Completed
STRUCTUREAn Open-label, Randomized, Teriparatide-controlled Study to Evaluate the Effect of Treatment With Romosozumab in Postmenopausal Women With Osteoporosis Previously Treated With Bisphosphonate Therapy
What is being tested
Romozosumab
+ Teriparatide
Drug
Who is being recruted
Bone Diseases+4
+ Bone Diseases, Metabolic
+ Metabolic Diseases
From 55 to 90 Years
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: January 2013
Summary
Principal SponsorAmgen
Last updated: November 29, 2022
Sourced from a government-validated database.Claim as a partner
Study start date: January 31, 2013
Actual date on which the first participant was enrolled.The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.
Principal SponsorAmgen
Last updated: November 29, 2022
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
436 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.From 55 to 90 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Bone DiseasesBone Diseases, MetabolicMetabolic DiseasesMusculoskeletal DiseasesNutritional and Metabolic DiseasesOsteoporosisOsteoporosis, Postmenopausal
Criteria
4 inclusion criteria required to participate
BMD T-score <= -2.50 at the lumbar spine, total hip or femoral neck
History of nonvertebral fracture after age 50, or vertebral fracture
Postmenopausal women, aged >= 55 to <= 90
Received oral bisphosphonate therapy for at least 3 years immediately prior to screening
5 exclusion criteria prevent from participating
Current hyper- or hypocalcemia
Current, uncontrolled hyper- or hypothyroidism
History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of study results, such as sclerosteosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
Use of other agents affecting bone metabolism including Strontium ranelate, fluoride (for osteoporosis), odanacatib (MK-0822) or any other cathepsin K inhibitor, IV bisphosphonates, denosumab, teriparatide (TPTD) or any parathyroid hormone (PTH) analogs, Systemic oral or transdermal estrogen, selective estrogen receptor modulators (SERMs), activated vitamin D3, vitamin K2, calcitonin, tibolone, cinacalcet, systemic glucocorticosteroids
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalParticipants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Group II
Active ComparatorParticipants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 50 locations
Research Site
Bethesda, United StatesResearch Site
Boston, United StatesResearch Site
Boston, United StatesCompleted50 Study Centers