DRUG
Romozosumab
Administered by subcutaneous injection once a month.
An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
Status
Completed
Phase
Phase 3
Enrollment
436
Locations
50
Results
Posted
Publications
2
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DRUG
Teriparatide
Administered by subcutaneous injection once a day.
Timeline
From registration to results.
First posted
Feb 21, 2013
Study start
Jan 31, 2013
Primary completion
May 14, 2015
Study completion
May 14, 2015
Results posted
Nov 8, 2018
Registry updated
Nov 29, 2022
Outcomes
What the study measures.
Primary outcomes
Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD)
Time frame · Baseline, month 6 and month 12
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
Percent Change From Baseline in Total Hip BMD at Month 6
Time frame · Baseline and 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
Time frame · Baseline and 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
Time frame · Baseline and 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
Time frame · Baseline and 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
Time frame · Baseline and 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
Time frame · Baseline and 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
Time frame · Baseline and 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
Time frame · Baseline and 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
Time frame · Baseline and 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
Time frame · Baseline and month 12
Total hip integral BMC was measured using quantitative computed tomography (QCT).
Eligibility
Who can take part.
- Minimum age
- 55 Years
- Maximum age
- 90 Years
- Sex
- FEMALE
- Healthy volunteers
- No
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 locations
50 registered sites.
Argentina · Belgium · Canada · Colombia · Czechia · Denmark · Hungary · Poland · Spain · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Research Site
Gainesville, Georgia, United States
Research Site
Bethesda, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
Detroit, Michigan, United States
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Research Site
Córdoba, Córdoba Province, Argentina
Research Site
Genk, Belgium
Research Site
Ghent, Belgium
Research Site
Leuven, Belgium
Research Site
Liège, Belgium
Research Site
Calgary, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Québec, Quebec, Canada
Research Site
Medellín, Antioquia, Colombia
Research Site
Barranquilla, Atlántico, Colombia
Research Site
Brno, Czechia
Research Site
Ostrava, Czechia
Research Site
Pilsen, Czechia
Research Site
Praha 11 - Chodov, Czechia
Research Site
Uherské Hradiště, Czechia
Publications
Results and literature.
PMID 28755782 ↗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.PMID 31707465 ↗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.
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