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Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis (DATA)

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ClinicalTrials.gov Identifier: NCT00926380
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Benjamin Leder, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: denosumab
Drug: teriparatide

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Denosumab ONLY denosumab: denosumab: 60 mg SC every 6 months
Teriparatide (Forteo®) ONLY teriparatide: teriparatide: 20 mcg SC QD
Denosumab and Teriparatide (Forteo®)

denosumab: denosumab: 60 mg SC every 6 months

teriparatide: teriparatide: 20 mcg SC QD


Participant Flow for 2 periods

Period 1:   Year 1
    Denosumab ONLY   Teriparatide (Forteo®) ONLY   Denosumab and Teriparatide (Forteo®)
STARTED   33   31   30 
COMPLETED   33   30   29 
NOT COMPLETED   0   1   1 

Period 2:   Year 2
    Denosumab ONLY   Teriparatide (Forteo®) ONLY   Denosumab and Teriparatide (Forteo®)
STARTED   33   30   29 
COMPLETED   31   28   24 
NOT COMPLETED   2   2   5 



  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
Denosumab ONLY denosumab: denosumab: 60 mg SC every 6 months
Teriparatide (Forteo®) ONLY teriparatide: teriparatide: 20 mcg SC QD
Denosumab and Teriparatide (Forteo®)

denosumab: denosumab: 60 mg SC every 6 months

teriparatide: teriparatide: 20 mcg SC QD

Total Total of all reporting groups

Baseline Measures
   Denosumab ONLY   Teriparatide (Forteo®) ONLY   Denosumab and Teriparatide (Forteo®)   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   31   30   94 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.3  (8.3)   65.5  (7.9)   65.9  (9.0)   65.9  (8.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      33 100.0%      31 100.0%      30 100.0%      94 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      1   3.0%      0   0.0%      1   3.3%      2   2.1% 
Not Hispanic or Latino      32  97.0%      31 100.0%      29  96.7%      92  97.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1   3.0%      0   0.0%      0   0.0%      1   1.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   3.0%      0   0.0%      2   6.7%      3   3.2% 
White      31  93.9%      31 100.0%      28  93.3%      90  95.7% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   33   31   30   94 
Body-mass index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 24.1  (3.9)   25.5  (3.8)   25.4  (4.9)   25.0  (4.2) 
History of fragility fracture 
[Units: Participants]
Count of Participants
 12   16   10   38 
Previous oral bisphosphonate use 
[Units: Participants]
Count of Participants
 12   13   10   35 
25-Hydroxyvitamin D (ng/mL) 
[Units: ng/mL]
Mean (Standard Deviation)
 35.3  (10.5)   31.2  (8.5)   33.9  (11.8)   33.5  (10.5) 
Alkaline phosphatase concentration in serum (U/L) 
[Units: U/L]
Mean (Standard Deviation)
 78.8  (16.8)   75.8  (16.8)   84.2  (20.8)   79.6  (18.4) 
Osteocalcin (ng/mL) 
[Units: ng/mL]
Mean (Standard Deviation)
 42.9  (19.4)   49.0  (28.8)   52.2  (29.9)   47.8  (26.2) 
Serum amino-terminal propeptide of type 1 procollagen (P1NP) (µg/L) 
[Units: µg/L]
Mean (Standard Deviation)
 45.7  (16.7)   46.0  (19.5)   49.3  (20.9)   47.1  (19.0) 
Serum β-C-terminal telopeptide of type 1 collagen (CTX) (ng/mL) 
[Units: ng/mL]
Mean (Standard Deviation)
 0.39  (0.21)   0.36  (0.15)   0.43  (0.17)   0.39  (0.18) 
DXA Bone Density (g/cm^2) (Posterior-anterior lumbar spine) 
[Units: G/cm^2]
Mean (Standard Deviation)
 0.866  (0.088)   0.823  (0.111)   0.856  (0.131)   0.848  (0.112) 
DXA Bone Density (g/cm^2) (Femoral neck) 
[Units: G/cm^2]
Mean (Standard Deviation)
 0.641  (0.086)   0.643  (0.061)   0.642  (0.067)   0.642  (0.071) 
DXA Bone Density (g/cm^2) (Total hip) 
[Units: G/cm^2]
Mean (Standard Deviation)
 0.766  (0.100)   0.757  (0.068)   0.759  (0.073)   0.761  (0.081) 
DXA Bone Density (g/cm^2) (Distal 1/3 of the radius shaft) 
[Units: G/cm^2]
Mean (Standard Deviation)
 0.602  (0.082)   0.612  (0.069)   0.613  (0.070)   0.609  (0.073) 


  Outcome Measures

1.  Primary:   Change in Spine Bone Density From Baseline to 2 Years   [ Time Frame: Two years ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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: Natalie David
Organization: Massachusetts General Hospital
e-mail: ndavid2@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: NCT00926380     History of Changes
Other Study ID Numbers: 20080723
2009P000525
First Submitted: June 19, 2009
First Posted: June 23, 2009
Results First Submitted: March 8, 2018
Results First Posted: May 8, 2018
Last Update Posted: May 8, 2018