Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis (ARCH)

Amgen

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Women With Osteoporosis

Treatments: Drug: Placebo to Romosozumab; Drug: Alendronate; Biological: Romosozumab; Drug: Placebo to Alendronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01631214

20110142

2011-003142-41 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.

Full description

In this trial, women were randomly assigned in a 1:1 ratio to receive monthly subcutaneous romosozumab or weekly oral alendronate for 12 months. Randomization was stratified according to age (<75 vs. ≥75 years). After completion of the double-blind treatment period, all the participants were to receive open-label weekly oral alendronate until the end of the trial, with blinding to the initial treatment assignment maintained.

The primary analysis was performed when clinical fracture events had been confirmed in at least 330 participants and all the participants had completed the month 24 visit. The study was to continue in an event-driven manner until at least 440 participants experienced a nonvertebral fracture or if the superiority of romosozumab was proven for nonvertebral fractures at the primary analysis.

Enrollment: 4,093 patients

Sex: Female

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Postmenopausal women who meet at least one of the following bone mineral density (BMD) and fracture criteria:

• BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER:

  • at least 1 moderate (semiquantitative grade [SQ]2) or severe (SQ3) vertebral fracture OR
  • at least 2 mild (SQ1) vertebral fractures OR

• BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER:

  • at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR
  • a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization.

Exclusion criteria

• 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
• Possible signs of intolerance to alendronate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4,093 participants in 2 patient groups

Alendronate/Alendronate

Active Comparator group

Description:

Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.

Treatment:

Drug: Alendronate

Drug: Placebo to Romosozumab

Romosozumab/Alendronate

Experimental group

Description:

Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Treatment:

Drug: Placebo to Alendronate

Biological: Romosozumab

Drug: Alendronate