Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density

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