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

CompletadoFase 3ClinicalTrials.gov

ID: NCT01796301RENIS: IS000427Tipo: INTERVENTIONALInicio: 31 de ene de 2013Fin estimado: 14 de may de 2015

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 55 YearsEdad máxima: 90 YearsSexo: FEMALE

Criterios de inclusión

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.

Criterios de exclusión

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

Intervenciones

drug

Romozosumab

Administered by subcutaneous injection once a month.

drug

Teriparatide

Administered by subcutaneous injection once a day.

Ubicaciones

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

Patrocinadores

PrincipalAmgen

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