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
Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients may be included in this study only if they meet all of the following criteria: a. The patient provides a signed and dated written informed consent. b. The patient is a clinically stable, ambulatory, female postmenopausal adult (=60 and =90 years) with a diagnosis of osteoporosis. c. The patient is of postmenopausal status, defined as: Spontaneous amenorrhea for >12 months, or Spontaneous amenorrhea >6 months and serum follicle stimulating hormone (FSH) and estradiol (E2) in menopausal range, or Surgical menopause at least 6 weeks before the start of screening. d. The patient has a body weight =50 kg and =90 kg (=110 lb and =198 lb) at screening. e. The patient agrees to be supplemented with 1000 mg calcium and at least 400 IU vitamin D daily from screening until the last visit. f. The patient has a BMD-measurement T-score of less than -2.5 but not less than -4.0 by dual energy X-ray absorptiometry (DXA) at the lumbar spine at screening based on central reader assessment. g. The patient has at least three (3) vertebrae in the L1-L4 region that are evaluable by DXA. h. The patient has serum 25 (OH) vitamin D level >20 ng/mL at screening and no current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory. Vitamin D and calcium supplements will be provided and patients may be rescreened once to re-evaluate calcium and/or vitamin D level post repletion. i. The patient must be willing and able to comply with study restrictions and to remain at the investigational center for the required duration during the study period, and willing to return to the investigational center for further visits, as applicable, and the follow-up procedures and assessments as specified in this protocol. 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 65 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 261
Exclusion criteria
Exclusion criteria: Patients will be excluded from participating in this study if they meet any of the following criteria: a. The patient has a known malabsorption of calcium or vitamin D supplements. b. The patient has a metabolic or bone disease (except osteoporosis) such as Paget’s disease, Cushing’s disease, rheumatoid arthritis, sclerosteosis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, hyperprolactinemia, malabsorption syndrome, osteomyelitis, multiple myeloma or related lymphoproliferative disorder, or bone metastases. c. The patient has a current, uncontrolled hyperthyroidism or hypothyroidism, per patient report or chart review. d. The patient has hypoparathyroidism or hyperparathyroidism (irrespective of current controlled or uncontrolled status). e. The patient has a history and/or presence of risk factors of osteonecrosis of the jaw, as determined by the principal investigator, (eg, unhealed open soft tissue lesions in the mouth, poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, recent or planned invasive dental procedures such as tooth extractions within the next 18 months), presence of anemia or coagulopathy at screening, and/or inability to maintain oral hygiene during the study. f. The patient has a history and/or presence of 1 severe or more than 2 moderate vertebral fractures (as determined by central reading of lateral spine X-ray during the screening period). g. The patient has a history and/or presence of hip fracture or atypical femur fracture. h. The patient has participated in another study of an IMP (or a medical device) within the previous 30 days or 5 half-lives of the IMP (whichever is longer) or longer if required by local regulations, or is currently participating in another study of an IMP (or a medical device). i. The patient has a known hypersensitivity to any components of the IMPs stated in this protocol or to calcium or vitamin D. j. The patient has a renal impairment manifested with an estimated glomerular filtration rate (eGFR) 3 years before the start of screening. s. The patient has ong
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate that there are no clinically meaningful differences in efficacy between TVB-009P and PROLIA US administered subcutaneously in patients with postmenopausal osteoporosis.;Secondary Objective: A secondary objective is to compare: - further efficacy and pharmacodynamic parameters between TVB-009P and PROLIA US. - efficacy and pharmacodynamic parameters between TVB-009P and PROLIA US after a single transition from PROLIA US to TVB-009P. - the safety and tolerability, including device-related events, between TVB-009P and PROLIA US throughout the study. - the safety and tolerability between TVB-009P and PROLIA US after a single transition from PROLIA US to TVB-009P, including device-related events. A secondary objective of this study is to assess the immunogenicity of TVB-009P: - in comparison with PROLIA US throughout the study. - in comparison with PROLIA US after a single transition from PROLIA US to TVB-009P. ;Primary end point(s): The primary efficacy endpoint is: - the percent change from baseline in lumbar spine-bone mineral density (LS-BMD) at week 52 based on centrally assessed dual-energy X-ray absorptiometry (DXA) measurements - The co-primary efficacy endpoint for the European Union (EU) submission is the percent change from baseline in serum C-telopeptide cross-link of type 1 collagen (sCTX-1) at week 26. For the EU submission, this endpoint is regarded as co-primary. For the United States (US) submission, this endpoint is regarded as secondary ;Timepoint(s) of evaluation of this end point: week 26 and week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy and pharmacodynamic endpoints are: - percent change from baseline in LS-BMD at week 26 based on centrally assessed DXA measurements - percent change from baseline in femoral neck bone mineral density (BMD) by DXA at week 26 and at week 52 - percent change from baseline in total hip BMD by DXA at week 26 and at week 52 - percent change from baseline in sCTX-1 at all time points - sCTX-1 suppression at week 4 - percent change from baseline in procollagen type 1 N propeptide (P1NP) at week 26 and week 52 - incidence of fractures up to week 52 The pharmacodynamic/efficacy endpoints in the transition period are: - percent change from week 52 in LS-BMD by DXA at week 78 - difference between percent change from baseline in sCTX-1 between week 52 and week 78 - percent change from week 52 in femoral neck BMD by DXA at week 78 - percent change from week 52 in total hip BMD by DXA at week 78 - difference between percent change from baseline in P1NP between week 52 and week 78 - incidence of fractures up to week 78 The safety and tolerability endpoints are: - adverse events (and the number of patients who withdraw from the study due to adverse events) - vital signs - laboratory tests (hematology, serum chemistry, and urinalysis) - electrocardiogram (ECG) - local tolerability at injection site - use of concomitant medications - device-related adverse events and malfunctions The immunogenicity endpoint is: - incidence of patients with confirmed positive anti-drug antibody (ADA) sample For confirmed positive samples, the ADA titer and the neutralizing potential will be tested. The effect of positive immunogenicity findings on pharmacokinetics, efficacy, and safety will be assessed if applicable. ;Timepoint(s) of evaluation of this end point: week 26, 52 and 78 | — |
Countries
Bulgaria, Czechia, Czech Republic, Georgia, Germany, Hungary, Poland, Russian Federation, Slovakia, Ukraine, United States
Contacts
Public ContactClinical Trials Department
SanaClis s.r.o.
Outcome results
None listed