BA058 Transdermal Phase 2 Study in Women with Osteoporosis
- Conditions
- Osteoporosis in postmenopausal womenMedDRA version: 14.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2012-001921-29-DK
- Lead Sponsor
- Radius Health Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 240
• 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).
- 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
• 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 four weeks prior.
• 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.
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 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.<br>• Determine the effects of six months of treatment with BA058 Transdermal on hip and forearm BMD when compared with placebo.<br>• Determine the effects of six months of treatment with BA058 Transdermal on serum markers of bone formation and resorption when compared with placebo.<br>• Determine the safety and tolerability of six months of dosing with BA058 Transdermal. <br>• Select a dose level of BA058 Transdermal for further clinical evaluation.<br>;Primary end point(s): Change in BMD;Timepoint(s) of evaluation of this end point: 6 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Changes in levels of PINP, PICP, BSAP, osteocalcin and CTXI<br>• 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<br>• Optimal Dose Selection;Timepoint(s) of evaluation of this end point: 6 months