Postmenopausal osteoporosis MedDRA version: 20.0 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures, or subject’s legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent. • Postmenopausal female (postmenopausal status is defined as no vaginal bleeding or spotting for 12 consecutive months prior to screening). • = 55 to = 90 years of age at the time of informed consent • Ambulatory • BMD T-score = -2.50 at the lumbar spine, total hip, or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans • Subject has at least 2 vertebrae in the L1-L4 region evaluable by DXA, as assessed by the principal investigator or designee • Subject has at least 1 hip evaluable by DXA, as assessed by the principal investigator or designee • Subject has history of fragility (ie, osteoporosis-related fracture) or subject meets at least 2 of the following clinical risk factors for fracture: - = 70 years of age at the time of informed consent - BMD T-score = -3.00 at the lumbar spine, total hip, or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans - current smoker - consumption of = 3 glasses of alcohol a day - parental history of fragility (ie, osteoporosis-related) fracture - body weight = 125 pounds/56 kilogram • Ability to follow and understand instructions and the ability to self-inject, per investigator judgement 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 87 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 173
Exclusion criteria
Exclusion criteria: Disease-Related • History of ONJ and/or AFF • History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as sclerosteosis, Paget’s disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing’s disease, hyperprolactinemia, and malabsorption syndrome • Subject with reported history of hearing loss associated with cranial nerve VIII compression due to excessive bone growth (eg, as seen in conditions such as Paget’s disease, sclerosteosis and osteopetrosis) • Vitamin D insufficiency [defined as serum 25 (OH) vitamin D levels 20% above the upper limit of normal (ULN) in normocalcemic subjects. • 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 ULN as assessed by the central laboratory Other Medical Conditions • Malignancy, except non-melanoma skin cancers or cervical or breast ductal carcinoma in situ within the last 5 years • Possible diagnosis of multiple myeloma or related lymphoproliferative disorder, as assessed by serum protein electrophoresis performed by the central laboratory and interpreted by the investigator • Evidence of acute or chronic hepatitis B or hepatitis C virus. Hepatitis status will be evaluated by testing for hepatitis B surface antigen (HepBsAg), total hepatitis B core antibody (HepBcAb) and hepatitis C antibody by the central laboratory at initial screening. Polymerase chain reaction (PCR) should be performed to confirm active disease only if total HepBcAb is positive and HepBsAg is negative or if C antibody is positive. • Positive for Human Immunodeficiency Virus, per subject report or chart review Prior/Concomitant Therapy • Strontium ranelate or fluoride (for osteoporosis): more than 1 month of cumulative use within 5 years prior to randomization • Intravenous (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 • Dose received within the past 18 months prior to randomization: denosumab or any cathepsin K inhibitor, such as odanacatib (MK-0822) • 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 • Oral bisphosphonates - any dose received
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis either by healthcare provider (HCP) administration with prefilled syringe (PFS) or by subject self-administration with autoinjector/pen (AI/Pen);Secondary Objective: Efficacy • To evaluate the efficacy of a 6-month treatment with 210 mg romosozumab at 90 mg/mL SC M in postmenopausal women with osteoporosis either by HCP administration with PFS or by subject self-administration with AI/Pen Safety • To evaluate the safety and tolerability of a 6-month treatment with 210 mg romosozumab at 90 mg/mL SC QM by HCP administration with PFS or by subject self-administration with AI/Pen Exploratory • To describe the effect of 6 months of treatment with HCP-administered romosozumab with PFS versus subject self-administered romosozumab with AI/Pen SC QM in postmenopausal women with osteoporosis on bone turnover markers (BTMs) • To evaluate serum concentration changes of romosozumab at Months 1, 3, and 6 after SC QM administration of romosozumab;Primary end point(s): • Percent change from baseline in bone mineral density (BMD) at the lumbar spine, as assessed by dual-energy x-ray absorptiometry (DXA);Timepoint(s) of evaluation of this end point: Month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy • Percent changes from baseline in BMD at the total hip and femoral neck by DXA Safety • Incidence of treatment-emergent adverse events, serious adverse events, and adverse device effects • Incidence of subjects developing anti-romosozumab antibodies •Change from baseline in laboratory assessments and vital signs Exploratory • Percent change in bone turnover markers procollagen type 1 N telopeptide (P1NP) and bone resorption marker serum type I collagen C telopeptide (sCTX) • Serum romosozumab concentration at Months 1, 3, and 6;Timepoint(s) of evaluation of this end point: Efficacy: Month 6 (total hip and femoral neck) Exploratory: Months 1, 3, 6 (Serum romosozumab concentration) | — |
Countries
Poland, United Kingdom, United States
Contacts
Public ContactIHQ-Medical Info - Clinical Trials
Amgen (Europe) GmbH
Outcome results
None listed