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

Primary Purpose

Postmenopausal Osteoporosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Romozosumab
Teriparatide
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Postmenopausal Osteoporosis

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Romosozumab

Teriparatide

Arm Description

Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.

Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent Change From Baseline in Total Hip BMD at Month 6
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Percent Change From Baseline in Total Hip BMD at Month 12
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
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.
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.
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.
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.
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.
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.
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).
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).
Percent Change From Baseline in Femoral Neck BMD at Month 6
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Percent Change From Baseline in Femoral Neck BMD at Month 12
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Percent Change From Baseline in Lumbar Spine BMD at Month 6
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Percent Change From Baseline in Lumbar Spine BMD at Month 12
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

Full Information

First Posted
February 19, 2013
Last Updated
November 4, 2022
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01796301
Brief Title
An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
Acronym
STRUCTURE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2013 (Actual)
Primary Completion Date
May 14, 2015 (Actual)
Study Completion Date
May 14, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
Keywords
Postmenopausal Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
436 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Romosozumab
Arm Type
Experimental
Arm Description
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Arm Title
Teriparatide
Arm Type
Active Comparator
Arm Description
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
Intervention Type
Drug
Intervention Name(s)
Romozosumab
Other Intervention Name(s)
AMG 785
Intervention Description
Administered by subcutaneous injection once a month.
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Other Intervention Name(s)
Forteo, Forsteo
Intervention Description
Administered by subcutaneous injection once a day.
Primary Outcome Measure Information:
Title
Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD)
Description
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.
Time Frame
Baseline, month 6 and month 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Total Hip BMD at Month 6
Description
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Time Frame
Baseline and month 6
Title
Percent Change From Baseline in Total Hip BMD at Month 12
Description
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Time Frame
Baseline and month 12
Title
Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6
Description
Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.
Time Frame
Baseline and month 6
Title
Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12
Description
Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.
Time Frame
Baseline and month 12
Title
Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6
Description
Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.
Time Frame
Baseline and month 6
Title
Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12
Description
Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.
Time Frame
Baseline and month 12
Title
Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6
Description
Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.
Time Frame
Baseline and month 6
Title
Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12
Description
Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.
Time Frame
Baseline and month 12
Title
Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6
Description
Total hip integral BMC was measured using quantitative computed tomography (QCT).
Time Frame
Baseline and month 6
Title
Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12
Description
Total hip integral BMC was measured using quantitative computed tomography (QCT).
Time Frame
Baseline and month 12
Title
Percent Change From Baseline in Femoral Neck BMD at Month 6
Description
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Time Frame
Baseline and month 6
Title
Percent Change From Baseline in Femoral Neck BMD at Month 12
Description
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Time Frame
Baseline and month 12
Title
Percent Change From Baseline in Lumbar Spine BMD at Month 6
Description
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Time Frame
Baseline and month 6
Title
Percent Change From Baseline in Lumbar Spine BMD at Month 12
Description
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Time Frame
Baseline and month 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Research Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Research Site
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Research Site
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1128AAF
Country
Argentina
Facility Name
Research Site
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
X5000BNB
Country
Argentina
Facility Name
Research Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Liege 1
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3X8
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Research Site
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Research Site
City
Barranquilla
State/Province
Atlántico
ZIP/Postal Code
08001000
Country
Colombia
Facility Name
Research Site
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Research Site
City
Ostrava 1
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Research Site
City
Plzen
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
Research Site
City
Praha 11 - Chodov
ZIP/Postal Code
148 00
Country
Czechia
Facility Name
Research Site
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Research Site
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Research Site
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Research Site
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
Facility Name
Research Site
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Research Site
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Research Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Research Site
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1123
Country
Hungary
Facility Name
Research Site
City
Gdynia
ZIP/Postal Code
81-384
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
Research Site
City
Granada
State/Province
Andalucía
ZIP/Postal Code
18012
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08041
Country
Spain
Facility Name
Research Site
City
LHospitalet de Llobregat
State/Province
Cataluña
ZIP/Postal Code
08907
Country
Spain
Facility Name
Research Site
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Cardiff
ZIP/Postal Code
CF14 5GJ
Country
United Kingdom
Facility Name
Research Site
City
Chorley
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
Research Site
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Research Site
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Research Site
City
Reading
ZIP/Postal Code
RG2 0TG
Country
United Kingdom
Facility Name
Research Site
City
Sidcup
ZIP/Postal Code
DA14 6LT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28755782
Citation
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.
Results Reference
background
PubMed Identifier
31707465
Citation
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;:
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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