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

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ClinicalTrials.gov Identifier: NCT03512262
Recruitment Status : Recruiting
First Posted : April 30, 2018
Last Update Posted : April 30, 2018
Sponsor:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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 Name: TYMLOS™, abaloparatide-SC, BA058

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



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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
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT03512262


Contacts
Contact: Radius Health, Inc. 617-551-4002 info@radiuspharm.com

Locations
United States, Massachusetts
Radius Health, Inc. Recruiting
Waltham, Massachusetts, United States, 02451
Contact: Study Director         
Sponsors and Collaborators
Radius Health, Inc.
Investigators
Study Director: Sr. Director, Clinical Operations Radius Health, Inc.

Publications:
Responsible Party: Radius Health, Inc.
ClinicalTrials.gov Identifier: NCT03512262     History of Changes
Other Study ID Numbers: BA058-05-019
ATOM ( Other Identifier: Radius Health, Inc. )
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Radius Health, Inc.:
BA058
abaloparatide
abaloparatide-SC
osteoporosis
male osteoporosis
TYMLOS™
fracture
bone loss

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases