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



Status:Recruiting
Conditions:Osteoporosis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:40 - 85
Updated:1/17/2019
Start Date:March 30, 2018
End Date:December 2019
Contact:Radius Health, Inc.
Email:info@radiuspharm.com
Phone:617-551-4002

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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.

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.
We found this trial at
23
sites
Savannah, Georgia 31406
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Albuquerque, NM
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Cary, North Carolina 27518
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303 East Superior Street
Chicago, Illinois 60611
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Columbus, OH
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Duncansville, Pennsylvania 16635
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Gainesville, Georgia 30501
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660 Golden Ridge Road
Golden, Colorado 80401
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Greenbrae, California 94904
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Hialeah, Florida 33012
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Houston, Texas 77062
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McAllen, Texas 78504
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Miami, Florida 33156
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Richmond, Virginia 23249
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Simi Valley, California 93065
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750 East Adams Street
Syracuse, New York 13210
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Walnut creek, California 94598
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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