Back to resultsSafety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density
Primary Purpose
Osteopenia, Osteoporosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BPS804 20mg/Kg
Placebo to 20mg/Kg BPS804
Sponsored by
About this trial
This is an interventional treatment trial for Osteopenia focused on measuring Osteopenia, osteoporosis, low bone mineral density
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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
BPS804 dosing frequency 1
placebo dosing frequency 1
BPS804 dosing frequency 2
placebo dosing frequency 2
BPS804 dosing frequency 3
Placebo dosing frequency 3
Arm Description
Subjects dosed 20mg/Kg BPS804 monthly
Subjects dosed with matching placebo to 20mg/Kg BPS804 monthly
Subjects dosed with 20mg/Kg BPS804 quarterly
Subjects dosed with matching placebo to 20mg/Kg BPS804 every 3 months
Subjects dosed with 20mg/Kg BPS804 weekly
Subjects dosed with matching placebo to 20mg/Kg BPS804 weekly
Outcomes
Primary Outcome Measures
Change from baseline to month 9 in bone mineral density at the lumbar spine for the individual BPS804 groups and pooled placebo arms.
The number (percent) of subjects experiencing adverse events or serious adverse events
Secondary Outcome Measures
Change from baseline during 9 months of serological bone biomarkers for the individual BPS804 groups and pooled placebo arms.
Characterization of the PK profile of BPS804: area under the plasma concentration-time curve (AUC)
Characterization of the PK profile of BPS804: time to reach the maximum Characterization of the PK profile of BPS804: maximum plasma concentration (Cmax)
Characterization of the PK profile: time to reach the maximum concentration (Tmax)
Characterization of the PK profile of BPS804: half-life (T1/2)
Full Information
NCT ID
NCT01406548
First Posted
July 11, 2011
Last Updated
September 9, 2022
Sponsor
Ultragenyx Pharmaceutical Inc
Collaborators
Mereo BioPharma, Novartis
1. Study Identification
Unique Protocol Identification Number
NCT01406548
Brief Title
Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ultragenyx Pharmaceutical Inc
Collaborators
Mereo BioPharma, Novartis
4. Oversight
5. Study Description
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 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.
Detailed Description
This study was conducted and previously posted by Novartis. The record was transferred to Ultragenyx in February 2021.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia, Osteoporosis
Keywords
Osteopenia, osteoporosis, low bone mineral density
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BPS804 dosing frequency 1
Arm Type
Experimental
Arm Description
Subjects dosed 20mg/Kg BPS804 monthly
Arm Title
placebo dosing frequency 1
Arm Type
Placebo Comparator
Arm Description
Subjects dosed with matching placebo to 20mg/Kg BPS804 monthly
Arm Title
BPS804 dosing frequency 2
Arm Type
Experimental
Arm Description
Subjects dosed with 20mg/Kg BPS804 quarterly
Arm Title
placebo dosing frequency 2
Arm Type
Placebo Comparator
Arm Description
Subjects dosed with matching placebo to 20mg/Kg BPS804 every 3 months
Arm Title
BPS804 dosing frequency 3
Arm Type
Experimental
Arm Description
Subjects dosed with 20mg/Kg BPS804 weekly
Arm Title
Placebo dosing frequency 3
Arm Type
Placebo Comparator
Arm Description
Subjects dosed with matching placebo to 20mg/Kg BPS804 weekly
Intervention Type
Drug
Intervention Name(s)
BPS804 20mg/Kg
Intervention Type
Drug
Intervention Name(s)
Placebo to 20mg/Kg BPS804
Primary Outcome Measure Information:
Title
Change from baseline to month 9 in bone mineral density at the lumbar spine for the individual BPS804 groups and pooled placebo arms.
Time Frame
9 months
Title
The number (percent) of subjects experiencing adverse events or serious adverse events
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Change from baseline during 9 months of serological bone biomarkers for the individual BPS804 groups and pooled placebo arms.
Time Frame
9 months
Title
Characterization of the PK profile of BPS804: area under the plasma concentration-time curve (AUC)
Time Frame
260 days
Title
Characterization of the PK profile of BPS804: time to reach the maximum Characterization of the PK profile of BPS804: maximum plasma concentration (Cmax)
Time Frame
260 days
Title
Characterization of the PK profile: time to reach the maximum concentration (Tmax)
Time Frame
260 days
Title
Characterization of the PK profile of BPS804: half-life (T1/2)
Time Frame
260 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Ultragenyx Pharmaceutical Inc
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801-2811
Country
United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Novartis Investigative Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Novartis Investigative Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density
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