A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

Amgen

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Denosumab (CP4); Drug: Denosumab (CP2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02157948

2013-001279-19 (EudraCT Number)

20120187

Details and patient eligibility

About

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.

Enrollment: 394 patients

Sex: Female

Ages: 55 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has provided informed consent prior to any study-specific activities/procedures
• Ambulatory postmenopausal women.
• Age 55 years or older
• Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar spine, total hip, or femoral neck.

Exclusion criteria

• Administration of osteoporosis treatments or bone active treatments within specific timeframes
• Vitamin D deficiency
• Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism; hypo/hyperthyroidism, unless stable and well-controlled)
• Contraindications to denosumab therapy (e.g., hypocalcemia)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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394 participants in 2 patient groups

Denosumab CP2

Active Comparator group

Description:

Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year.

Treatment:

Drug: Denosumab (CP2)

Denosumab CP4

Experimental group

Description:

Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.

Treatment:

Drug: Denosumab (CP4)