Adherence to PTH(1-84) Treatment (FP-002-IM)

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

  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
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

  Show Serious Adverse Events

  Other Adverse Events

  Show Other Adverse Events

  Limitations and Caveats

  Hide 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

  Hide More Information

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: 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. 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. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: Any study related publication will be multi-center or single-center publications. All proposed site publications and presentations will be submitted to (sponsor) NPS Pharmaceuticals for review in advance of publication.

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
First Submitted:	May 23, 2007
First Posted:	May 25, 2007
Results First Submitted:	April 29, 2014
Results First Posted:	May 28, 2014
Last Update Posted:	May 28, 2014