Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)

Description

A 12 month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.

Study Start Date

March, 30 2018

Estimated Completion Date

December 2019

Interventions

  • Drug: Abaloparatide
  • Drug: Placebo

Study ID

Radius Health, Inc. -- BA058-05-019

Status

Unknown

Trial ID

NCT03512262

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

225

Sponsor

Radius Health, Inc.

INCLUSION CRITERIA
  • Healthy ambulatory male from 40 to 85 years of age (inclusive) with primary osteoporosis or osteoporosis associated with hypogonadism.
  • The patient has a BMD T-score (based on the female reference range as assessed by the central imaging vendor) of ? -2.5 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by DXA or ?-1.5 and with radiologic evidence of vertebral fracture or a documented history of low-trauma nonvertebral fracture sustained in the past 5 years. Men older than 65 years may be enrolled if they have a BMD T-score ? -2.0 even if they do not meet the fracture criteria.
  • Normal medical history, physical examination, including vital signs, and body mass index (BMI).
  • Hypogonadal patients whose doses of androgens have been stable for at least twelve months before randomization are eligible and may continue therapy during the study.
  • Laboratory tests within the normal range including serum calcium (albumin-corrected), PTH, serum phosphorus and alkaline phosphatase, and thyroid stimulating hormone (TSH) values. EXCLUSION CRITERIA
  • Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal bone mineral density, defined as having at least 2 radiologically evaluable vertebrae within L1-L4.
  • A BMD T-score of ?-3.5 at the total hip, femoral neck, or lumbar spine based upon the female reference range.
  • Unevaluable hip BMD or patients who have undergone bilateral hip replacement.
  • Fragility fracture within the prior twelve months.
  • History of severe vertebral fracture or >2 moderate vertebral fractures.
  • History of bone disorders (e.g., Paget's disease) other than osteoporosis.
  • Patients with clinical signs of hypogonadism present at screening who plan to initiate testosterone replacement.
  • History of prior external beam or implant radiation therapy involving the skeleton other than radioiodine.
  • History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances to a degree that would interfere with the interpretation of study data or compromise the safety of the patient.
  • History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo
  • or hyperparathyroidism or malabsorptive syndromes within the past year.
  • Gender

    Male

    Ages

    40 Years to 85 Years

    Accepts Healthy Volunteers

    No

    Study Locations and Contact Information (1)

    Study Location Distance Name Phone Email
    Radius Health Inc - Waltham, Massachusetts 132.4 miles Study Director None None

    ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.