A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)
350 patients around the world
Available in Colombia, United States
This Phase 2 dose-finding study will evaluate the safety, tolerability, and efficacy of
AGA2118 at a range of dosing regimens in postmenopausal women with low BMD at the lumbar
spine, total hip, or femoral neck and no prior history of fragility fractures.
This study includes a 12 month blinded treatment phase where participants will be
randomized 1:1:1:1:1:1:1 to receive double-blind dosing regimens of AGA2118 or placebo.
At Month 12, participants who have completed the double-blind portion of the study will
continue on to a 12 month open-label period where they will be re-randomized based on
their prior dosing regimen to either continue their current dosing regimen, receive a new
dosing regimen, or discontinue treatment and be actively surveilled throughout Months 12
to 24.
Angitia Biopharmaceuticals
4Research sites
350Patients around the world
This study is for people with
Metabolic Bone Disease
Postmenopausal osteoporosis
Requirements for the patient
To 80 Years
Female
Medical requirements
Healthy, ambulatory, postmenopausal women age ≥ 55 to ≤ 80.
BMD T-score of ≤ -2.5 to > -3.5 at the lumbar spine, total hip, or femoral neck.
History of vertebral fracture, or fragility fracture of the wrist, humerus, proximal femur, or pelvis.
Vitamin D deficiency.
Known intolerance to calcium or vitamin D supplements.
Untreated hyper- or hypothyroidism.
Current hyper- or hypoparathyroidism.
Elevated transaminases.
Significantly impaired renal function.
Current hypo- or hypercalcemia.
Positive for HIV, hepatitis C virus, or hepatitis B surface antigen.
Malignancy within the last 5 years.
Diagnosis of a familial cancer syndrome or known genetic mutation that increases risk of cancer.
Myocardial infarction or stroke within the past 12 months.
Use of agents affecting bone metabolism.
Sites
Centro Integral de Reumatología del Caribe Circaribe SAS
Cl. 71 #41 - 46, Nte. Centro Histórico, Barranquilla, Atlántico
Centro de Investigación Médico Asistencial S.A.S. - CIMEDICAL S.A.S.
Cra 49c N 82 - 120 - Barranquilla
Uniendo Centro de Investigación - Solano y Terront Servicios Médicos Ltda.
Carrera 16 # 80-33, Bogotá
CIREEM SAS (Centro de Investigación en Reumatología y Especialidades Médicas) - Bogotá