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



Status:Completed
Conditions:Osteoporosis, Gastrointestinal
Therapuetic Areas:Gastroenterology, Rheumatology
Healthy:No
Age Range:45 - 85
Updated:5/5/2014
Start Date:July 2011
End Date:January 2014
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Assess the Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density

This study is designed to provide information on the safety, tolerability, pharmacokinetics
(PK) and bone biomarker response following multiple BPS804 administration in multiple dosing
regimens. This information will permit a comparison of the possible risks and benefits of
different dosing regimens of the study drug to enable optimal doses and dose intervals to be
tested in subsequent studies.


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
We found this trial at
6
sites
Anaheim, California 92801
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Berlin, New Jersey 08009
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Duncansville, Pennsylvania 16635
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Kalamazoo, Michigan 49048
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Miami, Florida 33136
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Miami, Florida 33136
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Miami, FL
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