Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
Radius Health, Inc.
ClinicalTrials.gov Identifier:
NCT00542425
First received: October 10, 2007
Last updated: June 30, 2010
Last verified: June 2010
Results First Received: June 30, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: teriparatide
Drug: Placebo
Drug: BA058 20 µg
Drug: BA058 40 µg
Drug: BA058 80 µg

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment for the study started in the US, in January 2007. For the initial 24-week treatment period, patients were randomized to study treatment at 30 study centers in the US, Argentina, India and the UK . Eleven of the 30 study centers treated patients in the 24-week treatment extension period in the US, Argentina, and India.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After eligibility was established, patients entered a 4-week Pretreatment Period during which they received daily Calcium and Vitamin D supplements, were trained in self-injection with the pen devices, and were assessed for additional evaluations at the end of the Pretreatment Period. Patients who remained eligible were randomized on Day 1.

Reporting Groups
  Description
Placebo No text entered.
BA058 20 µg No text entered.
BA058 40 µg No text entered.
BA058 80 µg No text entered.
Teriparatide No text entered.

Participant Flow for 2 periods

Period 1:   Initial 24 Weeks
    Placebo     BA058 20 µg     BA058 40 µg     BA058 80 µg     Teriparatide  
STARTED     46     43     43     45     45  
COMPLETED     42     33     36     34     39  
NOT COMPLETED     4     10     7     11     6  
Administrative reasons                 0                 0                 1                 1                 0  
Adverse Event                 0                 1                 1                 3                 2  
Inability to complete procedures                 0                 3                 2                 1                 2  
Lost to Follow-up                 2                 2                 1                 0                 0  
Non-compliance                 0                 0                 0                 1                 1  
Protocol Violation                 0                 0                 0                 1                 0  
Refusal of treatment                 2                 2                 1                 4                 1  
Other                 0                 2                 1                 0                 0  

Period 2:   Extended 24 Weeks of Treatment
    Placebo     BA058 20 µg     BA058 40 µg     BA058 80 µg     Teriparatide  
STARTED     11 [1]   13 [1]   10 [1]   7 [1]   14 [1]
COMPLETED     10     11     8     6     13  
NOT COMPLETED     1     2     2     1     1  
Adverse Event                 0                 0                 1                 1                 0  
Protocol Violation                 0                 0                 1                 0                 0  
Refusal of treatment                 0                 1                 0                 0                 0  
Other                 1                 1                 0                 0                 1  
[1] Not all patients were eligible for extension study, often due to the regulatory approval timeline.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo No text entered.
BA058 20 µg No text entered.
BA058 40 µg No text entered.
BA058 80 µg No text entered.
Teriparatide No text entered.
Total Total of all reporting groups

Baseline Measures
    Placebo     BA058 20 µg     BA058 40 µg     BA058 80 µg     Teriparatide     Total  
Number of Participants  
[units: participants]
  46     43     43     45     45     222  
Age  
[units: years]
Mean ± Standard Deviation
  65  ± 7.11     66.3  ± 6.96     64.5  ± 7.35     64.8  ± 7.21     64.5  ± 7.48     65  ± 7.19  
Gender  
[units: participants]
           
Female     46     43     43     45     45     222  
Male     0     0     0     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Marker of Bone Metabolism, PINP   [ Time Frame: 6 months ]

2.  Primary:   Change in Bone Mineral Density, Total Spine.   [ Time Frame: 6 months ]

3.  Secondary:   Change in Bone Mineral Density, Femoral Neck.   [ Time Frame: 6 months ]

4.  Secondary:   Change in Bone Mineral Density, Total Hip.   [ Time Frame: 6 months ]

5.  Secondary:   Change in Bone Mineral Density, Total Spine.   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Program Director
Organization: Radius Health, Inc.
phone: (617) 551-4700
e-mail: info@radiuspharm.com


No publications provided


Responsible Party: Program Director, Radius Health, Inc.
ClinicalTrials.gov Identifier: NCT00542425     History of Changes
Other Study ID Numbers: BA058-05-002
Study First Received: October 10, 2007
Results First Received: June 30, 2010
Last Updated: June 30, 2010
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
India: Ministry of Health