A Randomized, Parallel-Group, Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women with Osteoporosis
- Conditions
- Osteoporosis in postmenopausal women.MedDRA version: 9.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausal
- Registration Number
- EUCTR2007-004779-21-GB
- Lead Sponsor
- Radius Health, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
1.The patient is a healthy ambulatory postmenopausal woman from 55 to 85 years of age (inclusive) with osteoporosis. Postmenopausal women younger than 55 years of age with known osteoporosis who meet all other entry criteria also may be considered for enrollment.
2.The patient has been postmenopausal for at least 5 years. Postmenopausal status will be established by a history of amenorrhea for at least 5 years and by an elevated serum follicle-stimulating hormone (FSH) value based on the postmenopausal range of the assay.
3.The patient has a bone mineral density T-score = 2.5 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA). Women with a bone mineral density T-score of 2.0 or lower 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 or greater or a strong maternal history of osteoporosis defined as a fracture related to osteoporosis or osteoporosis itself as determined by BMD criteria, are also study candidates.
4.The patient is in good general health as determined by medical history and physical examination (including vital signs), has a body mass index (BMI) of 18.5 to 33, inclusive, and is without evidence of clinically significant abnormality in the opinion of the Investigator (refer to Appendix 14.3).
5.Any required concomitant medications which are not excluded in Section 6.0 may be continued through the study. Every effort should be made to maintain the medication at a stable dose throughout the study, subject to the Investigator’s medical judgment.
6.The patient has serum total calcium, PTH(1-84), serum 25-hydroxy Vitamin D, serum phosphorus, and alkaline phosphatase values all within the normal range during the Screening Period.
7.The patient’s resting 12-lead electrocardiogram obtained during screening shows no clinically significant abnormality and a QTc = 470 msec (Bazett’s correction).
8.The patient’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.
9.The patient has no clinically significant abnormality of serum hemoglobin, hematocrit, WBC and platelets, or usual serum biochemistry: electrolytes, renal function, liver function and serum proteins.
10.The patient has read, understood, and 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
General exclusion criteria:
1.History of bone disorders (e.g., Paget’s disease) other than postmenopausal osteoporosis.
2.Unexplained elevation of serum alkaline phosphatase.
3.History of radiotherapy (radiation therapy).
4.History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances to a degree that would interfere with the interpretation of study data or compromise the safety of the patient.
5.History of malabsorption or of significantly impaired renal function (serum creatinine >177 µmol/L or 1.5 mg/dL).
6.History of carcinoma, nephrolithiasis or urolithiasis within the past five years or osteosarcoma at any time.
7.Vitamin D deficiency, defined as a serum 25-hydroxy Vitamin D level of < 15 ng/mL. Patients with a normal serum 25-hydroxy Vitamin D level but less than 15 ng/mL may be considered for enrollment on a case by case basis.
8.Decrease of 20 mmHg or more in systolic blood pressure or 10 mmHg or more in diastolic blood pressure from supine to standing (5 minutes lying and 3 minutes standing) and/or any symptomatic hypotension (21,22).
9.Patients known to be positive for Hepatitis B, Hepatitis C, HIV-1 or HIV-2. Testing is not required in the absence of clinical signs and symptoms suggestive of HIV infection or acute or chronic hepatitis.
10.Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal bone mineral density, defined as having at least 2 radiologically evaluable vertebrae within L1-4.
11.Patients who have undergone bilateral hip replacement (unilateral hip replacement is acceptable).
12.Previously randomized and dosed in this study; patients cannot be entered into the study a second time.
Medication related exclusion criteria:
13.Known history of hypersensitivity to any of the test materials or related compounds.
14.Prior treatment with bisphosphonates or strontium in the past five years, or prior treatment with parathyroid hormone or its analogs, with fluoride, or with gallium nitrate, or with as yet unapproved bone-acting investigational agents such as denosumab at any time (23).
15.Prior treatment with calcitonin, estrogens, estrogen derivatives, SERMs (such as raloxifene or tamoxifen), tibolone, progestins or anabolic steroids in the past 6 months or current treatment with thiazide diuretics.
16.Daily treatment with oral, intranasal or inhaled corticosteroids within the 6 months prior to the Screening Period.
17.Exposure to general anesthesia within the 12 weeks prior to the Screening Period.
18.Exposure to an investigational drug within the 12 months prior to the Screening Period.
Lifestyle related exclusion criteria:
19.Abnormal nutritional status (abnormal diets, excessive or unusual vitamin or herbal intakes, malabsorption, significant recent weight change), Vitamin D intake of = 1200 IU/day or Vitamin A intake of = 10,000 IU/day.
20.Patient is known to abuse alcohol or use illegal drugs within 12 months of the Screening Period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method