Osteoporosis in Men Clinical Trial
— BRIDGEOfficial title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
| Verified date | May 2019 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 245 |
| Est. completion date | April 20, 2016 |
| Est. primary completion date | February 15, 2016 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 55 Years to 90 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Research Site | Genk | |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | Leuven | |
| Belgium | Research Site | Liège | |
| Colombia | Research Site | Bogota | Cundinamarca |
| Colombia | Research Site | Medellin | Antioquia |
| Czechia | Research Site | Ostrava-Trebovice | |
| Czechia | Research Site | Plzen | |
| Czechia | Research Site | Praha 11 - Chodov | |
| Denmark | Research Site | Aalborg | |
| Denmark | Research Site | Ballerup | |
| Japan | Research Site | Bungoono-shi | Oita |
| Japan | Research Site | Hachioji-shi | Tokyo |
| Japan | Research Site | Mizunami-shi | Gifu |
| Japan | Research Site | Shinagawa-ku | Tokyo |
| Japan | Research Site | Takatsuki-shi | Osaka |
| Japan | Research Site | Toshima-ku | Tokyo |
| Japan | Research Site | Yokohama-shi | Kanagawa |
| Mexico | Research Site | Culiacan | Sinaloa |
| Mexico | Research Site | Mexicali | Baja California Norte |
| Mexico | Research Site | Monterrey | Nuevo León |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Swidnik | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Wroclaw | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Yaroslavl | |
| Switzerland | Research Site | Bern | |
| Switzerland | Research Site | Zurich | |
| Switzerland | Research Site | Zurich | |
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Bethesda | Maryland |
| United States | Research Site | Lakewood | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Belgium, Colombia, Czechia, Denmark, Japan, Mexico, Poland, Russian Federation, Switzerland,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12 | Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and month 12 | |
| Secondary | Percent Change From Baseline in BMD at the Total Hip at Month 12 | Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and month 12 | |
| Secondary | Percent Change From Baseline in BMD at the Femoral Neck at Month 12 | Femoral neck bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and month 12 | |
| Secondary | Percent Change From Baseline in Lumbar Spine BMD at Month 6 | Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and month 6 | |
| Secondary | Percent Change From Baseline in BMD at the Total Hip at Month 6 | Bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and month 6 | |
| Secondary | Percent Change From Baseline in BMD at the Femoral Neck at Month 6 | Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and month 6 |