Postmenopausal Osteoporosis Clinical Trial
— STRUCTUREOfficial 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
| Verified date | November 2022 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 436 |
| Est. completion date | May 14, 2015 |
| Est. primary completion date | May 14, 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 55 Years to 90 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Ciudad Autonoma de Buenos Aires | Buenos Aires |
| Argentina | Research Site | Ciudad Autonoma de Buenos Aires | Buenos Aires |
| Argentina | Research Site | Cordoba | Córdoba |
| Belgium | Research Site | Genk | |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | Leuven | |
| Belgium | Research Site | Liege 1 | |
| Canada | Research Site | Calgary | Alberta |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Vancouver | British Columbia |
| Colombia | Research Site | Barranquilla | Atlántico |
| Colombia | Research Site | Medellin | Antioquia |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Ostrava 1 | |
| Czechia | Research Site | Plzen | |
| Czechia | Research Site | Praha 11 - Chodov | |
| Czechia | Research Site | Uherske Hradiste | |
| Denmark | Research Site | Aalborg | |
| Denmark | Research Site | Aarhus C | |
| Denmark | Research Site | Ballerup | |
| Denmark | Research Site | Esbjerg | |
| Denmark | Research Site | Hillerød | |
| Denmark | Research Site | Hvidovre | |
| Denmark | Research Site | Odense | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Poland | Research Site | Gdynia | |
| Poland | Research Site | Katowice | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Wroclaw | |
| Spain | Research Site | Barcelona | Cataluña |
| Spain | Research Site | Granada | Andalucía |
| Spain | Research Site | LHospitalet de Llobregat | Cataluña |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Pozuelo de Alarcon | Madrid |
| United Kingdom | Research Site | Cardiff | |
| United Kingdom | Research Site | Chorley | |
| United Kingdom | Research Site | Liverpool | |
| United Kingdom | Research Site | Northwood | |
| United Kingdom | Research Site | Reading | |
| United Kingdom | Research Site | Sidcup | |
| 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 | Gainesville | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Argentina, Belgium, Canada, Colombia, Czechia, Denmark, Hungary, Poland, Spain, United Kingdom,
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. — View 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;: — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
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