Skip to content

Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT03512262 (opens ClinicalTrials.gov in a new tab)Other idBA058-05-019Other idATOM
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
228 participants (actual)
Sponsor
Radius Health, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
3 countries

United States, Italy, Poland

Start
3 May 2018
Primary completion
17 Aug 2021
Completion
8 Sept 2021
First posted
30 Apr 2018
Last update posted
7 Apr 2023
Conditions
Osteoporosis · Osteoporosis, Age-Related · Osteoporosis Localized to Spine · Age Related Osteoporosis · Osteoporosis Senile · Osteoporosis of Vertebrae

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20182019202020212022
  1. Ph 3

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

    NCT03512262

    3 May 2018 to 8 Sept 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • AbaloparatideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Abaloparatide

    Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.

  • Placebo comparator

    Placebo

    Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change From Baseline in Lumbar Spine BMD at Month 12

    Time frame · Baseline, Month 12

    Registry description

    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(14)

  1. Percent Change From Baseline in Total Hip BMD at Month 12

    Time frame · Baseline, Month 12

    Registry description

    Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.

  2. Percent Change From Baseline in Femoral Neck BMD at Month 12

    Time frame · Baseline, Month 12

    Registry description

    Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.

  3. Percent Change From Baseline in Lumbar Spine BMD at Month 6

    Time frame · Baseline, Month 6

    Registry description

    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.

  4. Percent Change in Total Hip BMD From Baseline at Month 6

    Time frame · Baseline, Month 6

    Registry description

    Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.

  5. Percent Change From Baseline in Femoral Neck BMD at Month 6

    Time frame · Baseline, Month 6

    Registry description

    Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.

  6. Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12

    Time frame · Baseline, Month 12

    Registry description

    Ultra-distal radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health.

  7. Percent Change From Baseline in Distal One-third Radius BMD at Month 12

    Time frame · Baseline, Month 12

    Registry description

    Distal one-third radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health.

  8. Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12

    Time frame · Baseline, Month 12

    Registry description

    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.

  9. 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

    Registry description

    Blood samples were taken to measure s-CTX. Elevated levels of s-CTX indicate increased bone resorption (bone loss).

  10. Number of Participants With New Clinical Fractures

    Time frame · Baseline through Month 12

    Registry description

    Radiological evaluations were performed to identify any new clinical fractures (occurring after the screening visit).

  11. Percent of Participants With Change in Disease Status

    Time frame · Baseline through Month 12

    Registry description

    The percentage of participants converting from the categories of osteoporosis to osteopenia or from osteopenia to normal at End of Treatment (Month 12) was assessed. Osteoporosis was defined as lumbar spine or total hip BMD T-score ≤ -2.5. Osteopenia was defined as one of the following: * Lumbar spine \> -2.5 and total hip BMD T-score \> -2.5 and \< -1.0 * Lumbar spine \> -2.5 and \< -1.0 and total hip BMD T-score \> -2.5 * Normal was defined as lumbar spine and total hip BMD T-score ≥ -1.0.

  12. Percent of Participants Experiencing BMD Gains From Baseline of > 0%, > 3%, and > 6% at the Lumbar Spine, Femoral Neck, and Total Hip

    Time frame · Month 12

    Registry description

    Lumbar spine, femoral neck, and total hip BMD were assessed by DXA scans evaluated by a central imaging laboratory.

  13. Percent Change From Baseline in Total Hip Volumetric BMD as Measured by Quantitative Computed Tomography (QCT) at Month 12

    Time frame · Baseline, Month 12

    Registry description

    QCT scans were evaluated by a central imaging laboratory.

  14. Percent Change From Baseline in Femoral Neck Volumetric BMD as Measured by QCT at Month 12

    Time frame · Baseline, Month 12

    Registry description

    QCT scans were evaluated by a central imaging laboratory.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Month 12

Percent Change From Baseline in Lumbar Spine BMD at Month 12

GroupValue (percent change)Spread
Abaloparatide8.48200.5353
Placebo1.16540.7235
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, Month 12

Percent Change From Baseline in Total Hip BMD at Month 12

GroupValue (percent change)Spread
Abaloparatide2.13510.2711
Placebo0.01430.3543
Secondary outcomeLeast squares mean· Baseline, Month 12

Percent Change From Baseline in Femoral Neck BMD at Month 12

GroupValue (percent change)Spread
Abaloparatide2.97660.3448
Placebo0.15450.4527
Secondary outcomeLeast squares mean· Baseline, Month 6

Percent Change From Baseline in Lumbar Spine BMD at Month 6

GroupValue (percent change)Spread
Abaloparatide5.54360.4127
Placebo0.64180.5472
Secondary outcomeLeast squares mean· Baseline, Month 6

Percent Change in Total Hip BMD From Baseline at Month 6

GroupValue (percent change)Spread
Abaloparatide1.38880.2142
Placebo0.02670.2790
Secondary outcomeLeast squares mean· Baseline, Month 6

Percent Change From Baseline in Femoral Neck BMD at Month 6

GroupValue (percent change)Spread
Abaloparatide1.47900.2714
Placebo-0.18840.3569
Secondary outcomeLeast squares mean· Baseline, Month 12

Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12

GroupValue (percent change)Spread
Abaloparatide1.43580.4236
Placebo-0.19150.5722
Secondary outcomeLeast squares mean· Baseline, Month 12

Percent Change From Baseline in Distal One-third Radius BMD at Month 12

GroupValue (percent change)Spread
Abaloparatide-0.01380.3253
Placebo0.70660.4285

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
AbaloparatideParticipants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen.1 / 1498 / 14973 / 149
PlaceboParticipants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen.0 / 794 / 7929 / 79

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

5 results

The effects of abaloparatide on acetabular bone mineral density and proximal femur strength in men with osteoporosis.

Deal et al. 2026Journal of clinical densitometry : the official journal of the International Society for Clinical Densitometry

PMID 41812602DOI 10.1016/j.jocd.2026.101686PUB-41812602

Full text at the publisher5 results
Publisher pageSee results (5)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 40 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.