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

• Status: Completed
• Trial end date: 2021-09-08
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radius Health, Inc.
• Treatments: Abaloparatide; Parathyroid Hormone-Related Protein

Criteria

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.