Osteoporosis or Osteopenia MedDRA version: 9.1 Level: LLT Classification code 10049088 Term: Osteopenia MedDRA version: 9.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal
Conditions
Interventions
Product Name: ONO-5334
Pharmaceutical Form: Film-coated tablet
CAS Number: 620614-15-5
Current Sponsor code: ONO-5334
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
Ono Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA FOR THE INITIAL 12-MONTH TREATMENT PHASE 1. Post menopausal women aged between 55 and 75 years old inclusive (55 = age = 75). Post menopausal is defined as more than 5 years after menopause and with Oestradiol and FSH levels consistent with menopause (FSH > 30IU/L, Oestradiol -2.5) at the lumbar spine (L1 to L4) or total hip. 3. Able and willing to give written informed consent. INCLUSION CRITERIA FOR THE 12-MONTH EXTENDED TREATMENT PHASE 1. Patients who have completed the initial 12-month treatment phase of the study. 2. Patients who are able and willing to give written informed consent for the extended treatment phase. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. value of DXA BMD more than 3.5 standard deviation below the young adult mean, (T-score -2.5) who have no vertebral fragility fractures between T4 and L4 inclusive, OR, Osteopenia pts.(T-score -2.5) who have two or more vertebral fragility fractures between T4 and L4 inclusive 4. History of any non-vertebral fragility fractures after age of 50. 5. Abnormalities of the lumbar spine or femoral neck or internal organs around them precluding the assessment of BMD. e.g., A) severe scoliosis. B) two or more vertebral levels in L1, L2, L3, L4 that are not evaluable by DXA due to fracture, metal implants or other orthopaedic procedures etc., C) a previous fracture, severe deformity or metal pins, plates, prostheses, etc., affecting either femur. D) severe osteoarthritis (oeteophytes, sclerosis, etc.) in L1, L2, L3, L4 or femoral neck E) severe aortic calcification interfering with spinal BMD measurement. 6. Clinically relevant fractures 1 year prior to the Randomisation v.(Visit 1). 7. Secondary causes of osteoporosis. e.g., A) Endocrine disorders: thyrotoxicosis, primary hyperparathyroidism, Cushing’s syndrome B) Rheumatologic conditions: RA, ankylosing spondylitis C) Gastro-intestinal disorders: malabsorption partial gastrectomy D) Malignancy: multiple myeloma, metatastic carcinoma E) Drug treatment: systemic oral glucocorticoids, methotrexate, heparin, anti-convulsants F) Genetic disorders:osteogenesis imperfecta G) Nutritional deficiencies:osteomalacia or anorexia H) Immobility I) Other conditions: Diabetes(patients with IDDM, insulin treated or HbA1c =8.0%), hepatic impairment (defined by the exclusion criteria 8), alcohol intake (=20 unit per week) 8. Disorders of bone and mineral metabolism. e.g. A) Vitamin D deficiency (defined as serum 25 hydroxy vitamin D value 12mg/day hydrochlorothiazide or equivalent), Vitamin K (at doses > 200 µg/day) or any medica
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to compare the percentage change in DXA BMD of the lumbar spine between baseline and 12 months following treatment with ONO-5334 or placebo.;Primary end point(s): To compare the percentage change in DXA BMD of the lumbar spine between baseline and 12 months following treatment with ONO-5334 or placebo;Secondary Objective: The following secondary objectives of this trial will be assessed during initial 12-month data: • To compare the effect of ONO-5334 or once weekly Alendronate (Fosamax Once Weekly®) versus placebo on DXA BMD and BMC (Lumbar spine, Total hip, Femoral neck and Trochanter) and biochemical markers of bone turnover from baseline during 12 month treatment. • To compare the proportions of responders to ONO-5334 or Alendronate therapy at the end of 12 months treatment compared with placebo. • To compare the safety and tolerability of ONO-5334 or Alendronate versus placebo. • To compare compliance with treatment with ONO-5334 or Alendronate versus placebo. • To compare the efficacy and safety of ONO-5334 versus Alendronate. • To investigate the efficacy and safety of three different doses of ONO-5334 (50mg BID, 100mg QD, 300mg | — |
Countries
Denmark, Estonia, Hungary, Lithuania, Netherlands
Outcome results
None listed