Clinical trial: Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density (NCT01406548)

Eligibility criteria:
Inclusion Criteria:

          -  Postmenopausal women (natural or surgically induced menopause)

          -  Low bone mineral density (BMD), as defined by a T score or equivalent BMD absolute
             value (g/cm2) for lumbar spine of between -2.0 and -3.5, inclusive

          -  Body mass index (BMI) must be within the range of 18 to 35kg/m2. Subjects must weigh
             between 45 and 120kg inclusive to participate.

          -  25-(OH) vitamin D serum level of ≥ 15ng/ml

          -  Serum calcium within normal limits

        Exclusion Criteria:

          -  Subjects with suspected neural foraminal stenosis (e.g., cervical, spinal, lumbar), or
             history of Bell's palsy, cranial nerve disorders, temporomandibular joint and muscle
             disorders.

          -  Subjects who have an increased baseline risk of osteosarcoma: Paget's disease of the
             bone or unexplained and clinically significant elevations of alkaline phosphatase
             and/or subjects who have received radiation therapy involving the skeleton.

          -  Subjects with any known bone diseases other than postmenopausal osteoporosis.

          -  Subjects with a history of an osteoporotic fracture (e.g., vertebral fracture,
             fragility fracture of the wrist, radius, humerus, hip, or pelvis).

          -  Subjects who are regularly using or have regularly used agents affecting bone
             metabolism:

               -  Calcitonin, estrogen, SERMs (raloxifene, Tamoxifen, etc.), Tibolone progestin, or
                  androgens within the last three (3) months prior to screening.

               -  Any oral bisphosphonate, lithium chloride, fluoride or systemic
                  glucocorticosteroids (p.o. or i.v.) where the total dose exceeds 750 mg of
                  prednisone or equivalent within the last year prior to screening.

               -  Any previous use of denusomab (ProliaTM), parathyroid hormone (ForteoTM), and/or
                  PTH analogs, strontium ranelate, or parenteral formulations of bisphosphonates.

          -  Current disease(s) known to influence calcium metabolism including
             hyperparathyroidism, hypoparathyroidism, hypocalcemia or hypercalcemia.

          -  Any disease, abnormality or deformation of the spine (e.g., scoliosis, ankylosing
             spondylitis, osteophytes) or hip (e.g., joint prosthesis) which would preclude the
             proper acquisition of a lumbar spine DXA (L1-L4) or femur DXA, respectively.

        Other protocol-defined inclusion/exclusion criteria may apply
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Contradiction