Conditions: Postmenopausal Osteoporosis
Keywords: postmenopausal osteoporosis osteoporosis postmenopausal denosumab women
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 394
Healthy volunteers: no

Brief summary:
This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.

Detailed description:

Arms:
arm 1: Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year. arm 2: Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.

Interventions: intervention 1: Denosumab (CP2) intervention 2: Denosumab (CP4)
Intervention descriptions: intervention 1: Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe. intervention 2: Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.

Protocol document: