A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.

Korábbi kezelés

• Previous exposure to denosumab (Prolia®, Xgeva®, or denosumab biosimilar) or other monoclonal antibody.
• Oral bisphosphonates ≥12 months cumulative use prior to screening. If used <12 months cumulatively and the last dose was ≥12 months before screening, the subject could be enrolled.
• Other bone active drugs.

Más betegség

• History and/or presence of bone metastases, bone disease or other metabolic disease.

Egyéb

• History and/or presence of one severe or more than two moderate vertebral fractures or hip fracture.
• Recent long bone fracture (within 6 months).
• Intravenous bisphosphonate administered within 5 years of screening.
• Ongoing use of any osteoporosis treatment or use of prohibited treatment.
• History and/or current hypoparathyroidism or hyperparathyroidism, hypocalcemia or hypercalcemia.
• Other Inclusion/exclusion criteria may apply.

• Postmenopausal women, diagnosed with osteoporosis.
• Aged ≥ 55 and ≤ 80 years at screening.
• Body weight ≥ 50 kg and ≤ 99.9 kg, and a body mass index of ≤30 kg/m2 at screening.
• Absolute bone mineral density consistent with T-score ≤ -2.5 and ≥ -4.0 at the lumbar spine or total hip as measured by Dual-energy X-ray Absorptiometry (DXA).
• At least two intact, nonfractured vertebrae in the L1-L4 region and at least one hip joint evaluable by DXA.
• Adequate organ function.