Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Postmenopausal Women With Low Bone Mineral Density
This study is currently recruiting participants.
Verified September 2012 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01406548
First received: July 11, 2011
Last updated: September 10, 2012
Last verified: September 2012
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | July 11, 2011 | ||||
Last Updated Date | September 10, 2012 | ||||
Start Date ICMJE | July 2011 | ||||
Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01406548 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Postmenopausal Women With Low Bone Mineral Density | ||||
Official Title ICMJE | A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Assess the Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Postmenopausal Women With Low Bone Mineral Density | ||||
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. |
||||
Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||
Condition ICMJE |
|
||||
Intervention ICMJE |
|
||||
Study Arm (s) |
|
||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 75 | ||||
Estimated Completion Date | September 2013 | ||||
Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply |
||||
Gender | Female | ||||
Ages | 45 Years to 85 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
|
||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01406548 | ||||
Other Study ID Numbers ICMJE | CBPS804A2203 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||
Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
|
||||
Information Provided By | Novartis | ||||
Verification Date | September 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |