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Sclerostin Inhibitor
An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women (STRUCTURE Trial)
Budapest, Hungary
Phase 3
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 6 and month 12
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial
Summary
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.
See full description
Eligible Conditions
- Osteoporosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 6 and month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 6 and month 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bone and Bones
Secondary study objectives
Hip structure
Hip structure
Hip structure
+11 moreSide effects data
From 2015 Phase 3 trial • 436 Patients • NCT0179630110%
Nasopharyngitis
10%
Hypercalcaemia
6%
Arthralgia
6%
Back pain
4%
Upper respiratory tract infection
4%
Headache
2%
Fall
2%
Musculoskeletal pain
2%
Pain in extremity
1%
Abdominal pain
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Teriparatide
Romosozumab
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RomosozumabExperimental Treatment1 Intervention
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Group II: TeriparatideActive Control1 Intervention
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Romosozumab
FDA approved
Find a Location
Closest Location:Research Site· Boston, MA
Who is running the clinical trial?
AmgenLead Sponsor
1,501 Previous Clinical Trials
1,424,306 Total Patients Enrolled
57 Trials studying Osteoporosis
560,170 Patients Enrolled for Osteoporosis
MDStudy DirectorAmgen
1,015 Previous Clinical Trials
946,687 Total Patients Enrolled
40 Trials studying Osteoporosis
554,393 Patients Enrolled for Osteoporosis