Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
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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. |
| ClinicalTrials.gov Identifier: NCT03512262 |
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Recruitment Status :
Active, not recruiting
First Posted : April 30, 2018
Last Update Posted : September 22, 2020
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Sponsor:
Radius Health, Inc.
Information provided by (Responsible Party):
Radius Health, Inc.
- Study Details
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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 |
| 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 |
| Actual Primary Completion Date : | August 20, 2020 |
| Estimated Study Completion Date : | July 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Osteoporosis
Drug Information available for:
Abaloparatide
| Arm | Intervention/treatment |
|---|---|
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Experimental: Abaloparatide (BA058)
Abaloparatide is an active synthetic peptide of parathyroid hormone
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Drug: Abaloparatide
Abaloparatide 80 mcg subcutaneous daily
Other Names:
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Placebo Comparator: Placebo
Placebo with no peptide of parathyroid hormone
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Drug: Placebo
Placebo 0 mcg subcutaneous daily |
Primary Outcome Measures :
- Lumbar spine bone mineral density (BMD) [ Time Frame: 12 months ]Percent change from baseline in lumbar spine BMD
Secondary Outcome Measures :
- Total hip BMD [ Time Frame: 12 months ]Percent change from baseline for total hip BMD
- Femoral neck BMD [ Time Frame: 12 months ]Percent change from baseline for femoral neck BMD
- Lumbar spine BMD [ Time Frame: 6 months ]Percent change from baseline in lumbar spine BMD
- 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
Locations
Show 34 study locations
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 |
| Other Study ID Numbers: |
BA058-05-019 ATOM ( Other Identifier: Radius Health, Inc. ) |
| First Posted: | April 30, 2018 Key Record Dates |
| Last Update Posted: | September 22, 2020 |
| Last Verified: | September 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.:
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BA058 abaloparatide abaloparatide-SC osteoporosis |
male osteoporosis TYMLOS™ fracture bone loss |
Additional relevant MeSH terms:
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Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases |
Abaloparatide Parathyroid Hormone-Related Protein Bone Density Conservation Agents Physiological Effects of Drugs Calcium-Regulating Hormones and Agents |