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

NCT03512262 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2023-04-07

Study results available
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Summary

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

Conditions

  • Osteoporosis
  • Osteoporosis, Age-Related
  • Osteoporosis Localized to Spine
  • Age Related Osteoporosis
  • Osteoporosis Senile
  • Osteoporosis of Vertebrae

Interventions

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.

Sponsors & Collaborators

  • Radius Health, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-03
Primary Completion
2021-08-17
Completion
2021-09-08
FDA Drug
Yes

Countries

  • United States
  • Italy
  • Poland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03512262 on ClinicalTrials.gov