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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01406548

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

8.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteopenia Osteoporosis	Drug: BPS804 Drug: Placebo Drug: BPS804 Drug: Placebo Drug: BPS804 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BPS804 dosing frequency 1	Drug: BPS804
Placebo Comparator: placebo dosing frequency 1	Drug: Placebo
Experimental: BPS804 dosing frequency 2	Drug: BPS804
Placebo Comparator: placebo dosing frequency 2	Drug: Placebo
Experimental: BPS804 dosing frequency 3	Drug: BPS804
Placebo Comparator: Placebo dosing frequency 3	Drug: Placebo

Outcome Measures

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. [9 months]
The number (percent) of subjects experiencing adverse events or serious adverse events [9 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Novartis Investigative Site	Duncansville	Pennsylvania	United States	16635