Conditions: Postmenopausal Osteoporosis
Keywords: Postmenopausal Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 294
Healthy volunteers: no

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

Detailed 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.

Arms:
arm 1: Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous (SC) 1.17 mL injections of a 90 mg/mL solution, for 6 months. arm 2: Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months. arm 3: Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1.0 mL injections of a 70 mg/mL solution, for 6 months. arm 4: Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months.

Interventions: intervention 1: Romosozumab 90 mg/mL intervention 2: Placebo 90 mg/mL intervention 3: Romosozumab 70 mg/mL intervention 4: Placebo 70 mg/mL
Intervention descriptions: intervention 1: Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS). intervention 2: Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS. intervention 3: Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS. intervention 4: Placebo administered as 3 SC injections with the 1.0 mL glass PFS.

Protocol document: