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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406548
• Other study ID #: CBPS804A2203
• Status: Completed
• Phase: Phase 2
• Start date: July 2011
• Est. completion date: October 2013

Study information

• Verified date: September 2022
• Source: Ultragenyx Pharmaceutical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study was conducted and previously posted by Novartis. The record was transferred to Ultragenyx in February 2021.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia
• Osteoporosis

Intervention

Drug:
• BPS804 20mg/Kg

• Placebo to 20mg/Kg BPS804

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Anaheim	California
United States	Novartis Investigative Site	Berlin	New Jersey
United States	Novartis Investigative Site	Duncansville	Pennsylvania
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Ultragenyx Pharmaceutical Inc	Mereo BioPharma, Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to month 9 in bone mineral density at the lumbar spine for the individual BPS804 groups and pooled placebo arms.		9 months
Primary	The number (percent) of subjects experiencing adverse events or serious adverse events		9 months
Secondary	Change from baseline during 9 months of serological bone biomarkers for the individual BPS804 groups and pooled placebo arms.		9 months
Secondary	Characterization of the PK profile of BPS804: area under the plasma concentration-time curve (AUC)		260 days
Secondary	Characterization of the PK profile of BPS804: time to reach the maximum Characterization of the PK profile of BPS804: maximum plasma concentration (Cmax)		260 days
Secondary	Characterization of the PK profile: time to reach the maximum concentration (Tmax)		260 days
Secondary	Characterization of the PK profile of BPS804: half-life (T1/2)		260 days