Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
A 12 month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.
- Osteoporosis, Age-Related
- Osteoporosis Localized to Spine
- Age Related Osteoporosis
- Osteoporosis Senile
- Osteoporosis of Vertebrae
- Eligible Ages
- Between 40 Years and 85 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized patients will received a 2:1 ratio of abaloparatide:placebo injections.
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Treatment will be blinded to participants, investigators, outcome Assessor and care provider throughout the study except in a medical emergency where the identity of study medication is necessary to appropriately treat the patient.
|Abaloparatide is an active synthetic peptide of parathyroid hormone||
|Placebo with no peptide of parathyroid hormone||
- Radius Health, Inc.
Study ContactRadius Health, Inc.
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.