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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03512262
Recruitment Status : Completed
First Posted : April 30, 2018
Last Update Posted : November 8, 2021
Information provided by (Responsible Party):
Radius Health, Inc.

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

Condition or disease Intervention/treatment Phase
Osteoporosis Osteoporosis, Age-Related Osteoporosis Localized to Spine Age Related Osteoporosis Osteoporosis Senile Osteoporosis of Vertebrae Drug: Abaloparatide Drug: Placebo Phase 3

Detailed Description:
The primary objective of this prospective controlled study is to evaluate the efficacy and the safety of abaloparatide-SC 80 mcg per day compared to placebo as assessed by change in bone mineral density over 12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized patients will received a 2:1 ratio of abaloparatide:placebo injections.
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 patient.
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis
Actual Study Start Date : March 30, 2018
Actual Primary Completion Date : September 8, 2021
Actual Study Completion Date : September 8, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: Abaloparatide (BA058)
Abaloparatide is an active synthetic peptide of parathyroid hormone
Drug: Abaloparatide
Abaloparatide 80 mcg subcutaneous daily
Other Names:
  • BA058
  • abaloparatide-SC

Placebo Comparator: Placebo
Placebo with no peptide of parathyroid hormone
Drug: Placebo
Placebo 0 mcg subcutaneous daily

Primary Outcome Measures :
  1. Lumbar spine bone mineral density (BMD) [ Time Frame: 12 months ]
    Percent change from baseline in lumbar spine BMD

Secondary Outcome Measures :
  1. Total hip BMD [ Time Frame: 12 months ]
    Percent change from baseline for total hip BMD

  2. Femoral neck BMD [ Time Frame: 12 months ]
    Percent change from baseline for femoral neck BMD

  3. Lumbar spine BMD [ Time Frame: 6 months ]
    Percent change from baseline in lumbar spine BMD

  4. Treatment-emergent adverse events (TEAEs) associated with hypercalcemia [ Time Frame: 13 months ]
    Percent of participants reporting TEAE associated with hypercalcemia

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Healthy ambulatory male from 40 to 85 years of age (inclusive) with primary osteoporosis or osteoporosis associated with hypogonadism.
  • The patient has a BMD T-score (based on the female reference range as assessed by the central imaging vendor) of ≤ -2.5 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by 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 (BMI).
  • Hypogonadal patients 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), PTH, serum phosphorus and alkaline phosphatase, and thyroid stimulating hormone (TSH) values.


  • Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal bone mineral density, 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 upon the female reference range.
  • Unevaluable hip BMD or patients 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 (e.g., Paget's disease) other than osteoporosis.
  • Patients 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 patient.
  • History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03512262

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Sponsors and Collaborators
Radius Health, Inc.
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Study Director: Sr. Director, Clinical Operations Radius Health, Inc.
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Responsible Party: Radius Health, Inc. Identifier: NCT03512262    
Other Study ID Numbers: BA058-05-019
ATOM ( Other Identifier: Radius Health, Inc. )
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: November 8, 2021
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radius Health, Inc.:
male osteoporosis
bone loss
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Parathyroid Hormone-Related Protein
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents