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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name STRUCTURE

NCTNCT01796301 (opens ClinicalTrials.gov in a new tab)Other id20080289Other id2012-002948-24
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
436 participants (actual)
Sponsor
Amgen · Industry
Design
Randomized · Open label (no masking)
Countries
11 countries

United States, Argentina, Belgium, Canada, Colombia, Czechia, Denmark, Hungary, Poland, Spain, United Kingdom

Start
31 Jan 2013
Primary completion
14 May 2015
Completion
14 May 2015
First posted
21 Feb 2013 (estimated)
Last update posted
29 Nov 2022
Conditions
Postmenopausal Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 3

    STRUCTURE

    NCT01796301

    31 Jan 2013 to 14 May 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • RomozosumabDrug
  • TeriparatideDrug

Arms2

  • Experimental

    Romosozumab

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

  • Active comparator

    Teriparatide

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD)

    Time frame · Baseline, month 6 and month 12

    Registry 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.

Secondary outcomes(14)

  1. Percent Change From Baseline in Total Hip BMD at Month 6

    Time frame · Baseline and month 6

    Registry description

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

  2. Percent Change From Baseline in Total Hip BMD at Month 12

    Time frame · Baseline and month 12

    Registry description

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

  3. Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6

    Time frame · Baseline and month 6

    Registry description

    Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.

  4. Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12

    Time frame · Baseline and month 12

    Registry description

    Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.

  5. Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6

    Time frame · Baseline and month 6

    Registry description

    Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.

  6. Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12

    Time frame · Baseline and month 12

    Registry description

    Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.

  7. Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6

    Time frame · Baseline and month 6

    Registry description

    Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.

  8. Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12

    Time frame · Baseline and month 12

    Registry description

    Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.

  9. Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6

    Time frame · Baseline and month 6

    Registry description

    Total hip integral BMC was measured using quantitative computed tomography (QCT).

  10. Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12

    Time frame · Baseline and month 12

    Registry description

    Total hip integral BMC was measured using quantitative computed tomography (QCT).

  11. Percent Change From Baseline in Femoral Neck BMD at Month 6

    Time frame · Baseline and month 6

    Registry description

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

  12. Percent Change From Baseline in Femoral Neck BMD at Month 12

    Time frame · Baseline and month 12

    Registry description

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

  13. Percent Change From Baseline in Lumbar Spine BMD at Month 6

    Time frame · Baseline and month 6

    Registry description

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

  14. Percent Change From Baseline in Lumbar Spine BMD at Month 12

    Time frame · Baseline and month 12

    Registry description

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, month 6 and month 12

Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD)

GroupValue (percent change)Spread
Teriparatide-0.60.2
Romosozumab2.60.2
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline and month 6

Percent Change From Baseline in Total Hip BMD at Month 6

GroupValue (percent change)Spread
Teriparatide-0.80.2
Romosozumab2.30.2
Secondary outcomeLeast squares mean· Baseline and month 12

Percent Change From Baseline in Total Hip BMD at Month 12

GroupValue (percent change)Spread
Teriparatide-0.50.2
Romosozumab2.90.2
Secondary outcomeLeast squares mean· Baseline and month 6

Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6

GroupValue (percent change)Spread
Teriparatide-2.70.2
Romosozumab0.70.2
Secondary outcomeLeast squares mean· Baseline and month 12

Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12

GroupValue (percent change)Spread
Teriparatide-3.60.3
Romosozumab1.10.3
Secondary outcomeLeast squares mean· Baseline and month 6

Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6

GroupValue (percent change)Spread
Teriparatide-0.80.2
Romosozumab2.30.2
Secondary outcomeLeast squares mean· Baseline and month 12

Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12

GroupValue (percent change)Spread
Teriparatide-0.20.2
Romosozumab3.40.2
Secondary outcomeLeast squares mean· Baseline and month 6

Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6

GroupValue (percent change)Spread
Teriparatide-1.00.2
Romosozumab2.10.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
TeriparatideParticipants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.–23 / 21476 / 214
RomosozumabParticipants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.–17 / 21879 / 218

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2017

7 results

Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial.

Langdahl et al. 2017Lancet (London, England)cited by 360

PMID 28755782DOI 10.1016/s0140-6736(17)31613-6PUB-28755782

Full text at the publisher7 results
Publisher pageSee results (7)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2020

Corrected

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.

Takada et al. 2020Journal of bone and mineral metabolismcited by 31

PMID 31707465DOI 10.1007/s00774-019-01057-1PUB-31707465

Full text at the publisher
Publisher pageRead the notice

Eligibility

Who could join, as posted.

Sex
Female
Age
from 55 Years up to 90 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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