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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01406548
First received: July 11, 2011
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Osteopenia
Osteoporosis
Drug: BPS804
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • The number (percent) of subjects experiencing adverse events or serious adverse events [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline during 9 months of serological bone biomarkers for the individual BPS804 groups and pooled placebo arms. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Characterization of the PK profile of BPS804: area under the plasma concentration-time curve (AUC) [ Time Frame: 260 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Characterization of the PK profile: time to reach the maximum concentration (Tmax) [ Time Frame: 260 days ] [ Designated as safety issue: No ]
  • Characterization of the PK profile of BPS804: half-life (T1/2) [ Time Frame: 260 days ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: July 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406548

Locations
United States, California
Novartis Investigative Site
Anaheim, California, United States, 92801-2811
United States, Florida
Novartis Investigative Site
Miami, Florida, United States, 33175
Novartis Investigative Site
Miami, Florida, United States, 33126
United States, New Jersey
Novartis Investigative Site
Berlin, New Jersey, United States, 08009
United States, Pennsylvania
Novartis Investigative Site
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01406548     History of Changes
Other Study ID Numbers: CBPS804A2203
Study First Received: July 11, 2011
Last Updated: September 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Osteopenia
osteoporosis
low bone mineral density

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 01, 2014