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

NCT01406548 | Completed Phase 2

• 1 other identifier: CBPS804A2203
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 5

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.

Conditions

Osteopenia; Osteoporosis

Keywords

Osteopenia; osteoporosis; low bone mineral density

Outcome Measures

Primary Outcomes (2)

• 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

• The number (percent) of subjects experiencing adverse events or serious adverse events

  9 months

Secondary Outcomes (5)

• Change from baseline during 9 months of serological bone biomarkers for the individual BPS804 groups and pooled placebo arms.

  9 months

• Characterization of the PK profile of BPS804: area under the plasma concentration-time curve (AUC)

  260 days

• 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

• Characterization of the PK profile: time to reach the maximum concentration (Tmax)

  260 days

• Characterization of the PK profile of BPS804: half-life (T1/2)

  260 days

Study Arms (6)

BPS804 dosing frequency 1

EXPERIMENTAL

Subjects dosed 20mg/Kg BPS804 monthly

Drug: BPS804 20mg/Kg

placebo dosing frequency 1

PLACEBO COMPARATOR

Subjects dosed with matching placebo to 20mg/Kg BPS804 monthly

Drug: Placebo to 20mg/Kg BPS804

BPS804 dosing frequency 2

EXPERIMENTAL

Subjects dosed with 20mg/Kg BPS804 quarterly

Drug: BPS804 20mg/Kg

placebo dosing frequency 2

PLACEBO COMPARATOR

Subjects dosed with matching placebo to 20mg/Kg BPS804 every 3 months

Drug: Placebo to 20mg/Kg BPS804

BPS804 dosing frequency 3

EXPERIMENTAL

Subjects dosed with 20mg/Kg BPS804 weekly

Drug: BPS804 20mg/Kg

Placebo dosing frequency 3

PLACEBO COMPARATOR

Subjects dosed with matching placebo to 20mg/Kg BPS804 weekly

Drug: Placebo to 20mg/Kg BPS804

Interventions

BPS804 20mg/Kg DRUG

BPS804 dosing frequency 1; BPS804 dosing frequency 2; BPS804 dosing frequency 3

Placebo to 20mg/Kg BPS804 DRUG

Placebo dosing frequency 3; placebo dosing frequency 1; placebo dosing frequency 2

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• (OH) vitamin D serum level of ≥ 15ng/ml
• Serum calcium within normal limits

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ultragenyx Pharmaceutical Inc: lead
• Mereo BioPharma: collaborator
• Novartis: collaborator

Study Sites (5)

Novartis Investigative Site

Anaheim, California, 92801-2811, United States

Location

Novartis Investigative Site

Miami, Florida, 33126, United States

Location

Novartis Investigative Site

Miami, Florida, 33175, United States

Location

Novartis Investigative Site

Berlin, New Jersey, 08009, United States

Location

Novartis Investigative Site

Duncansville, Pennsylvania, 16635, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Interventions

setrusumab

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Medical Director

  Ultragenyx Pharmaceutical Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: August 1, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

US (5)