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

BA058-05-019

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

2018-05-03

2021-08-17

2021-09-08

Completed

Early phase I

228

Key Inclusion Criteria * Healthy ambulatory male from 40 to 85 years of age (inclusive) with primary osteoporosis or osteoporosis associated with hypogonadism. * The participant has a BMD T-score based on female or male reference range (depending on date of enrollment) as assessed by the central imaging vendor of ≤ -2.5 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (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. * Hypogonadal participants 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), parathyroid hormone, serum phosphorus and alkaline phosphatase, and thyroid stimulating hormone values. Key Exclusion Criteria * Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal BMD, 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 on female or male reference range (depending on date of enrollment). * Unevaluable hip BMD or participants 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 (for example, Paget's disease) other than osteoporosis. * participant 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 participant. * History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized in a 2:1 treatment ratio (abaloparatide:placebo).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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 participant.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 228, 'type': 'ACTUAL'}}

2023-04-07