To study the effect and safety of drug product Romosozumab in Postmenopausal Women With Osteoporosis.

A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/10/003078

Enrollment

6600

Registered

2012-10-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M810- Age-related osteoporosis without current pathological fracture Health Condition 2: null- Postmenopausal Osteoporosis

Interventions

Intervention1: Experimental: Active Treatment sub-cutaneous AMG 785 injections for 12 months, followed by sub-cutaneous open-label denosumab injections for another 24 months: Drug: AMG 785 sub-cutan

Eligibility

Inclusion criteria

Inclusion criteria: Postmenopausal women osteoporosis, defined as low bone mineral density

Exclusion criteria

Exclusion criteria: Severe osteoporosis Use of agents affecting bone metabolism History of metabolic or bone disease (except osteoporosis) Vitamin D insufficiency (vitamin D repletion and rescreening is permitted) Current hyper- or hypocalcemia Current, uncontrolled hyper or hypothyroidism Current, uncontrolled hyper or hypoparathyroidism

Design outcomes

Primary

Measure	Time frame
Incidence of vertebral fractureTimepoint: [ Time Frame: 12 Months, 24 Months ] [ Designated as safety issue: No ]	—

Secondary

Measure	Time frame
Changes In Bone Mineral Density from Baseline to 12 MonthsTimepoint: [ Time Frame: 12 Months ] [ Designated as safety issue: No ] ;Changes In Bone Mineral Density from Baseline to 24 MonthsTimepoint: [ Time Frame: 24 Months ] [ Designated as safety issue: No ] ;Incidence of FractureTimepoint: [ Time Frame: 12 Months ] [ Designated as safety issue: No ]	—

Countries

Argentina, Australia, Belgium, Brazil, Canada, Colombia, Czech Republic, Denmark, Dominican Republic, Estonia, Germany, Hong Kong, Hungary, India, Japan, Latvia, Lithuania, Mexico, New Zealand, Poland, Romania, Spain, Switzerland, United Kingdom, United States of America

Contacts

Public ContactDr Veena Jaguste

Amgen N.V

abortels@amgen.com3227752792

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026