Osteoporosis in postmenopausal women MedDRA version: 16.0 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: BA058 Coated Solid Microstructured Transdermal System
Product Code: BA058 sMTS
Pharmaceutical Form: Transdermal system
INN or Proposed INN: BA058
Current Sponsor code: BA058 sMTS
Concent
Sponsors
Radius Health Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The subject is a healthy ambulatory postmenopausal woman not older than 85 years of age with osteoporosis. • Subject has been postmenopausal for at least 5 years. • Subject has a BMD T-score = 2.5 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA). Correct to BMD T-score = 2.5. - Subjects may also be included if they have a BMD T-score of = 2.0 and a prior low-trauma forearm, humerus, vertebral, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years - or who have an additional risk factor such as age 65 to 85 , or a strong maternal history of osteoporosis. • Is in good general health as determined by medical history and physical examination (including vital signs) • The subject has serum calcium (albumin-corrected), PTH (1-84), serum phosphorus and alkaline phosphatase values all within the normal range during the Screening Period. • Has a serum 25-hydroxy vitamin D value >15 ng/mL (37.4 nmol/L) and within 3 times the upper normal range. • Subject’s resting 12-lead electrocardiogram shows no clinically significant abnormality and a QTc =470°msec (Bazett’s correction). • Subject’s systolic blood pressure is =100 and =155 mmHg, diastolic blood pressure is =40 and =95 mmHg, and heart rate is =45 and =100 bpm (sitting or supine). • Subject has no clinically significant abnormality of serum hemoglobin, hematocrit, WBC and platelets, or serum biochemistry: electrolytes, renal function, liver function and serum proteins. • Subject has signed the written informed consent form. 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: • The subject has a BMD T-score = - 0.5 at the lumbare spine or hip • Abnormalities of the lumbar spine that would prohibit assessment of spinal BMD. • Unevaluable hip BMD or have undergone bilateral hip replacement • History of bone disorders (e.g., Paget’s disease). • Chronic radiation therapy other than radioiodine. • History of chronic or recurrent disease or medical condition that would interfere with the interpretation of study data or compromise the safety of the subject. • Significantly impaired renal function (serum creatinine >177 µmol/L or >2.0 mg/dL). • History of any cancer within the past 5 years. • History of osteosarcoma. • History of nephrolithiasis or urolithiasis within the past 5 years. • Decrease of 20 mmHg or more in systolic blood pressure or 10 mmHg or more in diastolic blood pressure from supine to standing and/or any symptomatic hypotension at screening • Positive for Hepatitis B, Hepatitis C, HIV-1 or HIV-2. • Known hypersensitivity to any of the test materials or related compounds. • Prior treatment with PTH or PTHrP drugs. • Prior treatment with bisphosphonates or strontium in the past five years, or prior treatment with gallium nitrate, or with a bone-acting investigational agent at any time. • Prior treatment with denosumab, calcitonin, SERMs, tibolone, or anabolic steroids in the past 12 months. • Treatments with anticonvulsants that affect vitamin D metabolism or with heparin within the 6 months prior. • Daily treatment with oral, intranasal or inhaled corticosteroids above the equivalent of 5 mg oral cortisone per day within the 12 months prior. • Exposure to general anesthesia within the 4 weeks prior to the Screening Period. • Exposure to an investigational drug within the 12 months prior. • Abnormal nutritional status, vitamin D intake of =4,000 IU/day or vitamin A intake of =10,000 IU/day. • Known to abuse alcohol or use illegal drugs within 12 months prior.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the clinical safety and efficacy of BA058 Transdermal in otherwise healthy postmenopausal women with osteoporosis.;Secondary Objective: • Determine the effects of six months of treatment with BA058 Transdermal on lumbar spine BMD when compared with placebo. • Determine the effects of six months of treatment with BA058 Transdermal on hip and forearm BMD when compared with placebo. • Determine the effects of six months of treatment with BA058 Transdermal on serum markers of bone formation and resorption when compared with placebo. • Determine the safety and tolerability of six months of dosing with BA058 Transdermal. • Select a dose level of BA058 Transdermal for further clinical evaluation. ;Primary end point(s): Change in BMD;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Changes in levels of PINP, PICP, BSAP, osteocalcin, CTXI • Safety analyses will include the incidence and severity of adverse events by treatment, dose and cumulative dose and pathological changes in hematology, chemistry and urinalysis data • Optimal Dose Selection;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Czech Republic, Denmark, Estonia, Hong Kong, Lithuania, Poland, Romania, United States
Contacts
Public ContactMedical Officer
Radius Health Inc.
Outcome results
None listed