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

Postmenopausal Osteoporosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796301
• Other study ID #: 20080289
• Secondary ID: 2012-002948-24
• Status: Completed
• Phase: Phase 3
• Start date: January 31, 2013
• Est. completion date: May 14, 2015

Study information

• Verified date: November 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• Romozosumab
Administered by subcutaneous injection once a month.
• Teriparatide
Administered by subcutaneous injection once a day.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

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

References & Publications (2)

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

Outcome

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

External Links

•   AmgenTrials clinical trials website