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

Completed · Phase 3

Conditions studied: Postmenopausal Osteoporosis

In brief

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.

Key facts

Study ID

NCT01796301

Run by

Amgen

People needed

436

Starts

2013-01-31

Expected to finish

2015-05-14

Last updated by the study team

2022-11-29

Who can join

Age: 55 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Research Site — Aalborg, Denmark

Full record on ClinicalTrials.gov

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