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

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ClinicalTrials.gov Identifier: NCT00478569
Recruitment Status : Completed
First Posted : May 25, 2007
Results First Posted : May 28, 2014
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
Takeda

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)
Enrollment 1179

Recruitment Details 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 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.
Arm/Group Title Parathyroid Hormone (PTH) (1-84)
Hide Arm/Group Description PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
Period Title: Overall Study
Started 1170
Completed 761
Not Completed 409
Arm/Group Title Parathyroid Hormone (PTH) (1-84)
Hide Arm/Group Description PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
Overall Number of Baseline Participants 1170
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1170 participants
72.3  (9.05)
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1170 participants
Male 19
Female 1149
Missing 2
[1]
Measure Description: 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1170 participants
Caucasian 1165
Asian 1
African 1
Other 1
Missing 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1170 participants
Austria 158
Denmark 79
Germany 246
Greece 300
Ireland 29
Netherlands 65
Spain 272
United Kingdom 21
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 1170 participants
156.3  (7.98)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 1170 participants
63.4  (12.25)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 1170 participants
25.9  (4.59)
Age at Onset of Menopause   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1170 participants
47.9  (5.49)
[1]
Measure Description: Total number of menopausal participants at baseline was 1148.
Age at Onset of Menopause by Category   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1170 participants
≤ 45 years 283
> 45 years 749
Missing 116
[1]
Measure Description: Total number of menopausal participants at baseline was 1148, respectively.
Type of Menopause   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1170 participants
Surgical 137
Natural 966
Other 25
Missing 20
[1]
Measure Description: Total number of menopausal participants at baseline was 1148.
Calcium and/or Vitamin D Supplement  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1170 participants
Yes 1046
No 122
Missing 2
Time Since Starting PTH(1-84)  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 1170 participants
8.1  (15.52)
PTH (1-84) Dosing Frequency  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1170 participants
Once Daily 1162
Every Other Day 6
Missing 2
Family History of Osteoporosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1170 participants
Yes 223
No 896
Unknown 1
Missing 50
Alcohol Consumption  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1170 participants
Never 709
Occasionally 385
Daily 50
Missing 26
Current Smoker  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1170 participants
Yes 111
No 1057
Missing 2
Past Smoker  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1170 participants
Yes 159
No 1009
Missing 2
Glucocorticosteroid Use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1170 participants
Yes 129
No 1038
Missing 3
Total Hip Bone Mineral Density (BMD)   [1] 
Mean (Standard Deviation)
Unit of measure:  G/cm^2
Number Analyzed 1170 participants
0.680  (0.1239)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1170 participants
-2.46  (0.965)
[1]
Measure Description:

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] 
Mean (Standard Deviation)
Unit of measure:  G/cm^2
Number Analyzed 1170 participants
0.763  (0.1480)
[1]
Measure Description: The total number of participants for whom baseline spine bone mineral density data was available was 738.
Spine T-score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 1170 participants
-3.10  (1.130)
[1]
Measure Description: The total number of participants for whom Baseline spine T-score data was available was 954.
Number of Participants With at Least One Fracture  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1170 participants
904
Was Patient/relative/helper instructed in PTH(1-84) (self) injection technique?  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1170 participants
Yes 1167
No 1
Missing 2
1.Primary Outcome
Title Number of Participants Who Discontinued Before 6 Months of Treatment
Hide Description A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Parathyroid Hormone (PTH) (1-84)
Hide Arm/Group Description:
PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
Overall Number of Participants Analyzed 1170
Measure Type: Number
Unit of Measure: participants
181
2.Secondary Outcome
Title Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment
Hide Description A participant was defined as “permanently discontinued” if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards. A participant was defined as “temporarily discontinued” if treatment with PTH(1-84) was not ongoing at the time point but was then ongoing at a future time point. This was the case when a participant or investigator wanted to pause the treatment for a length of time (e.g. because of an adverse event or interruption). Therefore, a participant was defined as still “ongoing” during the trial if treatment with PTH(1-84) had not been permanently or temporarily discontinued at that time point. A participant was only defined as “missing” or “unknown” if they attended the relevant visit and there was no result or “unknown” was entered as the result. Results for months 3, 12, 18 and 24 are cumulative data up until that time point.
Time Frame From enrollment to 3, 12, 18, and 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title 3 Months 12 Months 18 Months 24 Months
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1170 1170 1170 1170
Measure Type: Number
Unit of Measure: participants
Permanently discontinued 75 198 284 525
Temporarily discontinued 6 8 2 2
Ongoing 898 847 709 375
Unknown 0 0 0 0
Missing 191 117 175 268
3.Secondary Outcome
Title Duration of Treatment
Hide Description Duration of treatment was defined as the last known date that PTH(1-84) was taken minus the first date that PTH(1-84) was taken plus one. In the calculation of duration, no adjustment was made for the prescribed dose frequency or for periods of temporary discontinuation due to adverse drug reactions (ADRs) or temporary patient suspension of treatment.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants for whom data were available
Arm/Group Title Parathyroid Hormone (PTH) (1-84)
Hide Arm/Group Description:
PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
Overall Number of Participants Analyzed 1156
Mean (Full Range)
Unit of Measure: months
17.7
(0 to 35)
4.Secondary Outcome
Title Treatment Compliance by Visit
Hide Description

A participant was defined as compliant if the participant took the treatment as prescribed by the Physician, i.e. complied with the Physician’s advice and followed the treatment regimen prescribed. A participant whose dose frequency and treatment length were changed during treatment, e.g. in response to a raised serum calcium level, was regarded as fully compliant if the revised treatment regimen was adhered to.

Data on compliance were obtained at each visit and relate to the period since the previous recorded visit.

Time Frame From enrollment to 3, 6, 12, 18, and 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3 Months 6 Months 12 Months 18 Months 24 Months
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1170 1170 1170 1170 1170
Measure Type: Number
Unit of Measure: participants
Compliant 875 845 800 721 558
Non-compliant 105 80 95 89 93
Missing 190 245 275 360 519
Time Frame 24 months
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings related to the treatment.
 
Arm/Group Title Parathyroid Hormone (PTH) (1-84)
Hide Arm/Group Description PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
All-Cause Mortality
Parathyroid Hormone (PTH) (1-84)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Parathyroid Hormone (PTH) (1-84)
Affected / at Risk (%)
Total   10/1170 (0.85%) 
Gastrointestinal disorders   
Abdominal pain  1  1/1170 (0.09%) 
Diarrhoea  1  1/1170 (0.09%) 
Nausea  1  1/1170 (0.09%) 
General disorders   
Pain  1  1/1170 (0.09%) 
Injury, poisoning and procedural complications   
Fall  1  1/1170 (0.09%) 
Investigations   
Blood calcium increased  1  1/1170 (0.09%) 
Weight decreased  1  2/1170 (0.17%) 
Metabolism and nutrition disorders   
Hypercalcaemia  1  4/1170 (0.34%) 
Nervous system disorders   
Dizziness  1  1/1170 (0.09%) 
Headache  1  1/1170 (0.09%) 
Tremor  1  1/1170 (0.09%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/1170 (0.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Parathyroid Hormone (PTH) (1-84)
Affected / at Risk (%)
Total   276/1170 (23.59%) 
Cardiac disorders   
Palpitations  1  5/1170 (0.43%) 
Tachycardia  1  5/1170 (0.43%) 
Ear and labyrinth disorders   
Motion sickness  1  3/1170 (0.26%) 
Tinnitus  1  1/1170 (0.09%) 
Vertigo  1  5/1170 (0.43%) 
Endocrine disorders   
Hyperparathyroidism  1  1/1170 (0.09%) 
Eye disorders   
Panophthalmitis  1  1/1170 (0.09%) 
Visual impairment  1  1/1170 (0.09%) 
Gastrointestinal disorders   
Abdominal discomfort  1  3/1170 (0.26%) 
Abdominal pain  1  1/1170 (0.09%) 
Abdominal pain upper  1  4/1170 (0.34%) 
Constipation  1  4/1170 (0.34%) 
Diarrhoea  1  5/1170 (0.43%) 
Dyspepsia  1  1/1170 (0.09%) 
Nausea  1  66/1170 (5.64%) 
Reflux gastritis  1  1/1170 (0.09%) 
Vomiting  1  16/1170 (1.37%) 
General disorders   
Asthenia  1  4/1170 (0.34%) 
Chest discomfort  1  1/1170 (0.09%) 
Chills  1  2/1170 (0.17%) 
Discomfort  1  1/1170 (0.09%) 
Fatigue  1  6/1170 (0.51%) 
Feeling abnormal  1  1/1170 (0.09%) 
Gait disturbance  1  1/1170 (0.09%) 
Influenza like illness  1  1/1170 (0.09%) 
Injection site haematoma  1  1/1170 (0.09%) 
Injection site reaction  1  1/1170 (0.09%) 
Malaise  1  9/1170 (0.77%) 
Pain  1  4/1170 (0.34%) 
Pyrexia  1  1/1170 (0.09%) 
Infections and infestations   
Influenza  1  1/1170 (0.09%) 
Nasopharyngitis  1  1/1170 (0.09%) 
Investigations   
Blood alkaline phosphatase increased  1  3/1170 (0.26%) 
Blood calcium abnormal  1  1/1170 (0.09%) 
Blood pressure systolic increased  1  1/1170 (0.09%) 
Weight decreased  1  2/1170 (0.17%) 
Weight increased  1  1/1170 (0.09%) 
Metabolism and nutrition disorders   
Anorexia  1  3/1170 (0.26%) 
Decreased appetite  1  5/1170 (0.43%) 
Hypercalcaemia  1  123/1170 (10.51%) 
Hypocalcaemia  1  1/1170 (0.09%) 
Hypocalcemia  1  1/1170 (0.09%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  6/1170 (0.51%) 
Arthropathy  1  1/1170 (0.09%) 
Back pain  1  6/1170 (0.51%) 
Bone pain  1  2/1170 (0.17%) 
Mobility decreased  1  1/1170 (0.09%) 
Muscle spasms  1  6/1170 (0.51%) 
Muscular weakness  1  3/1170 (0.26%) 
Musculoskeletal discomfort  1  1/1170 (0.09%) 
Musculoskeletal pain  1  1/1170 (0.09%) 
Musculoskeletal stiffness  1  1/1170 (0.09%) 
Myalgia  1  3/1170 (0.26%) 
Pain in extremity  1  2/1170 (0.17%) 
Nervous system disorders   
Balance disorder  1  1/1170 (0.09%) 
Burning sensation mucosal  1  1/1170 (0.09%) 
Dizziness  1  20/1170 (1.71%) 
Dysgeusia  1  1/1170 (0.09%) 
Encephalopathy  1  1/1170 (0.09%) 
Headache  1  27/1170 (2.31%) 
Paraesthesia  1  1/1170 (0.09%) 
Transient ischaemic attack  1  1/1170 (0.09%) 
Tremor  1  2/1170 (0.17%) 
Psychiatric disorders   
Depression  1  3/1170 (0.26%) 
Restlessness  1  1/1170 (0.09%) 
Sleep disorder  1  1/1170 (0.09%) 
Renal and urinary disorders   
Hypercalciuria  1  1/1170 (0.09%) 
Nephrolithiasis  1  1/1170 (0.09%) 
Nocturia  1  1/1170 (0.09%) 
Pollakiuria  1  2/1170 (0.17%) 
Reproductive system and breast disorders   
Pelvic pain  1  1/1170 (0.09%) 
Respiratory, thoracic and mediastinal disorders   
Asphyxia  1  1/1170 (0.09%) 
Dyspnoea  1  2/1170 (0.17%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  8/1170 (0.68%) 
Hyperhidrosis  1  1/1170 (0.09%) 
Lipoatrophy  1  1/1170 (0.09%) 
Petechiae  1  1/1170 (0.09%) 
Pruritus  1  2/1170 (0.17%) 
Pruritus generalised  1  1/1170 (0.09%) 
Rash  1  1/1170 (0.09%) 
Rash generalised  1  1/1170 (0.09%) 
Rash papulosquamous  1  1/1170 (0.09%) 
Vascular disorders   
Circulatory collapse  1  1/1170 (0.09%) 
Haematoma  1  1/1170 (0.09%) 
Hot flush  1  4/1170 (0.34%) 
Hypertension  1  2/1170 (0.17%) 
Hypertensive crisis  1  1/1170 (0.09%) 
Hypotension  1  1/1170 (0.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
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
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