Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
- Conditions
- OsteoporosisOsteoporosis, Age-RelatedOsteoporosis Localized to SpineOsteoporosis SenileAge Related OsteoporosisOsteoporosis of Vertebrae
- Interventions
- Drug: Placebo
- Registration Number
- NCT03512262
- Lead Sponsor
- Radius Health, Inc.
- 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 80 micrograms (mcg) per day administered subcutaneously (SC) compared to placebo in men with osteoporosis. Efficacy was primarily assessed by the change in bone mineral density (BMD) over 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 228
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days. Abaloparatide Abaloparatide Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Lumbar Spine BMD at Month 12 Baseline, Month 12 Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health.
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Total Hip Volumetric BMD as Measured by Quantitative Computed Tomography (QCT) at Month 12 Baseline, Month 12 QCT scans were evaluated by a central imaging laboratory.
Percent Change in Total Hip BMD From Baseline at Month 6 Baseline, Month 6 Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12 Baseline, Month 12 Ultra-distal radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Total Hip BMD at Month 12 Baseline, Month 12 Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Femoral Neck BMD at Month 12 Baseline, Month 12 Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12 Baseline, Month 12 Blood samples were taken to measure s-CTX. Elevated levels of s-CTX indicate increased bone resorption (bone loss).
Number of Participants With New Clinical Fractures Baseline through Month 12 Radiological evaluations were performed to identify any new clinical fractures (occurring after the screening visit).
Percent of Participants With Change in Disease Status Baseline through Month 12 The percentage of participants converting from the categories of osteoporosis to osteopenia or from osteopenia to normal at End of Treatment (Month 12) was assessed. Osteoporosis was defined as lumbar spine or total hip BMD T-score ≤ -2.5. Osteopenia was defined as one of the following:
* Lumbar spine \> -2.5 and total hip BMD T-score \> -2.5 and \< -1.0
* Lumbar spine \> -2.5 and \< -1.0 and total hip BMD T-score \> -2.5
* Normal was defined as lumbar spine and total hip BMD T-score ≥ -1.0.Percent of Participants Experiencing BMD Gains From Baseline of > 0%, > 3%, and > 6% at the Lumbar Spine, Femoral Neck, and Total Hip Month 12 Lumbar spine, femoral neck, and total hip BMD were assessed by DXA scans evaluated by a central imaging laboratory.
Percent Change From Baseline in Femoral Neck Volumetric BMD as Measured by QCT at Month 12 Baseline, Month 12 QCT scans were evaluated by a central imaging laboratory.
Percent Change From Baseline in Lumbar Spine BMD at Month 6 Baseline, Month 6 Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12 Baseline, Month 12 Blood samples were taken to measure s-PINP, a bone formation marker. s-PINP concentrations reflect the rate of skeletal new bone formation. Increases in s-PINP indicate anabolic biologic response in the bone.
Percent Change From Baseline in Femoral Neck BMD at Month 6 Baseline, Month 6 Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Distal One-third Radius BMD at Month 12 Baseline, Month 12 Distal one-third radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health.
Trial Locations
- Locations (34)
Meridian Clinical Research
🇺🇸Savannah, Georgia, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Centex Studies, Inc.
🇺🇸Houston, Texas, United States
PMG Research of Cary, LLC
🇺🇸Cary, North Carolina, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Baptist Diabetes Associates, Pa
🇺🇸Miami, Florida, United States
ClinicMed Daniluk, Nowak Sp.j.
🇵🇱Białystok, Poland
Zdrowie Osteo-Medic s.c. Lidia I Artur Racewicz, Agnieszka I Jerzy Supronik
🇵🇱Białystok, Podlaskie, Poland
Lubelskie Centrum Diagnostyczne
🇵🇱Swidnik, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
🇵🇱Warszawa, Mazowieckie, Poland
MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
🇺🇸Washington, District of Columbia, United States
NZOZ Nasz Lekarz
🇵🇱Toruń, Poland
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Marin Endocrine Care & Research, Inc.
🇺🇸Greenbrae, California, United States
Alta California Medical Group
🇺🇸Simi Valley, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Indago Research & Health Center, Inc.
🇺🇸Hialeah, Florida, United States
Panorama Orthopedics & Spine Center
🇺🇸Golden, Colorado, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Center For Advanced Research & Education
🇺🇸Gainesville, Georgia, United States
PMG Research of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States
Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
🇮🇹Siena, Toscana, Italy
Altoona Center For Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Azienda ospedaliera universitaria Careggi
🇮🇹Florence, Tuscany, Italy
Azienda ospedaliera universitaria integrata di verona(AOUI)
🇮🇹Verona, Italy
Krakowskie Centrum Medyczne Sp. z o.o.
🇵🇱Kraków, Malopolskie, Poland
ETG Siedlce
🇵🇱Siedlce, Poland
Synexus Polska Sp z o.o Oddzial we Wroclawiu
🇵🇱Wrocław, Poland
Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci
🇵🇱Łódź, Poland
Hunter Holmes McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
New Mexico Clinical Research & Osteoporosis Center, Inc.
🇺🇸Albuquerque, New Mexico, United States
University of Wisconsin Osteoporosis Clinical Research Program
🇺🇸Madison, Wisconsin, United States
Centex Studies, Inc
🇺🇸McAllen, Texas, United States