Last updated on January 2019

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Osteoporosis of Vertebrae | Osteoporosis Localized to Spine | Osteoporosis
  • Age: Between 40 - 85 Years
  • Gender: Male

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.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.