An Open-label Study to Evaluate the Effect of Treatment With AMG 785 or Teriparatide in Postmenopausal Women (STRUCTURE)

Condition(s) targeted: Postmenopausal Osteoporosis

Intervention: AMG 785 (Drug); Teriparatide (TPTD) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

This is a multi-center, randomized, open-label, TPTD-controlled study in postmenopausal women with osteoporosis at high risk for fracture.

Official title: An Open-label, Randomized, Teriparatide-controlled Study to Evaluate the Effect of Treatment With AMG 785 in Postmenopausal Women With Osteoporosis Previously Treated With Bisphosphonate Therapy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary endpoint is the percent change from baseline in DXA BMD at the total hip through Month 12.

Secondary outcome:

Percent change from baseline in BMD by DXA at the total hip at Month 6, and M12.

Percent change from baseline in cortical BMD by QCT at the total hip at Month 6 and M 12,

Percent change from baseline in integral BMD by QCT at the total hip at Month 6 and M 12

Percent change from baseline in estimated strength by FEA at the total hip at Month 6 and M 12

Detailed description: This is a multi-center, randomized, open-label, TPTD-controlled study in postmenopausal women with osteoporosis at high risk for fracture.

Minimum age: 55 Years. Maximum age: 90 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Postmenopausal women, aged ≥ 60 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, TPTD or any PTH analogs, Systemic oral or transdermal estrogen, 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

Research Site, Genk 3600, Belgium

Research Site, Gent 9000, Belgium

Research Site, Leuven 3000, Belgium

Research Site, Liege 1 4000, Belgium

Research Site, Quebec G1V 3M7, Canada

Research Site, Brno 602 00, Czech Republic

Research Site, Ostrava 1 702 00, Czech Republic

Research Site, Plzen 305 99, Czech Republic

Research Site, Praha 11 - Chodov 148 00, Czech Republic

Research Site, Uherske Hradiste 686 01, Czech Republic

Research Site, Aalborg 9000, Denmark

Research Site, Aarhus C 8000, Denmark

Research Site, Ballerup 2750, Denmark

Research Site, Esbjerg 6700, Denmark

Research Site, Hillerød 3400, Denmark

Research Site, Hvidovre 2650, Denmark

Research Site, Odense 5000, Denmark

Research Site, Budapest 1036, Hungary

Research Site, Budapest 1083, Hungary

Research Site, Budapest 1123, Hungary

Research Site, Gdynia 81-384, Poland

Research Site, Katowice 40-040, Poland

Research Site, Warszawa 01-192, Poland

Research Site, Wroclaw 50-088, Poland

Research Site, Madrid 28041, Spain

Research Site, Madrid 28046, Spain

Research Site, Cardiff CF14 5GJ, United Kingdom

Research Site, Chorley PR7 7NA, United Kingdom

Research Site, Liverpool L22 0LG, United Kingdom

Research Site, Northwood HA6 2RN, United Kingdom

Research Site, Reading RG2 0TG, United Kingdom

Research Site, Sidcup DA14 6LT, United Kingdom

Research Site, Calgary, Alberta T2N 4Z6, Canada

Research Site, Granada, Andalucía 18012, Spain

Research Site, Medellin, Antioquia, Colombia

Research Site, Barranquilla, Atlántico 08001000, Colombia

Research Site, Vancouver, British Columbia V6H 3X8, Canada

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

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

Research Site, Barcelona, Cataluña 08041, Spain

Research Site, LHospitalet de Llobregat, Cataluña 08907, Spain

Research Site, Cordoba, Córdoba X5000BNB, Argentina

Research Site, Gainesville, Georgia 30501, United States

Research Site, Pozuelo de Alarcon, Madrid 28223, Spain

Research Site, Bethesda, Maryland 20817, United States

Research Site, Boston, Massachusetts 02114, United States

Research Site, Boston, Massachusetts 02131, United States

Research Site, Detroit, Michigan 48236, United States

Research Site, Toronto, Ontario M5C 2T2, Canada

Research Site, Toronto, Ontario M5G 2C4, Canada

AmgenTrials clinical trials website

Starting date: January 2013
Last updated: July 13, 2015