An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women (STRUCTURE)

An Open-label, Randomized, Teriparatide-controlled Study to Evaluate the Effect of Treatment With Romosozumab in Postmenopausal Women With Osteoporosis Previously Treated With Bisphosphonate Therapy

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.

Study Overview

• Status: Completed
• Conditions: Postmenopausal Osteoporosis
• Intervention / Treatment: Drug: Romozosumab; Drug: Teriparatide

• Study Type: Interventional
• Enrollment (Actual): 436
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1012AAR
      • Research Site
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1128AAF
      • Research Site
  • Córdoba
    • Cordoba, Córdoba, Argentina, X5000BNB
      • Research Site
• Belgium
  • Genk, Belgium, 3600
    • Research Site
  • Gent, Belgium, 9000
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
  • Liege 1, Belgium, 4000
    • Research Site
• Canada
  • Quebec, Canada, G1V 3M7
    • Research Site
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Research Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3X8
      • Research Site
  • Ontario
    • Toronto, Ontario, Canada, M5C 2T2
      • Research Site
    • Toronto, Ontario, Canada, M5G 2C4
      • Research Site
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Research Site
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 08001000
      • Research Site
• Czechia
  • Brno, Czechia, 602 00
    • Research Site
  • Ostrava 1, Czechia, 702 00
    • Research Site
  • Plzen, Czechia, 305 99
    • Research Site
  • Praha 11 - Chodov, Czechia, 148 00
    • Research Site
  • Uherske Hradiste, Czechia, 686 01
    • Research Site
• Denmark
  • Aalborg, Denmark, 9000
    • Research Site
  • Aarhus C, Denmark, 8000
    • Research Site
  • Ballerup, Denmark, 2750
    • Research Site
  • Esbjerg, Denmark, 6700
    • Research Site
  • Hillerød, Denmark, 3400
    • Research Site
  • Hvidovre, Denmark, 2650
    • Research Site
  • Odense, Denmark, 5000
    • Research Site
• Hungary
  • Budapest, Hungary, 1083
    • Research Site
  • Budapest, Hungary, 1036
    • Research Site
  • Budapest, Hungary, 1123
    • Research Site
• Poland
  • Gdynia, Poland, 81-384
    • Research Site
  • Katowice, Poland, 40-040
    • Research Site
  • Warszawa, Poland, 01-192
    • Research Site
  • Wroclaw, Poland, 50-088
    • Research Site
• Spain
  • Madrid, Spain, 28046
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • Andalucía
    • Granada, Andalucía, Spain, 18012
      • Research Site
  • Cataluña
    • Barcelona, Cataluña, Spain, 08041
      • Research Site
    • LHospitalet de Llobregat, Cataluña, Spain, 08907
      • Research Site
  • Madrid
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Research Site
• United Kingdom
  • Cardiff, United Kingdom, CF14 5GJ
    • Research Site
  • Chorley, United Kingdom, PR7 7NA
    • Research Site
  • Liverpool, United Kingdom, L22 0LG
    • Research Site
  • Northwood, United Kingdom, HA6 2RN
    • Research Site
  • Reading, United Kingdom, RG2 0TG
    • Research Site
  • Sidcup, United Kingdom, DA14 6LT
    • Research Site
• United States
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Research Site
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Research Site
    • Boston, Massachusetts, United States, 02131
      • Research Site
  • Michigan
    • Detroit, Michigan, United States, 48236
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Postmenopausal women, aged ≥ 55 to ≤ 90.
• Received oral bisphosphonate therapy for at least 3 years immediately prior to screening
• BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck
• History of nonvertebral fracture after age 50, or vertebral fracture.

Exclusion Criteria:

• 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:
• 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.
• Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 20 ng/mL, as determined by the central laboratory.
• Current hyper- or hypocalcemia
• Current, uncontrolled hyper- or hypothyroidism

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Romosozumab; Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.	Drug: Romozosumab; Administered by subcutaneous injection once a month.; Other Names: AMG 785
Active Comparator: Teriparatide; Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.	Drug: Teriparatide; Administered by subcutaneous injection once a day.; Other Names: Forteo; Forsteo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD)	Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12.	Baseline, month 6 and month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Total Hip BMD at Month 6	Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).	Baseline and month 6
Percent Change From Baseline in Total Hip BMD at Month 12	Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).	Baseline and month 12
Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6	Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.	Baseline and month 6
Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12	Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.	Baseline and month 12
Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6	Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.	Baseline and month 6
Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12	Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.	Baseline and month 12
Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6	Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.	Baseline and month 6
Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12	Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.	Baseline and month 12
Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6	Total hip integral BMC was measured using quantitative computed tomography (QCT).	Baseline and month 6
Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12	Total hip integral BMC was measured using quantitative computed tomography (QCT).	Baseline and month 12
Percent Change From Baseline in Femoral Neck BMD at Month 6	Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).	Baseline and month 6
Percent Change From Baseline in Femoral Neck BMD at Month 12	Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).	Baseline and month 12
Percent Change From Baseline in Lumbar Spine BMD at Month 6	Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).	Baseline and month 6
Percent Change From Baseline in Lumbar Spine BMD at Month 12	Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).	Baseline and month 12

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• Takada J, Dinavahi R, Miyauchi A, Hamaya E, Hirama T, Libanati C, Nakamura Y, Milmont CE, Grauer A. Relationship between P1NP, a biochemical marker of bone turnover, and bone mineral density in patients transitioned from alendronate to romosozumab or teriparatide: a post hoc analysis of the STRUCTURE trial. J Bone Miner Metab. 2020 May;38(3):310-315. doi: 10.1007/s00774-019-01057-1. Epub 2019 Nov 9. Erratum In: J Bone Miner Metab. 2020 Mar 20;:
• Langdahl BL, Libanati C, Crittenden DB, Bolognese MA, Brown JP, Daizadeh NS, Dokoupilova E, Engelke K, Finkelstein JS, Genant HK, Goemaere S, Hyldstrup L, Jodar-Gimeno E, Keaveny TM, Kendler D, Lakatos P, Maddox J, Malouf J, Massari FE, Molina JF, Ulla MR, Grauer A. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. Lancet. 2017 Sep 30;390(10102):1585-1594. doi: 10.1016/S0140-6736(17)31613-6. Epub 2017 Jul 26.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2013
• Primary Completion (Actual): May 14, 2015
• Study Completion (Actual): May 14, 2015

Study Registration Dates

• First Submitted: February 19, 2013
• First Submitted That Met QC Criteria: February 20, 2013
• First Posted (Estimate): February 21, 2013

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Postmenopausal Osteoporosis
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Teriparatide
• Other Study ID Numbers: 20080289; 2012-002948-24 (EudraCT Number)