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
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 | |
|---|---|---|---|---|
| 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.