Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
Condition: Osteoporosis; Osteoporosis, Age-Related; Osteoporosis Localized to Spine; Age Related Osteoporosis; Osteoporosis Senile; Osteoporosis of Vertebrae
MeSH terms: Osteoporosis
Intervention: Abaloparatide; Placebo
Intervention description: Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.; Abaloparatide-matched placebo.
Intervention MeSH terms: Abaloparatide; Parathyroid Hormone-Related Protein
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized in a 2:1 treatment ratio (abaloparatide:placebo).
Masking: 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 participant.
Enrollment: 228.0
Sex: Male
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: BA058; abaloparatide; abaloparatide-SC; osteoporosis; male osteoporosis; TYMLOS®; fracture; bone loss

Summary:

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

Eligibility criteria:

        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.