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

  • Interventional
  • Recruiting
  • NCT03512262
Eligibility Details Visit Clinicaltrials.gov

A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis

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

The primary objective of this prospective controlled study is to evaluate the efficacy and the safety of abaloparatide-SC 80 mcg per day compared to placebo as assessed by change in bone mineral density over 12 months.

Gender
Male

Age Group
40 Years to 85 Years

Accepting Healthy Volunteers?
No

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.

At a Glance

National Government IDNCT03512262

IRB#IRB18-0257

Lead SponsorRadius Health, Inc.

Lead PhysicianTamara Vokes

Collaborator(s)N/A

EligibilityMale
40 Years to 85 Years
Recruiting