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Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benjamin Leder, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01750086
First received: November 26, 2012
Last updated: February 22, 2017
Last verified: February 2017
Results First Received: November 30, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Postmenopausal Osteoporosis
Interventions: Drug: Teriparatide 40-mcg subcutaneous injection
Drug: Denosumab Injection
Drug: Alendronate Oral Tablet

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Denosumab 60mg Subcutaneous Injection

Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.

Teriparatide 40-mcg subcutaneous injection

Alendronate 70mg Weekly x 8 Weeks

Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.

Teriparatide 40-mcg subcutaneous injection


Participant Flow:   Overall Study
    Denosumab 60mg Subcutaneous Injection   Alendronate 70mg Weekly x 8 Weeks
STARTED   13   14 
COMPLETED   12   13 
NOT COMPLETED   1   1 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Denosumab 60mg Subcutaneous Injection

Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.

Teriparatide 40-mcg subcutaneous injection

Alendronate 70mg Weekly x 8 Weeks

Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.

Teriparatide 40-mcg subcutaneous injection

Total Total of all reporting groups

Baseline Measures
   Denosumab 60mg Subcutaneous Injection   Alendronate 70mg Weekly x 8 Weeks   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   13   25 
Age 
[Units: Years]
Mean (Standard Deviation)
 66  (7)   66  (8)   66  (8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      12 100.0%      13 100.0%      25 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   12   13   25 


  Outcome Measures

1.  Primary:   Bone Turnover Marker (Blood Sample)   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Joy Tsai
Organization: Massachusetts General Hospital
phone: 617-726-6723
e-mail: jntsai@mgh.harvard.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Benjamin Leder, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01750086     History of Changes
Other Study ID Numbers: 2012P001956
Study First Received: November 26, 2012
Results First Received: November 30, 2016
Last Updated: February 22, 2017