life (whichever period is longer).
24. Participant has weight or girth measurements which may preclude accurate DXA measurements in Investigator’s opinion.
25. Participant has inadequate renal and hepatic function at the Screening Period defined as patient on dialysis or estimated glomerular filtration rate (eGFR) < 30 mL/min (calculated using the modification of diet in renal disease [MDRD] f
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method