A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)

Description

The primary objective of this study is to determine the effect of treatment with AGA2118 versus placebo at Month 12 on lumbar spine bone mineral density (BMD) in postmenopausal women with low bone mass.

Conditions

Postmenopausal Osteoporosis

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Study Overview

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Study Details

Study overview

The primary objective of this study is to determine the effect of treatment with AGA2118 versus placebo at Month 12 on lumbar spine bone mineral density (BMD) in postmenopausal women with low bone mass.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Safety, Tolerability and Efficacy of AGA2118 in Postmenopausal Women With Low Bone Mineral Density

A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)

Condition
Postmenopausal Osteoporosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Tucson

Del Sol Research Management, LLC, Tucson, Arizona, United States, 85715

Gainesville

Center for Advanced Research & Education, Gainesville, Georgia, United States, 30501

Cumberland

Klein & Associates, M.D., P.A., Cumberland, Maryland, United States, 21502

Missoula

Montana Medical Research, Inc, Missoula, Montana, United States, 59808

Albuquerque

NM Clinical Research & Osteoporosis Center, Inc., Albuquerque, New Mexico, United States, 87160

Duncansville

Altoona Center for Clinical Research, Duncansville, Pennsylvania, United States, 16635

Burien

Puget Sound Osteoporosis Center, Burien, Washington, United States, 98166

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.

Ages Eligible for Study

55 Years to 80 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Angitia Biopharmaceuticals,

Ricardo Dent-Acosta, MD, STUDY_DIRECTOR, Angitia Incorporated Limited

Study Record Dates

2027-08