Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 11, 2011
September 23, 2014
July 2011
October 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01406548 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteopenia
  • Osteoporosis
  • Drug: BPS804
  • Drug: Placebo
  • Experimental: BPS804 dosing frequency 1
    Intervention: Drug: BPS804
  • Placebo Comparator: placebo dosing frequency 1
    Intervention: Drug: Placebo
  • Experimental: BPS804 dosing frequency 2
    Intervention: Drug: BPS804
  • Placebo Comparator: placebo dosing frequency 2
    Intervention: Drug: Placebo
  • Experimental: BPS804 dosing frequency 3
    Intervention: Drug: BPS804
  • Placebo Comparator: Placebo dosing frequency 3
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
October 2013
October 2013   (final data collection date for primary outcome measure)

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

Female
45 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01406548
CBPS804A2203
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP