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

NCT01796301 | Completed Phase 3 Results

• 2 other identifiers: 200802892012-002948-24
• Study Type: interventional
• Target: 436
• Locations: 11 countries
• Sites: 50

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.

Conditions

Postmenopausal Osteoporosis

Keywords

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Percent Change From Baseline in Total Hip BMD at Month 6

  Baseline and month 6

• Percent Change From Baseline in Total Hip BMD at Month 12

  Baseline and month 12

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

  Baseline and month 6

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

  Baseline and month 12

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

  Baseline and month 6

Study Arms (2)

Romosozumab

EXPERIMENTAL

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

Drug: Romozosumab

Teriparatide

ACTIVE COMPARATOR

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

Drug: Teriparatide

Interventions

Romozosumab DRUG

Administered by subcutaneous injection once a month.

Also known as: AMG 785

Romosozumab

Teriparatide DRUG

Administered by subcutaneous injection once a day.

Also known as: Forteo, Forsteo

Teriparatide

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (50)

Research Site

Gainesville, Georgia, 30501, United States

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Bethesda, Maryland, 20817, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02131, United States

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Detroit, Michigan, 48236, United States

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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1012AAR, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF, Argentina

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Córdoba, Córdoba Province, X5000BNB, Argentina

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Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Calgary, Alberta, T2N 4Z6, Canada

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Vancouver, British Columbia, V6H 3X8, Canada

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Toronto, Ontario, M5C 2T2, Canada

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Toronto, Ontario, M5G 2C4, Canada

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Québec, Quebec, G1V 3M7, Canada

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Medellín, Antioquia, Colombia

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Barranquilla, Atlántico, 08001000, Colombia

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Brno, 602 00, Czechia

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Ostrava, 702 00, Czechia

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Pilsen, 305 99, Czechia

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Praha 11 - Chodov, 148 00, Czechia

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Uherské Hradiště, 686 01, Czechia

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Aalborg, 9000, Denmark

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Aarhus C, 8000, Denmark

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Ballerup Municipality, 2750, Denmark

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Esbjerg, 6700, Denmark

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Hillerød, 3400, Denmark

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Hvidovre, 2650, Denmark

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Odense, 5000, Denmark

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Budapest, 1036, Hungary

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Budapest, 1083, Hungary

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Budapest, 1123, Hungary

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Gdynia, 81-384, Poland

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Katowice, 40-040, Poland

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Warsaw, 01-192, Poland

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Wroclaw, 50-088, Poland

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Granada, Andalusia, 18012, Spain

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Barcelona, Catalonia, 08041, Spain

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LHospitalet de Llobregat, Catalonia, 08907, Spain

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Pozuelo de Alarcón, Madrid, 28223, Spain

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Madrid, 28041, Spain

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Madrid, 28046, Spain

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Cardiff, CF14 5GJ, United Kingdom

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Chorley, PR7 7NA, United Kingdom

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Liverpool, L22 0LG, United Kingdom

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Northwood, HA6 2RN, United Kingdom

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Reading, RG2 0TG, United Kingdom

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Sidcup, DA14 6LT, United Kingdom

Location

Related 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.

  PMID: 28755782 BACKGROUND

• 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.

  PMID: 31707465 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

romosozumab; Teriparatide

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: February 21, 2013
• Study Start: January 31, 2013
• Primary Completion: May 14, 2015
• Study Completion: May 14, 2015
• Last Updated: November 29, 2022
• Results First Posted: November 8, 2018

Record last verified: 2022-11

Locations

GB (6); CZ (5); ES (6); PL (4); US (5); CA (5); DK (7); HU (3); AR (3); CO (2); BE (4)