NCT00896532

Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density

A Randomised, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 785 in the Treatment of Postmenopausal Women With Low Bone Mineral Density

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 419 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objective was to determine the effect of treatment with romosozumab versus placebo at month 12 on the percent change from baseline in bone mineral density (BMD) at the lumbar spine in postmenopausal women with low bone density.

Detailed description

This study included a 24-month treatment phase followed by rerandomization to a 12-month extension phase with denosumab or placebo, followed by a 12-month retreatment phase with romosozumab, followed by a 24-month follow-on phase with zoledronic acid or no intervention. * 24-month Romosozumab Treatment Phase (months 1 to 24): Participants were randomized in a 1:1:1:1:1:1:1:1 ratio to receive 1 of 5 double-blind dosing regimens of romosozumab or placebo or open-label alendronate (ALN) or open-label teriparatide (TPTD) for the first 12 months of the study. At month 12, participants in the romosozumab and placebo groups continued their assigned treatment for an additional 12 months, participants in the TPTD group ended study participation, and participants in the ALN group transitioned to receive romosozumab 140 mg subcutaneously (SC) every month (QM) for an additional 12 months (months 12 to 24). * 12-month Denosumab Extension Phase (months 24 to 36): At the end of the 24-month romosozumab treatment phase, eligible participants were randomized 1:1 within their original treatment group to receive either denosumab or placebo every 6 months (Q6M) for 12 months. * 12-month Romosozumab Retreatment Phase (months 36 to 48): From months 36 to 48, participants initially randomized to romosozumab or placebo received romosozumab 210 mg SC QM. Participants who initially received ALN ended their participation at month 36 and were not retreated with romosozumab. * 24-month Follow-on Phase (months 48 to 72): At month 48, participants received 1 dose of zoledronic acid 5 mg intravenously or no intervention for an additional 24 months.

Conditions

• Low Bone Mineral Density
• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Placebo to Romosozumab	Administered by subcutaneous injection QM or Q3M.
DRUG	Alendronate	Administered orally once a week
DRUG	Teriparatide	Teriparatide 20 μg administered by subcutaneous injection once a day
DRUG	Romosozumab	Administered by subcutaneous injection
DRUG	Denosumab	Denosumab 60 mg administered by subcutaneous injection Q6M
DRUG	Placebo to Denosumab	Administered by subcutaneous injection Q6M
DRUG	Zoledronic acid	Zoledronic acid 5 mg administered intravenously

Timeline

• Start date: 2009-06-03
• Primary completion: 2011-02-21
• Completion: 2016-02-18
• First posted: 2009-05-11
• Last updated: 2022-09-22
• Results posted: 2018-12-14