Clinical trial NCT02186171: A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis in Men
Keywords: Osteoporosis in men
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-07-10
Enrollment: 245
Sex: MALE
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate if treatment with romosozumab once a month for 12 months compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar spine. Additionally, the study will assess the effect of treatment with romosozumab for 12 months compared with placebo on BMD at the femoral neck and total hip.


Eligibility criteria: Inclusion Criteria:

* Must be ambulatory male subjects ≥ 55 years to ≤ 90 years of age
* Must have a BMD T score ≤ -2.50 at the spine or hip, or BMD T score ≤ -1.50 at the spine or hip and a history of fragility nonvertebral fracture or vertebral fracture.

Exclusion Criteria:

* A BMD T score ≤ -3.50 at the hip,
* History of hip fracture
* Severe metabolic bone diseases
* Significant laboratory abnormalities
* Recent treatment with agents affecting bone metabolism

Primary outcomes:
measure: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12
timeFrame: Baseline and month 12
Secondary outcomes:
measure: Percent Change From Baseline in BMD at the Total Hip at Month 12
timeFrame: Baseline and month 12
measure: Percent Change From Baseline in BMD at the Femoral Neck at Month 12
timeFrame: Baseline and month 12
measure: Percent Change From Baseline in Lumbar Spine BMD at Month 6
timeFrame: Baseline and month 6
measure: Percent Change From Baseline in BMD at the Total Hip at Month 6
timeFrame: Baseline and month 6
measure: Percent Change From Baseline in BMD at the Femoral Neck at Month 6
timeFrame: Baseline and month 6
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Research Site
state: Colorado
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Genk
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Medellin
country: Colombia
facility: Research Site
state: Antioquia
city: Bogota
country: Colombia
facility: Research Site
state: Cundinamarca
city: Ostrava-Trebovice
country: Czechia
facility: Research Site
city: Plzen
country: Czechia
facility: Research Site
city: Praha 11 - Chodov
country: Czechia
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Ballerup
country: Denmark
facility: Research Site
city: Mizunami-shi
country: Japan
facility: Research Site
state: Gifu
city: Yokohama-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Bungoono-shi
country: Japan
facility: Research Site
state: Oita
city: Takatsuki-shi
country: Japan
facility: Research Site
state: Osaka
city: Hachioji-shi
country: Japan
facility: Research Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Research Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Research Site
state: Tokyo
city: Mexicali
country: Mexico
facility: Research Site
state: Baja California Norte
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo León
city: Culiacan
country: Mexico
facility: Research Site
state: Sinaloa
city: Lodz
country: Poland
facility: Research Site
city: Swidnik
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Lewiecki EM, Blicharski T, Goemaere S, Lippuner K, Meisner PD, Miller PD, Miyauchi A, Maddox J, Chen L, Horlait S. A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3183-3193. doi: 10.1210/jc.2017-02163.