Comparative Efficacy and Safety Study of RGB-14-P and Prolia in Women With Postmenopausal Osteoporosis

• Status: Recruiting
• Trial end date: 2023-10-30
• Target enrollment: 0
• Participant gender: Female

Summary

This study will be conducted to assess the efficacy, pharmacodynamic (PD), safety, tolerability, and immunogenicity of RGB -14- P compared to US-licensed Prolia® in participants with postmenopausal osteoporosis, in a comparative manner.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gedeon Richter Plc.
• Treatments: Denosumab

Criteria

Inclusion Criteria:

• Participant is an ambulatory postmenopausal woman, diagnosed with osteoporosis, able to walk, and not bedridden

• Participant has an absolute BMD consistent with T score ≤ 2.5 and ≥ 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

• Participant has body weight ≥ 50 and ≤ 90 kg at the Screening Period

Participants must meet the following criteria to be enrolled in the Transition Period:

• Have been enrolled, received both doses of the test drug, and completed the scheduled Main Period (up to Week 52) of the RGB-14-101 study

Exclusion Criteria:

• Participant has a history and/or presence of a severe or more than two moderate vertebral fractures as determined by central reading of lateral spine X-ray during the Screening Period

• Participant has a history and/or presence of hip fracture

• Participant has a history and/or presence of atypical femur fracture

• Participant presents with an active healing fracture

• Participant has a bilateral hip replacement (unilateral is allowed if the other hip is evaluable with DXA)

• Participant has a vitamin D deficiency

• Participant has hypocalcaemia or hypercalcemia at the Screening Period

• Participant has a history and/or presence of bone metastases, renal osteodystrophy, osteomyelitis, any metabolic, endocrine or traumatic bone disease

• Participant has a current uncontrolled status of hypothyroidism or hyperthyroidism

• Participant has a history (within 5 years prior to Screening) and/or current hypoparathyroidism or hyperparathyroidism

• Participant has malignancy within 5 years before Screening

• Participant has a history and/or presence of significant cardiac disease

• Participant has a known intolerance or malabsorption of calcium or vitamin D supplements

• Participant shows contraindications to denosumab therapy (e.g., hypocalcaemia), or calcium or vitamin D supplementation before starting test drug administration

• Participant has a latex allergy

• Participant has a history and/or presence of ONJ or risk factors for ONJ such as invasive dental procedures

• Participant has history and/or presence of osteonecrosis of the external auditory canal

• Participant requiring ongoing use of any osteoporosis treatment

• Participant has previously received denosumab or biosimilar denosumab

• Participant has weight or girth measurements which may preclude accurate DXA measurements

• Participant has an active infection, including, but not limited to severe acute respiratory syndrome coronavirus-2, hepatis B, hepatitis C and human immunodeficiency virus infections during the Screening Period