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: NA
Product Code: AMG 785
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: AMG 785
Other descriptive name: NA
Concentration unit: m
Sponsors
AMGEN INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 4.1.1 Ambulatory postmenopausal women, age = 60 to = 90 years at randomization 4.1.2 BMD T-score = -2.50 at the total hip or femoral neck and at least one moderate (SQ2) or severe (SQ3) vertebral fracture, as assessed by the central imaging vendor at the time of screening, based on DXA scans and lateral spine x-rays. 4.1.3 At least one hip is evaluable by DXA, as assessed by the principal investigator 4.1.4 Subject has provided informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3850
Exclusion criteria
Exclusion criteria: 4.2.1 Strontium, fluoride (for osteoporosis), odanacatib (MK-0822): at any time 4.2.2 Intravenous (IV) bisphosphonates: dose received within 5 years prior to randomization 4.2.3 Oral bisphosphonates: • More than 3 years of cumulative use • Any dose received within 6 months prior to randomization More than 1 month of cumulative use between 6 and 12 months prior to randomization 4.2.4 Denosumab: dose received within 18 months prior to randomization 4.2.5 Teriparatide or any PTH analogs: dose received within 12 months prior to randomization 4.2.6 Systemic oral or transdermal estrogen, SERMs, or calcitonin: more than 1 month of cumulative use within 6 months prior to randomization 4.2.7 Androgen deprivation or hormonal ablation therapy: more than 1 month of cumulative use within 6 months prior to randomization 4.2.8 Tibolone or cinacalcet: dose received within 3 months prior to randomization 4.2.9 Systemic glucocorticosteroids: = 5 mg prednisone equivalent per day for more than 10 days within 3 months prior to randomization 4.2.10 History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as Paget's disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome 4.2.11 History of solid organ or bone marrow transplants 4.2.12 Vitamin D insufficiency (defined as 25 (OH) vitamin D levels < 20 ng/mL as assessed by the central laboratory. Vitamin D repletion will be permitted and subjects may be rescreened once 4.2.13 Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory 4.2.14 Current, uncontrolled hyper- or hypothyroidism, defined as thyroidstimulating hormone outside of the normal range, per subject report or chart review 4.2.15 Current, uncontrolled hyper- or hypoparathyroidism, defined as PTH outside the normal range, per subject report or chart review 4.2.16 Possible diagnosis of multiple myeloma or related myeloproliferative disorder, as assessed by serum protein electrophoresis performed by the local laboratory 4.2.17 Exclusion criteria related to contraindications or possible signs of intolerance to ALN; contraindications and potential signs of intolerance for ALN therapy include: • Hypocalcemia (as defined in 4.2.13) • 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 ALN or other constituents of ALN tablets • Increased risk of aspiration • Pregnancy and lactation • Other contraindications to ALN based on the country-specific product insert applicable to the specific study center • Significantly impaired renal function (as assessed by the central laboratory based on a derived creatinine clearance of < 35 mL/min using the Modification of Diet in Renal Disease. The estimated glomerular filtration rate is calculated as follows: estimated glomerular filtration rate (mL/min/1.73m2) = 175 x [Serum creatinine (mg/dL)]-1.154 x [Age]-0.203 x [0.742 if subject is female] x [1.210 if subject is black]. 4.2.18 General • Subject is currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) • Su
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: For the overall study period (12-month double-blind alendronate [ALN]- controlled study period followed by the open-label ALN study period) • To assess the effect of AMG 785 treatment for 12 months followed by ALN treatment compared with ALN treatment alone on the subject incidence of clinical fracture (nonvertebral fracture and clinical vertebral fracture) in women with PMO • To assess the effect of AMG 785 treatment for 12 months followed by ALN treatment compared with ALN treatment alone on the subject incidence of new vertebral fracture in women with PMO;Secondary Objective: To assess the effect of AMG 785 treatment for 12 months followed by ALN treatment compared with ALN treatment alone on: • Subject incidence of fractures (all fractures [nonvertebral fractures and new vertebral fractures], new or worsening vertebral fracture, nonvertebral fracture, major nonvertebral fracture [pelvis, distal femur, proximal tibia, ribs, proximal humerus, forearm, and hip], hip fracture, and multiple new or worsening vertebral fracture) • Percent changes in Dual energy X-ray Absorptiometry (DXA) bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck To assess the effect of AMG 785 treatment for 12 months compared with ALN treatment on: • Subject incidence of fractures (clinical fracture [nonvertebral fracture and clinical vertebral fracture], new vertebral fracture, all fractures [nonvertebral fractures and new vertebral fractures]);Primary end point(s): During the overall study period (12-month double-blind ALN-controlled study period followed by the open label ALN study period) • Subject incidence of clinical fracture (nonvertebral fracture and clinical vertebral fracture) at primary analysis • Subject incidence of new vertebral fracture through Month 24;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Month 12 and 24;Secondary end point(s): During the overall study period (12-month double-blind ALN-controlled study period followed by the open-label ALN study period) • Subject incidence of nonvertebral fracture at primary analysis • Subject incidence of all fractures (nonvertebral fracture and new vertebral fracture) at primary analysis • 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) at primary analysis • Subject incidence of hip fracture at primary analysis • Subject incidence of multiple new or worsening vertebral fractures through Month 24 • Percent change from baseline in BMD at the lumbar spine, total hip, and femoral neck at Months 24 and 36 During the 12-month double-blind ALN-controlled study period • Subject incidence of clinical fracture (nonvertebral fracture and clinical vertebral fracture) through Month 12 • Subject incidence of new vertebral fracture through Month 12 • Subject incidence of all fractures (nonvertebral fracture and new vertebral fracture) through Month 12 • Percent change from baseline in BMD at the lumbar spine, total hip and femoral neck at Month 12 | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Slovakia, South Africa, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactDipartimento Regolatorio
Amgen Dompe' SpA
Outcome results
None listed