Post Menospausal Osteoporosis MedDRA version: 16.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: denosumab (manufactured using new process CP4)
Pharmaceutical Form: Solution for injection in pre-filled syringe
CAS Number: 615258-40-7
Other descriptive name: DENOSUMAB
Concentration u
Sponsors
Amgen, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Ambulatory postmenopausal women. Ambulatory is defined as women who are able to walk, not bedridden; postmenopause is defined as no vaginal bleeding or spotting for at least 12 months prior to screening. • Age = 55 years • Screening bone mineral density (g/cm2) values (by DXA) at the lumbar spine values equal to or less than 0.880 GE Lunar, 0.772 Hologic. Screening bone mineral density (g/cm2) values (by DXA) at the total hip values equal to or less than 0.693 GE Lunar, 0.637 Hologic. Screening bone mineral density (g/cm2) values (by DXA) at the femoral neck values equal to or less than 0.692 GE Lunar, 0.558 Hologic. Both the initial and the repeat DXA assessments at baseline of the lumbar spine OR the total hip OR the femoral neck must meet the above eligibility criteria. Eligibility will be determined by a local reading of the DXAs at the investigator's site. At least 2 lumbar vertebrae must be evaluable by DXA. • 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. 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: • Height, weight, or girth which may preclude accurate DXA measurements • Received other osteoporosis treatment or bone active treatment with the following guidelines: - Administration of the following within the last 5 years . intravenous bisphosphonate . denosumab . fluoride for osteoporosis . strontium salts . PTH or PTH derivatives • Administration or oral bisphosphonates . > 3 years cumulatively, OR . > 3 months and = 3 years cumulatively, unless treatment was discontinued = 1 year prior to screening • Administration of any of the following treatment within the last 3 months: . SERM (selective estrogen receptor modulator) . tibolone . anabolic steroids or testosterone . glucocorticosteroids (=5 mg prednisone equivalent per day for > 10 days or a total cumulative dose of = 50 mg) . systemic hormone replacement therapy (HRT) (subjects stable on HRT for > 3 months prior are permitted) . antisclerostin antibody . calcitonin . other bone active drugs including anticonvulsants (except benzodiazepines, gabapentin) and heparin . cathepsin K inhibitor . chronic systemic ketoconazole, androgens, adreno corticotrophic hormone (ACTH), cinacalcet, aluminum, lithium, protease inhibitors, gonadotropin releasing hormone agonists • Evidence of history of any of the following: . Current uncontrolled hypo- or hyperthyroidism (subjects who have controlled hypo- or hyperthyroidism may be eligible, provided that they have been on a stable therapy for at least 3 months (per subject report)). . hypo- or hyperparathyroidism . known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen . osteomalacia (chart review) . osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (eg, dental implants, oral surgery in the past 6 months), poor oral hygiene, periodontal and/or pre-existing dental disease . recent tooth extraction (within 6 months of screening visit) . Paget's disease of bone (subject report or chart review) . Rheumatoid arthritis . other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta) (chart review) • Vitamin D deficiency (25[OH] vitamin D level < 20 ng/mL) • Creatinine clearance (calculated using the Cockcroft-Gault equation) of < 30 mL/min, or evidence of acute renal impairment • Abnormalities of the following per central laboratory reference ranges: . hypocalcemia or hypercalcemia . elevated transaminases = 2.0 x upper limits of normal (ULN) • History of any solid organ or bone marrow transplant • Malignancy within the last 5 years (except squamous cell carcinoma, basal cell carcinoma, or cervical or breast ductal carcinoma in situ) • Contraindicated or poorly tolerant of denosumab therapy; contraindications include . hypocalcemia . hypersensitivity to drug or any component of the drug • Known intolerance to calcium or vitamin D supplements • Self reported alcohol or drug abuse within 12 months prior to screening • Any disorder that compromises ability to give truly informed consent for participation in this study • Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s) • Subject has known sensitivity to any of the products to be administered during dosing • Subject likely to not be available to complete all protocol-required stu
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percent change from baseline in bone turnover markers (serum CTX and P1NP) at 1, 6 and 12 months;Timepoint(s) of evaluation of this end point: At 1, 6 and 12 months | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to evaluate 1. whether the efficacy of denosumab (60 mg subcutaneously every 6 months) manufactured by the proposed process referred to as CP4 is not inferior to that of denosumab manufactured by the currently approved commercial process referred to as CP2 based on the change in lumbar spine bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) at 12 months in postmenopausal women with osteoporosis; 2. whether the efficacy of denosumab CP4 (60 mg subcutaneously every 6 months) is equivalent to that of denosumab CP2 based on the change in lumbar spine BMD by DXA at 12 months in postmenopausal women with osteoporosis.;Secondary Objective: To compare the change in bone turnover marker levels over 12 months in subjects administered denosumab manufactured by 2 different processes in postmenopausal women with osteoporosis.;Primary end point(s): Percent change from baseline in lumbar spine BMD at 12 months;Timepoint(s) of evaluation of this end point: at 12 months | — |
Countries
Canada, Czech Republic, Denmark, Poland, United States
Contacts
Public ContactIHQ-Medical Info - Clinical Trials
Amgen (Europe) GmbH
Outcome results
None listed