Glucocorticoid-induced osteoporosis MedDRA version: 17.0 Level: LLT Classification code 10031287 Term: Osteoporosis steroid-induced System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Prolia
Product Name: Denosumab
Product Code: AMG 162
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe
INN or Proposed INN: 615258-40-7
Current Sponsor code: AMG 1
Sponsors
Amgen, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Glucocorticoid-initiating subpopulation: Men and women = 18 years of age who have initiated • prednisone = 7.5 mg daily or its equivalent within 3 months prior to screening and are expected to be treated with oral glucocorticoids for a total of at least 6 months OR - Glucocorticoid-continuing subpopulation: Men and women = 18 years of age who are taking • prednisone = 7.5 mg daily or its equivalent for = 3 months preceding screening and are expected to be treated with oral glucocorticoids for a total of at least 6 months. - Glucocorticoid-continuing subjects who are = 50 years of age will be required to have a BMD value equivalent to a T-score = -2.0 at the lumbar spine, total hip, or femoral neck; or a BMD value equivalent to a T-score = -1.0 at the lumbar spine, total hip, or femoral neck and with a history of osteoporotic fracture. - Men and women =65 years) yes F.1.3.1 Number of subjects for this age range 272
Exclusion criteria
Exclusion criteria: Received other OP treatment or bone active treatment with the following guidelines •Oral bisphosphonate use - >3 months cumulatively in the past 2 years - >1 month in the past yea •Any use during the 3-month period prior to screening •Administration of intravenous bisphosphonate, fluoride or strontium for OP within the last 5 years •Parathyroid hormone (PTH) or PTH derivatives within the last year •Denosumab for OP at any time in the past Administration of any of the following treatment within 3 months of screening: •Any selective estrogen receptor modulator (SERM) (estrogen agonist/antagonist) •Tibolone •Anabolic steroids or testosterone •Systemic hormone replacement therapy •Calcitonin •Other bone active drugs including anti-convulsants (except benzodiazepines) and heparin •Chronic systemic ketoconazole, androgens, adrenocorticotropic hormone (ACTH), cinacalcet, aluminum, lithium, protease inhibitors, gonadotropin-releasing hormone agonists Administration of any of the following biologic agents within 4 weeks prior to screening •Anti alpha 4 integrin antibody (eg, natalizumab) •Anti CD4/CD8 T-cells (eg, alefacept) •Anti IL-12/IL-23 (eg, ustekinumab) •CTLA4 inhibitor (eg, abatacept) •IL1 receptor antagonist (eg, anakinra) •IL6 inhibitor (eg, tocilizumab) •Monoclonal antibody to CD20 (eg, rituximab) •TNF antagonist (eg, adalimumab, certolizumab, golimumab, etanercept, infliximab) •Administering >1 biologic agent for the treatment of underlying inflammatory disease Subject has an active infection or history of infections as follows: •any active infection for which systemic anti-infectives were used within 4 weeks prior to screening •a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to screening •recurrent or chronic infections or other active infection Evidence of any of the following •History of hyperthyroidism(stable on antithyroid therapy is allowed) •History of hypothyroidism(stable on thyroid replacement therapy is allowed) •History of hypo- or hyperparathyroidism •History of Addison disease •History of osteomalacia •History of osteonecrosis of the jaw •History of recent tooth extraction or other dental surgery within the prior 6 months •Invasive dental work planned in the next 2 years •History of Paget’s disease of bone •Other bone diseases which affect bone metabolism Abnormalities of the following per central laboratory reference ranges •Vitamin D deficiency (25[OH] vitamin D level 1.5 x ULN History of any solid organ or bone marrow transplant Contraindicated to, or poorly tolerant of, denosumab therapy. Contraindications include: •Hypocalcemia •Hypersensitivity to drug or any component of the drug Contraindicated to, or poorly tolerant of, risedronate therapy. Contraindications include: •Hypocalcemia •Abnormalities of the esophagus which delay esophageal emptying, such as stricture or achalasia •Inability to stand or sit upright for at least 30 minutes •Hypersensitivity to risedronate or other constituents of risedronate tablets •Significantly impaired renal function as determined by a derived glomerular filtration rate (GFR) Known intolerance to calcium supplements Currently pregnant or planning a pregnancy For women of child bearing potential: Refusal to use 2 highly effective fo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In the glucocorticoid-continuing subpopulation of men and women treated with chronic glucocorticoid therapy (= 7.5 mg daily prednisone or its equivalent for = 3 months and are planning to continue treatment for a total of at least 6 months): is to demonstrate that treatment with denosumab 60 mg subcutaneously (SC) every 6 months (Q6M) is not inferior to treatment with oral risedronate 5 mg every day (QD) with respect to the percent change from baseline in lumbar spine bone mineral density (BMD) by dual X-ray absorptiometry (DXA) at 12 months. In the glucocorticoid-initiating subpopulation of men and women treated with glucocorticoid therapy (= 7.5 mg daily prednisone or its equivalent for < 3 months and are planning to continue treatment for a total of at least 6 months): is to demonstrate that treatment with denosumab 60 mg SC Q6M is not inferior to treatment with oral risedronate 5 mg QD with respect to the percent change from baseline in lumbar spine BMD by DXA at 12 months.;Secondary Objective: To compare the effects of denosumab with that of risedronate separately in the glucocorticoid-continuing and glucocorticoid-initiating subpopulations on: • Percent change from baseline in lumbar spine BMD by DXA at 12 months • Percent change from baseline in total hip BMD by DXA at 12 months • Percent change from baseline in lumbar spine BMD by DXA at 24 months • Percent change from baseline in total hip BMD by DXA at 24 months;Primary end point(s): The primary endpoint in each of the subpopulations is percent change from baseline in lumbar spine BMD by DXA at 12 months (non-inferiority).;Timepoint(s) of evaluation of this end point: month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints to be evaluated in each of the subpopulations separately are: • Percent change from baseline in lumbar spine BMD by DXA at 12 months • Percent change from baseline in total hip BMD by DXA at 12 months • Percent change from baseline in lumbar spineBMD by DXA at 24 months • Percent change from baseline in total hip BMD by DXA at 24 months;Timepoint(s) of evaluation of this end point: months 12 and 24 | — |
Countries
Argentina, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hungary, Korea, Republic of, Mexico, Netherlands, Poland, Russian Federation, Spain, United States
Contacts
Public ContactIHQ Medical Info – Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed