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

Sponsor
Radius Health, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03512262
Collaborator
(none)
228
34
2
41.3
6.7
0.2

Study Details

Study Description

Brief Summary

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

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.

Study Design

Study Type:
Interventional
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.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 :
Mar 30, 2018
Actual Primary Completion Date :
Sep 8, 2021
Actual Study Completion Date :
Sep 8, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Abaloparatide (BA058)

Abaloparatide is an active synthetic peptide of parathyroid hormone

Drug: Abaloparatide
Abaloparatide 80 mcg subcutaneous daily
Other Names:
  • TYMLOS®
  • BA058
  • abaloparatide-SC
  • Placebo Comparator: Placebo

    Placebo with no peptide of parathyroid hormone

    Drug: Placebo
    Placebo 0 mcg subcutaneous daily

    Outcome Measures

    Primary Outcome Measures

    1. Lumbar spine bone mineral density (BMD) [12 months]

      Percent change from baseline in lumbar spine BMD

    Secondary Outcome Measures

    1. Total hip BMD [12 months]

      Percent change from baseline for total hip BMD

    2. Femoral neck BMD [12 months]

      Percent change from baseline for femoral neck BMD

    3. Lumbar spine BMD [6 months]

      Percent change from baseline in lumbar spine BMD

    4. Treatment-emergent adverse events (TEAEs) associated with hypercalcemia [13 months]

      Percent of participants reporting TEAE associated with hypercalcemia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 85 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

    INCLUSION CRITERIA

    • 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.

    EXCLUSION CRITERIA

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 Marin Endocrine Care & Research, Inc. Greenbrae California United States 94904
    3 Alta California Medical Group Simi Valley California United States 93065
    4 Diablo Clinical Research, Inc. Walnut Creek California United States 94598
    5 Panorama Orthopedics & Spine Center Golden Colorado United States 80401
    6 MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH) Washington District of Columbia United States 20007
    7 Indago Research & Health Center, Inc. Hialeah Florida United States 33012
    8 Baptist Diabetes Associates, Pa Miami Florida United States 33156
    9 Center For Advanced Research & Education Gainesville Georgia United States 30501
    10 Meridian Clinical Research Savannah Georgia United States 31406
    11 Northwestern University Chicago Illinois United States 60611
    12 The University of Chicago Chicago Illinois United States 60637
    13 New Mexico Clinical Research & Osteoporosis Center, Inc. Albuquerque New Mexico United States 87106
    14 SUNY Upstate Medical University Syracuse New York United States 13210
    15 PMG Research of Cary, LLC Cary North Carolina United States 27518
    16 PMG Research of Wilmington, LLC Wilmington North Carolina United States 28401
    17 Ohio State University Medical Center Columbus Ohio United States 43210
    18 Altoona Center For Clinical Research Duncansville Pennsylvania United States 16635
    19 Centex Studies, Inc. Houston Texas United States 77058
    20 Centex Studies, Inc McAllen Texas United States 78504
    21 Hunter Holmes McGuire VA Medical Center Richmond Virginia United States 23249
    22 University of Wisconsin Osteoporosis Clinical Research Program Madison Wisconsin United States 53705
    23 Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte Siena Toscana Italy 53100
    24 Azienda ospedaliera universitaria Careggi Florence Tuscany Italy 50139
    25 Azienda ospedaliera universitaria integrata di verona(AOUI) Verona Italy 37134
    26 Krakowskie Centrum Medyczne Sp. z o.o. Kraków Malopolskie Poland 31-501
    27 Synexus Polska Sp. z o.o. Oddzial w Warszawie Warszawa Mazowieckie Poland 01-192
    28 Zdrowie Osteo-Medic s.c. Lidia I Artur Racewicz, Agnieszka I Jerzy Supronik Białystok Podlaskie Poland 15-351
    29 ClinicMed Daniluk, Nowak Sp.j. Białystok Poland 15-879
    30 ETG Siedlce Siedlce Poland 08-110
    31 Lubelskie Centrum Diagnostyczne Swidnik Poland 21-040
    32 NZOZ Nasz Lekarz Toruń Poland 87100
    33 Synexus Polska Sp z o.o Oddzial we Wroclawiu Wrocław Poland 50-381
    34 Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci Łódź Poland 90-558

    Sponsors and Collaborators

    • Radius Health, Inc.

    Investigators

    • Study Director: Sr. Director, Clinical Operations, Radius Health, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Radius Health, Inc.
    ClinicalTrials.gov Identifier:
    NCT03512262
    Other Study ID Numbers:
    • BA058-05-019
    • ATOM
    First Posted:
    Apr 30, 2018
    Last Update Posted:
    Nov 8, 2021
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Radius Health, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 8, 2021