Clinical trial NCT03512262: Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Osteoporosis, Age-Related
Osteoporosis Localized to Spine
Age Related Osteoporosis
Osteoporosis Senile
Osteoporosis of Vertebrae
Keywords: BA058
abaloparatide
abaloparatide-SC
osteoporosis
male osteoporosis
TYMLOS®
fracture
bone loss
Lead sponsor: Radius Health, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-30
Enrollment: 228
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in a 2:1 treatment ratio (abaloparatide:placebo).
Primary purpose: TREATMENT

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.

Eligibility criteria: Key Inclusion Criteria

* Healthy ambulatory male from 40 to 85 years of age (inclusive) with primary osteoporosis or osteoporosis associated with hypogonadism.
* The participant has a BMD T-score based on female or male reference range (depending on date of enrollment) as assessed by the central imaging vendor of ≤ -2.5 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (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.
* Hypogonadal participants 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), parathyroid hormone, serum phosphorus and alkaline phosphatase, and thyroid stimulating hormone values.

Key Exclusion Criteria

* Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal BMD, 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 on female or male reference range (depending on date of enrollment).
* Unevaluable hip BMD or participants 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 (for example, Paget's disease) other than osteoporosis.
* participant 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 participant.
* History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year.

Primary outcomes:
measure: Percent Change From Baseline in Lumbar Spine BMD at Month 12
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Percent Change From Baseline in Total Hip BMD at Month 12
timeFrame: Baseline, Month 12
measure: Percent Change From Baseline in Femoral Neck BMD at Month 12
timeFrame: Baseline, Month 12
measure: Percent Change From Baseline in Lumbar Spine BMD at Month 6
timeFrame: Baseline, Month 6
measure: Percent Change in Total Hip BMD From Baseline at Month 6
timeFrame: Baseline, Month 6
measure: Percent Change From Baseline in Femoral Neck BMD at Month 6
timeFrame: Baseline, Month 6
measure: Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12
timeFrame: Baseline, Month 12
measure: Percent Change From Baseline in Distal One-third Radius BMD at Month 12
timeFrame: Baseline, Month 12
measure: Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12
timeFrame: Baseline, Month 12
measure: Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12
timeFrame: Baseline, Month 12
measure: Number of Participants With New Clinical Fractures
timeFrame: Baseline through Month 12
measure: Percent of Participants With Change in Disease Status
timeFrame: Baseline through Month 12
measure: Percent of Participants Experiencing BMD Gains From Baseline of > 0%, > 3%, and > 6% at the Lumbar Spine, Femoral Neck, and Total Hip
timeFrame: Month 12
measure: Percent Change From Baseline in Total Hip Volumetric BMD as Measured by Quantitative Computed Tomography (QCT) at Month 12
timeFrame: Baseline, Month 12
measure: Percent Change From Baseline in Femoral Neck Volumetric BMD as Measured by QCT at Month 12
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Greenbrae
country: United States
facility: Marin Endocrine Care & Research, Inc.
state: California
city: Simi Valley
country: United States
facility: Alta California Medical Group
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Golden
country: United States
facility: Panorama Orthopedics & Spine Center
state: Colorado
city: Washington
country: United States
facility: MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
state: District of Columbia
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc.
state: Florida
city: Miami
country: United States
facility: Baptist Diabetes Associates, Pa
state: Florida
city: Gainesville
country: United States
facility: Center For Advanced Research & Education
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center, Inc.
state: New Mexico
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Cary
country: United States
facility: PMG Research of Cary, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Houston
country: United States
facility: Centex Studies, Inc.
state: Texas
city: McAllen
country: United States
facility: Centex Studies, Inc
state: Texas
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Osteoporosis Clinical Research Program
state: Wisconsin
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
state: Toscana
city: Florence
country: Italy
facility: Azienda ospedaliera universitaria Careggi
state: Tuscany
city: Verona
country: Italy
facility: Azienda ospedaliera universitaria integrata di verona(AOUI)
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z o.o.
state: Malopolskie
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie
state: Mazowieckie
city: Białystok
country: Poland
facility: Zdrowie Osteo-Medic s.c. Lidia I Artur Racewicz, Agnieszka I Jerzy Supronik
state: Podlaskie
city: Białystok
country: Poland
facility: ClinicMed Daniluk, Nowak Sp.j.
city: Siedlce
country: Poland
facility: ETG Siedlce
city: Swidnik
country: Poland
facility: Lubelskie Centrum Diagnostyczne
city: Toruń
country: Poland
facility: NZOZ Nasz Lekarz
city: Wrocław
country: Poland
facility: Synexus Polska Sp z o.o Oddzial we Wroclawiu
city: Łódź
country: Poland
facility: Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci
Study officials:
References:
citation: Rizzoli R, Bonjour JP, Ferrari SL. Osteoporosis, genetics and hormones. J Mol Endocrinol. 2001 Apr;26(2):79-94. doi: 10.1677/jme.0.0260079.
citation: Mannstadt M, Juppner H, Gardella TJ. Receptors for PTH and PTHrP: their biological importance and functional properties. Am J Physiol. 1999 Nov;277(5):F665-75. doi: 10.1152/ajprenal.1999.277.5.F665.
citation: Dempster DW, Cosman F, Parisien M, Shen V, Lindsay R. Anabolic actions of parathyroid hormone on bone. Endocr Rev. 1993 Dec;14(6):690-709. doi: 10.1210/edrv-14-6-690. No abstract available.