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Trial record 1 of 1 for:    FP-002-IM
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Adherence to PTH(1-84) Treatment (FP-002-IM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00478569
First received: May 23, 2007
Last updated: April 29, 2014
Last verified: April 2014
History of Changes
Results First Received: April 29, 2014  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Clinical Use of PTH(1-84)
Intervention: Drug: Parathyroid Hormone (PTH) (1-84)

  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
Participants took part in the study at 120 investigative sites in Austria, Denmark, Germany, Greece, Ireland, the Netherlands, Spain, and the United Kingdom from 1 April 2007 to 6 March 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a diagnosis of osteoporosis and prescribed parathyroid hormone (PTH)(1-84) in a normal clinical setting were enrolled in this non-interventional study for 24 months observation. 1179 participants were enrolled however for 9 patients the data was missing.

Reporting Groups
  Description
Parathyroid Hormone (PTH) (1-84) PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.

Participant Flow:   Overall Study
    Parathyroid Hormone (PTH) (1-84)
STARTED   1170 
COMPLETED   761 
NOT COMPLETED   409 



  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
Parathyroid Hormone (PTH) (1-84) PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.

Baseline Measures
   Parathyroid Hormone (PTH) (1-84) 
Overall Participants Analyzed 
[Units: Participants]
 		 1170 
Age 
[Units: Years]
Mean (Standard Deviation) 		 72.3  (9.05) 
Gender, Customized [1] 
[Units: Participants]
 		 
Male   19 
Female   1149 
Missing   2 
[1] Although the indication in the Summary of Product characteristics is only females, some males were initially enrolled in countries where the PTH treatment is reimbursed.
Race/Ethnicity, Customized 
[Units: Participants]
 		 
Caucasian   1165 
Asian   1 
African   1 
Other   1 
Missing   2 
Region of Enrollment 
[Units: Participants]
 		 
Austria   158 
Denmark   79 
Germany   246 
Greece   300 
Ireland   29 
Netherlands   65 
Spain   272 
United Kingdom   21 
Height 
[Units: Cm]
Mean (Standard Deviation) 		 156.3  (7.98) 
Weight 
[Units: Kg]
Mean (Standard Deviation) 		 63.4  (12.25) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation) 		 25.9  (4.59) 
Age at Onset of Menopause [1] 
[Units: Years]
Mean (Standard Deviation) 		 47.9  (5.49) 
[1] Total number of menopausal participants at baseline was 1148.
Age at Onset of Menopause by Category [1] 
[Units: Participants]
 		 
≤ 45 years   283 
> 45 years   749 
Missing   116 
[1] Total number of menopausal participants at baseline was 1148, respectively.
Type of Menopause [1] 
[Units: Participants]
 		 
Surgical   137 
Natural   966 
Other   25 
Missing   20 
[1] Total number of menopausal participants at baseline was 1148.
Calcium and/or Vitamin D Supplement 
[Units: Participants]
 		 
Yes   1046 
No   122 
Missing   2 
Time Since Starting PTH(1-84) 
[Units: Days]
Mean (Standard Deviation) 		 8.1  (15.52) 
PTH (1-84) Dosing Frequency 
[Units: Participants]
 		 
Once Daily   1162 
Every Other Day   6 
Missing   2 
Family History of Osteoporosis 
[Units: Participants]
 		 
Yes   223 
No   896 
Unknown   1 
Missing   50 
Alcohol Consumption 
[Units: Participants]
 		 
Never   709 
Occasionally   385 
Daily   50 
Missing   26 
Current Smoker 
[Units: Participants]
 		 
Yes   111 
No   1057 
Missing   2 
Past Smoker 
[Units: Participants]
 		 
Yes   159 
No   1009 
Missing   2 
Glucocorticosteroid Use 
[Units: Participants]
 		 
Yes   129 
No   1038 
Missing   3 
Total Hip Bone Mineral Density (BMD) [1] 
[Units: G/cm^2]
Mean (Standard Deviation) 		 0.680  (0.1239) 
[1] Measured by dual energy X-ray absorptiometry (DXA). The total number of participants for whom baseline hip BMD data was available was 654.
Total Hip T-score [1] 
[Units: Units on a scale]
Mean (Standard Deviation) 		 -2.46  (0.965) 
[1]

T-score is the bone mineral density (BMD) at the site when compared to the young normal reference mean; a healthy thirty-year-old.

Normal is a T-score of -1.0 or higher; Osteopenia is defined as between -1.0 and -2.5 Osteoporosis is defined as -2.5 or lower.

The total number of participants for whom Baseline hip T-score data was available was 812.
Spine Bone Mineral Density (BMD) [1] 
[Units: G/cm^2]
Mean (Standard Deviation) 		 0.763  (0.1480) 
[1] The total number of participants for whom baseline spine bone mineral density data was available was 738.
Spine T-score [1] 
[Units: Units on a scale]
Mean (Standard Deviation) 		 -3.10  (1.130) 
[1] The total number of participants for whom Baseline spine T-score data was available was 954.
Number of Participants With at Least One Fracture 
[Units: Participants]
 		 904 
Was Patient/relative/helper instructed in PTH(1-84) (self) injection technique? 
[Units: Participants]
 		 
Yes   1167 
No   1 
Missing   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Discontinued Before 6 Months of Treatment   [ Time Frame: 6 months ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment   [ Time Frame: From enrollment to 3, 12, 18, and 24 months ]
  Show Outcome Measure 2

3.  Secondary:   Duration of Treatment   [ Time Frame: 24 months ]
  Show Outcome Measure 3

4.  Secondary:   Treatment Compliance by Visit   [ Time Frame: From enrollment to 3, 6, 12, 18, and 24 months ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  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 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.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Takeda
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00478569     History of Changes
Other Study ID Numbers: FP-002-IM
Study First Received: May 23, 2007
Results First Received: April 29, 2014
Last Updated: April 29, 2014