Current partner codePEPTIDESDE
NCT03512262·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

228

Locations

34

Results

Posted

Publications

4

Study summary

What the protocol is testing.

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

Full detailed description

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

Treatment arms and agents.

DRUG

Abaloparatide

Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.

DRUG

Placebo

Abaloparatide-matched placebo.

Timeline

From registration to results.

  1. First posted

    Apr 30, 2018

  2. Study start

    May 3, 2018

  3. Primary completion

    Aug 17, 2021

  4. Study completion

    Sep 8, 2021

  5. Results posted

    Apr 7, 2023

  6. Registry updated

    Apr 7, 2023

Outcomes

What the study measures.

Primary 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.

Secondary outcomes

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

Who can take part.

Minimum age
40 Years
Maximum age
85 Years
Sex
MALE
Healthy volunteers
No

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

34 registered sites.

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

Related trials

More studies on Abaloparatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.