Steroid-induced Osteopor, Glucocorticoid-induced Ostepor Clinical Trial
— GIOPOfficial title:
A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals
| Verified date | July 2018 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.
| Status | Completed |
| Enrollment | 795 |
| Est. completion date | June 29, 2017 |
| Est. primary completion date | June 21, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: Men and women 18 years of age or older who have been taking glucocorticoid treatment. Men and women who are less than 50 years of age must have had a fracture as an adult to be eligible. Men and women who are 50 years of age or older who have been taking glucocorticoids must meet protocol-specific BMD criteria. Exclusion Criteria: Use of agents affecting bone metabolism, use of more than one biologic agent for inflammatory disease, history of bone disease (except osteoporosis), low vitamin D level (one can enter the trial after vitamin D levels are corrected), abnormalities of blood calcium, an underactive or overactive thyroid condition that is not treated and stable, Addison's disease, any abnormality of the parathyroid glands (the glands that control blood calcium), currently pregnant or planning a pregnancy, currently breast feeding, and other criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Ciudad Autonoma de Buenos Aires | Buenos Aires |
| Argentina | Research Site | Ciudad Autonoma de Buenos Aires | Buenos Aires |
| Belgium | Research Site | Bruxelles | |
| Belgium | Research Site | Genk | |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | Liege | |
| Belgium | Research Site | Wilrijk | |
| Canada | Research Site | Barrie | Ontario |
| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Saskatoon | Saskatchewan |
| Canada | Research Site | Trois-Rivieres | Quebec |
| Canada | Research Site | Vancouver | British Columbia |
| Canada | Research Site | Waterloo | Ontario |
| Canada | Research Site | Westmout | Quebec |
| Colombia | Research Site | Barranquilla | Atlántico |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Pardubice | |
| Czechia | Research Site | Plzen | |
| Czechia | Research Site | Praha 11 - Chodov | |
| Czechia | Research Site | Praha 2 | |
| Czechia | Research Site | Praha 3 | |
| Czechia | Research Site | Uherske Hradiste | |
| Denmark | Research Site | Aalborg | |
| Denmark | Research Site | Århus C | |
| Denmark | Research Site | Ballerup | |
| Denmark | Research Site | Vejle | |
| France | Research Site | Lyon Cédex 3 | |
| France | Research Site | Orleans Cedex | |
| France | Research Site | Vandoeuvre les Nancy | |
| Germany | Research Site | Bad Nauheim | |
| Germany | Research Site | Bad Reichenhall | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Hildesheim | |
| Germany | Research Site | Köln | |
| Germany | Research Site | Vogelsang-Gommern | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Debrecen | |
| Hungary | Research Site | Gyula | |
| Hungary | Research Site | Szeged | |
| Hungary | Research Site | Szikszo | |
| Korea, Republic of | Research Site | Daegu | |
| Korea, Republic of | Research Site | Daejeon | |
| Korea, Republic of | Research Site | Gwangju | |
| Korea, Republic of | Research Site | Jinju-si | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Mexico | Research Site | Leon | Guanajuato |
| Mexico | Research Site | Mexico | Distrito Federal |
| Mexico | Research Site | Morelia | Michoacán |
| Mexico | Research Site | San Luis Potosi | San Luis Potosí |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Helmond | |
| Netherlands | Research Site | Utrecht | |
| Poland | Research Site | Bialystok | |
| Poland | Research Site | Kraków | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Stalowa Wola | |
| Poland | Research Site | Torun | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Wroclaw | |
| Russian Federation | Research Site | Ekaterinburg | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Nizhniy Novgorod | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Yaroslavl | |
| Spain | Research Site | Barcelona | Cataluña |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Valencia | Comunidad Valenciana |
| United States | Research Site | Beckley | West Virginia |
| United States | Research Site | Bethesda | Maryland |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cumberland | Maryland |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | Duncansville | Pennsylvania |
| United States | Research Site | Evanston | Illinois |
| United States | Research Site | Fargo | North Dakota |
| United States | Research Site | Fargo | North Dakota |
| United States | Research Site | Gainesville | Georgia |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Lakewood | Colorado |
| United States | Research Site | Mayfield | Ohio |
| United States | Research Site | Pembroke Pines | Florida |
| United States | Research Site | Sacramento | California |
| United States | Research Site | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Argentina, Belgium, Canada, Colombia, Czechia, Denmark, France, Germany, Hungary, Korea, Republic of, Mexico, Netherlands, Poland, Russian Federation, Spain,
Saag KG, Wagman RB, Geusens P, Adachi JD, Messina OD, Emkey R, Chapurlat R, Wang A, Pannacciulli N, Lems WF. Denosumab versus risedronate in glucocorticoid-induced osteoporosis: a multicentre, randomised, double-blind, active-controlled, double-dummy, non-inferiority study. Lancet Diabetes Endocrinol. 2018 Jun;6(6):445-454. doi: 10.1016/S2213-8587(18)30075-5. Epub 2018 Apr 6. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis) | Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). | Baseline and month 12 | |
| Secondary | Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Superiority Analysis) | Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). | Baseline and month 12 | |
| Secondary | Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12 | Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA). | Baseline and month 12 | |
| Secondary | Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 24 | Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). | Baseline and month 24 | |
| Secondary | Percent Change From Baseline in Total Hip Bone Mineral Density at Month 24 | Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA). | Baseline and month 24 |