Status:
COMPLETED
Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density
Lead Sponsor:
Ultragenyx Pharmaceutical Inc
Collaborating Sponsors:
Mereo BioPharma
Novartis
Conditions:
Osteopenia
Osteoporosis
Eligibility:
FEMALE
45-85 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
This study was conducted and previously posted by Novartis. The record was transferred to Ultragenyx in February 2021.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01406548
Start Date
July 1 2011
End Date
October 1 2013
Last Update
September 15 2022
Active Locations (5)
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1
Novartis Investigative Site
Anaheim, California, United States, 92801-2811
2
Novartis Investigative Site
Miami, Florida, United States, 33126
3
Novartis Investigative Site
Miami, Florida, United States, 33175
4
Novartis Investigative Site
Berlin, New Jersey, United States, 08009