A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study Evaluating the Efficacy and Safety of JTT-305 Administered for Six Months in Postmenopausal Women with Osteoporosis
- Conditions
- Osteoporosis in postmenopausal womenMedDRA version: 9.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausal
- Registration Number
- EUCTR2007-005474-31-DK
- Lead Sponsor
- Akros Pharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 220
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 < 20 kg/m2, history of postmenopausal osteoporotic fracture (vertebral or non-vertebral), or maternal history of osteoporotic fracture (vertebral or non-vertebral), at the Screening Visit;
6. Vitamin D (25-OH-D) levels = 50 nmol/L prior to Visit 5;
7. Have at least two evaluable vertebrae in L1 - L4 for BMD measurements by DXA.
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
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 < -4.0 (BMD < 0.700 g/cm2) at the lumbar spine or a BMD T-score of < -4.0 at the hip (average of two measurements of either the total hip [BMD < 0.520 g/cm2] or femoral neck [BMD < 0.500 g/cm2]);
3. Severe calcification on ligaments around L1 – L4 and/or on abdominal aorta, or excessive degenerative disease (e.g., osteophytes, sclerosis) which precludes accurate measurement of lumbar spine BMD in at least two vertebrae;
4. Secondary osteoporosis (i.e., osteoporosis due to underlying diseases or chronic conditions that contribute to accelerated bone loss, including (but not limited to) genetic disorders, hypogonadal states, endocrine disorders, hematologic disorders, nutritional deficiencies, and/or drugs);
5. Serum corrected calcium > 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 < 40.0 IU/L at the Screening Visit;
9. Positive results for Hepatitis B sAg, Hepatitis C antibody, Hepatitis A IgM or HIV Viral Serology tests at the Screening Visit;
10. A history of drug abuse within 12 months preceding the Screening Visit;
11. A history of alcohol abuse within 12 months preceding the Screening Visit. Alcoholism is defined as the consumption of more than 28 units of alcohol a week (an alcohol unit is defined as 300 mL of beer, 100 mL of wine, or 25 mL of hard liquor);
12. A medical history of hyperparathyroidism or hypoparathyroidism;
13. Current uncontrolled hyperthyroidism or hypothyroidism (see Appendix 2);
14. A medical history of parathyroidectomy;
15. A medical history of complete or partial thyroidectomy without original documentation that the parathyroid glands remain intact;
16. A medical history of other bone or calcium metabolic disorders (e.g., Paget’s Disease, osteomalacia, malabsorption syndrome, or severe scoliosis);
17. A medical history of type 1 diabetes, current uncontrolled type 2 diabetes (defined as hemoglobin A1c > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>• To determine the effect of JTT-305 on the changes in bone turnover markers when administered for 24 weeks to postmenopausal women with osteoporosis.<br>• 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.
- Secondary Outcome Measures
Name Time Method