Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density
Condition: Low Bone Mineral Density; Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Placebo to Romosozumab; Alendronate; Teriparatide; Romosozumab; Denosumab; Placebo to Denosumab; Zoledronic acid
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered by subcutaneous injection QM or Q3M.; Administered orally once a week; Teriparatide 20 μg administered by subcutaneous injection once a day; Administered by subcutaneous injection; Denosumab 60 mg administered by subcutaneous injection Q6M; Administered by subcutaneous injection Q6M; Zoledronic acid 5 mg administered intravenously
Other intervention name(s): Fosamax; Forsteo; AMG 785; EVENITY™; Prolia®; Aclasta
Intervention MeSH terms: Zoledronic Acid; Denosumab; Alendronate; Teriparatide; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment