A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis

Amgen

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Placebo 70 mg/mL; Drug: Placebo 90 mg/mL; Drug: Romosozumab 70 mg/mL; Drug: Romosozumab 90 mg/mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02016716

2013-000434-35 (EudraCT Number)

20120156

Details and patient eligibility

About

The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.

Full description

Upon confirmation of eligibility, participants were randomized in a 22:5:22:5 ratio to the following treatment groups:

• Romosozumab 90 mg/mL
• Placebo 90 mg/mL
• Romosozumab 70 mg/mL
• Placebo 70 mg/mL

After completing a 6-month treatment period, participants entered a 3-month follow-up period with an end of study (EOS) at month 9.

For the analysis of efficacy endpoints, the 2 placebo groups were combined into a single placebo group. For safety analyses, the data for placebo were presented separately for each group.

Enrollment: 294 patients

Sex: Female

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Postmenopausal women with osteoporosis at high risk for fracture defined as

• BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND
• a history of fragility fracture or at least 2 other risk factors

Exclusion criteria

• BMD T score < -3.50 at the total hip or femoral neck.
• History of hip fracture.
• History of metabolic or bone disease (except osteoporosis).
• Use of agents affecting bone metabolism.
• Vitamin D insufficiency.
• History of solid organ or bone marrow transplants.
• Hyper- or hypocalcemia.
• Hyper- or hypothyroidism.
• Hyper- or hypoparathyroidism.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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294 participants in 4 patient groups, including a placebo group

Romosozumab 90 mg/mL

Experimental group

Description:

Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous (SC) 1.17 mL injections of a 90 mg/mL solution, for 6 months.

Treatment:

Drug: Romosozumab 90 mg/mL

Placebo 90 mg/mL

Experimental group

Description:

Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months.

Treatment:

Drug: Placebo 90 mg/mL

Romosozumab 70 mg/mL

Experimental group

Description:

Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1.0 mL injections of a 70 mg/mL solution, for 6 months.

Treatment:

Drug: Romosozumab 70 mg/mL

Placebo 70 mg/mL

Placebo Comparator group

Description:

Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months.

Treatment:

Drug: Placebo 70 mg/mL