Postmenopausal Osteoporosis MedDRA version: 14.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: romosozumab
Product Code: AMG785
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: romosozumab
Current Sponsor code: AMG785
Concentration unit: mg/ml
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Ambulatory postmenopausal women, age = 55 to = 90 years at randomization. Postmenopause is defined as no vaginal bleeding or spotting for 12 consecutive months prior to screening. - BMD T-score = -2.50 at the total hip or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans and using data for Caucasian women from the National Health and Nutritional Examination Survey (NHANES) 1998. - At least 2 vertebrae in the L1-L4 region and at least one hip are evaluable by DXA, as assessed by the principal investigator, eg, based on lateral spine x-rays - Subject has provided informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6360
Exclusion criteria
Exclusion criteria: - BMD T-score = -3.50 at the total hip or femoral neck - History of hip fracture - Any severe (SQ3) or more than 2 moderate (SQ2) vertebral fractures Use of the following agents affecting bone metabolism: - Strontium ranelate or fluoride (for osteoporosis): more than one month of cumulative use within 5 years prior to randomization - IV bisphosphonates: • Zoledronic acid: - any dose received within 3 years prior to randomization - more than 1 dose received within 5 years prior to randomization • IV ibandronate or IV pamidronate: - any dose received within 12 months prior to randomization - more than 3 years of cumulative use, unless last dose received = 5 years prior to randomization - Oral bisphosphonates • More than 3 years of cumulative use, unless last dose received = 5 years prior to randomization • Any dose received within 3 months prior to randomization • More than 1 month of cumulative use between 3 and 12 months prior to randomization - Denosumab or any cathepsin K inhibitor, such as odanacatib (MK- 0822): any dose received within 18 months prior to randomization - Teriparatide or any PTH analogs: • any dose received within 3 months prior to randomization • more than 1 month of cumulative use between 3 and 12 months prior to randomization - Systemic oral or transdermal estrogen or SERMs, or calcitonin: more than 1 month of cumulative use within 6 months prior to randomization - Hormonal ablation therapy: more than 1 month of cumulative use within 6 months prior to randomization - Tibolone, cinacalcet or calcitonin: any dose received within 3 months prior to randomization - Systemic glucocorticosteroids: = 5 mg prednisone equivalent per day for more than 14 days within 3 months prior to randomization - History of metabolic or bone disease that may interfere with the interpretation of the results - History of solid organ or bone marrow transplants - History of osteonecrosis of the jaw - Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 20 ng/mL - Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory. Serum calcium levels may be retested once in case of an elevated serum calcium level within 1.1x the upper limit of normal (ULN) as assessed by the central laboratory. - Current, uncontrolled hyper- or hypothyroidism - Current, uncontrolled hyper- or hypoparathyroidism - Possible diagnosis of multiple myeloma or related lymphoproliferative disorder - Contraindicated or intolerant to denosumab therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: For the 12-month double-blind placebo-controlled study period: To assess the effect of romosozumab treatment for 12 months compared with placebo on the subject incidence of new vertebral fracture For the 24-month study period: To assess the effect of romosozumab treatment for 12 months followed by denosumab treatment for 12 months compared to placebo followed by denosumab treatment on the subject incidence of new vertebral fracture.;Secondary Objective: For the 12-month double-blind placebo-controlled study period: • Subject incidence of fractures (clinical fracture, non vertebral fracture, new or worsening vertebral fracture, major non vertebral fracture, hip fracture, major osteoporotic fracture, and multiple new or worsening vertebral fracture) • Percent changes in bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck For the overall 24-month study period (12-month double-blind placebo-controlled study period followed by the 12-month open-label denosumab follow-up study period) - • Subject incidence of fractures (new vertebral fracture, clinical fracture, nonvertebral fracture, new or worsening vertebral fracture, major nonvertebral fracture, hip fracture, major osteoporotic fracture, and multiple new or worsening vertebral fracture) • Percent changes in BMD at the lumbar spine, total hip, and femoral neck;Primary end point(s): During the 12-month double-blind placebo-controlled study period: • Subject incidence of new vertebral fracture through Month 12 During the overall 24-month study period (12-month double-blind placebo-controlled study period followed by the 12-month open-label denosumab follow-up study period): • Subject incidence of new vertebral fracture through Month 24;Timepoint(s) of evaluation of this end point: Months 12 and 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): During the 12-month double-blind placebo-controlled study period: • Subject incidence of clinical fracture (nonvertebral fracture and clinical vertebral fracture) through Month 12 • Subject incidence of nonvertebral fracture through Month 12 • Subject incidence of new or worsening vertebral fracture through Month 12 • Subject incidence of major nonvertebral fracture (pelvis, distal femur, proximal tibia, ribs, proximal humerus, forearm, and hip) through Month 12 • Subject incidence of hip fracture through Month 12 • Subject incidence of major osteoporotic fracture (hip, wrist, humerus, and clinical vertebral) through Month 12 • Subject incidence of multiple new or worsening vertebral fracture through Month 12 • Percent change from baseline in BMD at the lumbar spine, total hip, and femoral neck at Month 12 During the overall 24-month study period (12-month double-blind placebo-controlled study period followed by the 12-month open-label denosumab follow-up study period): • Subject incidence of clinical fracture (nonvertebral fracture and clinical vertebral fracture) through Month 24 • Subject incidence of nonvertebral fracture through Month 24 • Subject incidence of new or worsening vertebral fracture through Month 24 • Subject incidence of major nonvertebral fracture (pelvis, distal femur, proximal tibia, ribs, proximal humerus, forearm, and hip) through Month 24 • Subject incidence of hip fracture through Month 24 • Subject incidence of major osteoporotic fracture (hip, wrist, humerus, and clinical vertebral) through Month 24 • Subject incidence of multiple new or worsening vertebral fracture through Month 24 • Percent change from baseline in BMD at the lumbar spine, total hip, and femoral neck at Month 24 ;Timepoint(s) of evaluation of this end point: Month 12 and 24 | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Colombia, Czech Republic, Denmark, Dominican Republic, Estonia, Germany, Hong Kong, Hungary, India, Japan, Latvia, Lithuania, Mexico, New Zealand, Poland, Romania, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactIHQ-Medical Info - Clinical Trials
Amgen (Europe) GmbH
Outcome results
None listed