DRUG
Abaloparatide
Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.
Status
Completed
Phase
Phase 3
Enrollment
228
Locations
34
Results
Posted
Publications
4
Study summary
A 12-month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.
The primary objective of this prospective controlled study is to evaluate the efficacy and the safety of abaloparatide 80 micrograms (mcg) per day administered subcutaneously (SC) compared to placebo in men with osteoporosis. Efficacy was primarily assessed by the change in bone mineral density (BMD) over 12 months.
Interventions
DRUG
Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.
DRUG
Abaloparatide-matched placebo.
Timeline
First posted
Apr 30, 2018
Study start
May 3, 2018
Primary completion
Aug 17, 2021
Study completion
Sep 8, 2021
Results posted
Apr 7, 2023
Registry updated
Apr 7, 2023
Outcomes
Percent Change From Baseline in Lumbar Spine BMD at Month 12
Time frame · Baseline, Month 12
Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Total Hip BMD at Month 12
Time frame · Baseline, Month 12
Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Femoral Neck BMD at Month 12
Time frame · Baseline, Month 12
Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Lumbar Spine BMD at Month 6
Time frame · Baseline, Month 6
Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health.
Percent Change in Total Hip BMD From Baseline at Month 6
Time frame · Baseline, Month 6
Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Femoral Neck BMD at Month 6
Time frame · Baseline, Month 6
Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12
Time frame · Baseline, Month 12
Ultra-distal radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Distal One-third Radius BMD at Month 12
Time frame · Baseline, Month 12
Distal one-third radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12
Time frame · Baseline, Month 12
Blood samples were taken to measure s-PINP, a bone formation marker. s-PINP concentrations reflect the rate of skeletal new bone formation. Increases in s-PINP indicate anabolic biologic response in the bone.
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12
Time frame · Baseline, Month 12
Blood samples were taken to measure s-CTX. Elevated levels of s-CTX indicate increased bone resorption (bone loss).
Number of Participants With New Clinical Fractures
Time frame · Baseline through Month 12
Radiological evaluations were performed to identify any new clinical fractures (occurring after the screening visit).
Eligibility
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.
Study locations
Italy · Poland · United States. Showing up to 24 locations stored in the fast local snapshot.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Marin Endocrine Care & Research, Inc.
Greenbrae, California, United States
Alta California Medical Group
Simi Valley, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Panorama Orthopedics & Spine Center
Golden, Colorado, United States
MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
Washington D.C., District of Columbia, United States
Indago Research & Health Center, Inc.
Hialeah, Florida, United States
Baptist Diabetes Associates, Pa
Miami, Florida, United States
Center For Advanced Research & Education
Gainesville, Georgia, United States
Meridian Clinical Research
Savannah, Georgia, United States
Northwestern University
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
New Mexico Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, United States
SUNY Upstate Medical University
Syracuse, New York, United States
PMG Research of Cary, LLC
Cary, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Centex Studies, Inc.
Houston, Texas, United States
Centex Studies, Inc
McAllen, Texas, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
University of Wisconsin Osteoporosis Clinical Research Program
Madison, Wisconsin, United States
Azienda ospedaliera universitaria Careggi
Florence, Tuscany, Italy
Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
Siena, Tuscany, Italy
Publications
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