Osteoporosis in postmenopausal women MedDRA version: 9.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal
Conditions
Interventions
Product Name: JTT-305
Product Code: JTT-305
Pharmaceutical Form: Tablet
CAS Number: 787584-79-6
Current Sponsor code: JTT-305
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
Akros Pharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ambulatory postmenopausal women, between 45-80 years of age (inclusive) at the Screening Visit (Visit 1), who are able to provide written informed consent; 2. Females who are currently postmenopausal as defined by: • No menstrual cycle for 60 consecutive months and no other biological or physiological cause for this phenomenon can be identified, or • A medical history of bilateral oophorectomy occurring at least 60 months prior to the Screening Visit; 3. A body mass index (BMI) between 18-32 kg/m2 (inclusive) at the Screening Visit; 4. Body weight > 40 kg at the Screening Visit; 5. A bone mineral density (BMD) T-score of = -2.5 (BMD = 0.880 g/cm2) at the lumbar spine, or BMD T-score = -2.0 (BMD = 0.940 g/cm2) at the lumbar spine with at least one of the following: at least 65 years of age, history of at least 10 consecutive years of smoking, BMI =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. More than one severe fracture or more than two mild or moderate fractures in T4 – L4 at the Screening Visit (see Appendix 1 for the grading scale); 2. A BMD T-score of 2.55 mmol/L, or serum phosphorus levels = 1.61 mmol/L or = 0.80 mmol/L at the Screening Visit; 6. Abnormal reference laboratory values for intact parathyroid hormone or thyroid stimulating hormone (TSH) at the Screening Visit; 7. Abnormal liver functions as measured by AST or ALT > 1.5 x ULN, or total bilirubin > 2.0 x ULN at the Screening Visit; 8. A serum follicle stimulating hormone (FSH) level 8%), or current use of insulin (see Appendix 2); 18. Current, or a history of (within the previous five years), calcium-containing nephrolithiasis or urolithiasis, or significant renal impairment (e.g., serum creatinine > 177 µmol/L); 19. A clinically relevant history of, in the opinion of the Investigator, or presence of cardiovascular, dermatological, endocrinological, gastrointestinal, hematological, hepatic, immunological, lymphatic, musculoskeletal, neurological, psychiatric, renal, or respiratory disease; 20. Current, or a history of (within the previous five years), malignancy (except for treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix); 21. Previous skeletal exposure to external beam radiotherapy (i.e., radiation therapy); 22. A significant history of drug sensitivities (i.e. multiple drug allergies or severe allergic reactions) in the opinion of the Investigator; 23. Hypersensitivity to any component of JTT-305, Calcichew-D3 Forte®, or D3-Vitamin® formulations, in the opinion of the Investigator; 24. Cannot communicate reliably with the I
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of JTT-305 on the changes in lumbar spine bone mineral density (BMD), as determined by dual energy X-ray absorptiometry (DXA), when administered for 24 weeks to postmenopausal women with osteoporosis.;Secondary Objective: • To determine the effect of JTT-305 on the changes in hip BMD (femoral neck, shaft, trochanter, total hip), as determined by DXA, when administered for 24 weeks to postmenopausal women with osteoporosis. • To determine the effect of JTT-305 on the changes in bone turnover markers when administered for 24 weeks to postmenopausal women with osteoporosis. • To examine the safety profile of JTT-305 when administered for 24 weeks to postmenopausal women with osteoporosis.;Primary end point(s): The primary efficacy endpoint is the percent change from baseline to the end of treatment (EOT) in lumbar spine BMD. | — |
Countries
Denmark
Outcome results
None listed