Clinical Use of PTH(1-84)
Conditions
Brief summary
The primary objective is: 1\) to describe adherence (and the main factors influencing adherence) to PTH(1-84) treatment when prescribed in a normal clinical setting. The secondary objectives are: 1. to describe the demographics and clinical characteristics of the patients that in a normal clinical setting are started on a treatment regimen with PTH(1-84) 2. to describe (using available data) the long term treatment effectiveness during the 24 months following initiation of PTH(1-84) treatment in a normal clinical setting 3. to monitor safety for 24 months following initiation of PTH(1-84) treatment in a patient in a normal clinical setting.
Interventions
Adherence to PTH(1-84) treatment in Usual Clinical Settings
Sponsors
Takeda
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* According to the current Summary of Product Characteristics (SmPC) * PTH(1-84) treatment initiated within one month preceding enrolment * The patient's written informed consent to direct access and data processing must be obtained.
Exclusion criteria
* According to the current SmPC * The patient cannot participate in a clinical trial with PTH (all other trials allowed).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinued Before 6 Months of Treatment | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | From enrollment to 3, 12, 18, and 24 months | 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. |
| Duration of Treatment | 24 months | 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. |
| Treatment Compliance by Visit | From enrollment to 3, 6, 12, 18, and 24 months | 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. |
Countries
Denmark
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,170 |
| Total | 1,170 |
Baseline characteristics
| Characteristic | Parathyroid Hormone (PTH) (1-84) |
|---|---|
| Age at Onset of Menopause | 47.9 years STANDARD_DEVIATION 5.49 |
| Age at Onset of Menopause by Category ≤ 45 years | 283 participants |
| Age at Onset of Menopause by Category > 45 years | 749 participants |
| Age at Onset of Menopause by Category Missing | 116 participants |
| Age, Continuous | 72.3 years STANDARD_DEVIATION 9.05 |
| Alcohol Consumption Daily | 50 participants |
| Alcohol Consumption Missing | 26 participants |
| Alcohol Consumption Never | 709 participants |
| Alcohol Consumption Occasionally | 385 participants |
| Body Mass Index (BMI) | 25.9 kg/m^2 STANDARD_DEVIATION 4.59 |
| Calcium and/or Vitamin D Supplement Missing | 2 participants |
| Calcium and/or Vitamin D Supplement No | 122 participants |
| Calcium and/or Vitamin D Supplement Yes | 1046 participants |
| Current Smoker Missing | 2 participants |
| Current Smoker No | 1057 participants |
| Current Smoker Yes | 111 participants |
| Family History of Osteoporosis Missing | 50 participants |
| Family History of Osteoporosis No | 896 participants |
| Family History of Osteoporosis Unknown | 1 participants |
| Family History of Osteoporosis Yes | 223 participants |
| Glucocorticosteroid Use Missing | 3 participants |
| Glucocorticosteroid Use No | 1038 participants |
| Glucocorticosteroid Use Yes | 129 participants |
| Height | 156.3 cm STANDARD_DEVIATION 7.98 |
| Number of Participants With at Least One Fracture | 904 participants |
| Past Smoker Missing | 2 participants |
| Past Smoker No | 1009 participants |
| Past Smoker Yes | 159 participants |
| PTH (1-84) Dosing Frequency Every Other Day | 6 participants |
| PTH (1-84) Dosing Frequency Missing | 2 participants |
| PTH (1-84) Dosing Frequency Once Daily | 1162 participants |
| Race/Ethnicity, Customized African | 1 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Caucasian | 1165 participants |
| Race/Ethnicity, Customized Missing | 2 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Region of Enrollment Austria | 158 participants |
| Region of Enrollment Denmark | 79 participants |
| Region of Enrollment Germany | 246 participants |
| Region of Enrollment Greece | 300 participants |
| Region of Enrollment Ireland | 29 participants |
| Region of Enrollment Netherlands | 65 participants |
| Region of Enrollment Spain | 272 participants |
| Region of Enrollment United Kingdom | 21 participants |
| Sex/Gender, Customized Female | 1149 participants |
| Sex/Gender, Customized Male | 19 participants |
| Sex/Gender, Customized Missing | 2 participants |
| Spine Bone Mineral Density (BMD) | 0.763 g/cm^2 STANDARD_DEVIATION 0.148 |
| Spine T-score | -3.10 units on a scale STANDARD_DEVIATION 1.13 |
| Time Since Starting PTH(1-84) | 8.1 days STANDARD_DEVIATION 15.52 |
| Total Hip Bone Mineral Density (BMD) | 0.680 g/cm^2 STANDARD_DEVIATION 0.1239 |
| Total Hip T-score | -2.46 units on a scale STANDARD_DEVIATION 0.965 |
| Type of Menopause Missing | 20 participants |
| Type of Menopause Natural | 966 participants |
| Type of Menopause Other | 25 participants |
| Type of Menopause Surgical | 137 participants |
| Was Patient/relative/helper instructed in PTH(1-84) (self) injection technique? Missing | 2 participants |
| Was Patient/relative/helper instructed in PTH(1-84) (self) injection technique? No | 1 participants |
| Was Patient/relative/helper instructed in PTH(1-84) (self) injection technique? Yes | 1167 participants |
| Weight | 63.4 kg STANDARD_DEVIATION 12.25 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 276 / 1,170 |
| serious Total, serious adverse events | 10 / 1,170 |
Outcome results
Primary
Number of Participants Who Discontinued Before 6 Months of Treatment
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
Population: All enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parathyroid Hormone (PTH) (1-84) | Number of Participants Who Discontinued Before 6 Months of Treatment | 181 participants |
Secondary
Duration of Treatment
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
Population: Participants for whom data were available
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Parathyroid Hormone (PTH) (1-84) | Duration of Treatment | 17.7 months |
Secondary
Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment
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
Population: All enrolled participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parathyroid Hormone (PTH) (1-84) | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Ongoing | 898 participants |
| Parathyroid Hormone (PTH) (1-84) | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Unknown | 0 participants |
| Parathyroid Hormone (PTH) (1-84) | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Permanently discontinued | 75 participants |
| Parathyroid Hormone (PTH) (1-84) | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Temporarily discontinued | 6 participants |
| Parathyroid Hormone (PTH) (1-84) | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Missing | 191 participants |
| 12 Months | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Ongoing | 847 participants |
| 12 Months | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Unknown | 0 participants |
| 12 Months | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Temporarily discontinued | 8 participants |
| 12 Months | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Permanently discontinued | 198 participants |
| 12 Months | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Missing | 117 participants |
| 18 Months | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Ongoing | 709 participants |
| 18 Months | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Permanently discontinued | 284 participants |
| 18 Months | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Temporarily discontinued | 2 participants |
| 18 Months | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Unknown | 0 participants |
| 18 Months | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Missing | 175 participants |
| 24 Months | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Unknown | 0 participants |
| 24 Months | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Temporarily discontinued | 2 participants |
| 24 Months | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Permanently discontinued | 525 participants |
| 24 Months | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Ongoing | 375 participants |
| 24 Months | Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment | Missing | 268 participants |
Secondary
Treatment Compliance by Visit
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parathyroid Hormone (PTH) (1-84) | Treatment Compliance by Visit | Compliant | 875 participants |
| Parathyroid Hormone (PTH) (1-84) | Treatment Compliance by Visit | Missing | 190 participants |
| Parathyroid Hormone (PTH) (1-84) | Treatment Compliance by Visit | Non-compliant | 105 participants |
| 12 Months | Treatment Compliance by Visit | Non-compliant | 80 participants |
| 12 Months | Treatment Compliance by Visit | Compliant | 845 participants |
| 12 Months | Treatment Compliance by Visit | Missing | 245 participants |
| 18 Months | Treatment Compliance by Visit | Non-compliant | 95 participants |
| 18 Months | Treatment Compliance by Visit | Compliant | 800 participants |
| 18 Months | Treatment Compliance by Visit | Missing | 275 participants |
| 24 Months | Treatment Compliance by Visit | Compliant | 721 participants |
| 24 Months | Treatment Compliance by Visit | Missing | 360 participants |
| 24 Months | Treatment Compliance by Visit | Non-compliant | 89 participants |
| 24 Months | Treatment Compliance by Visit | Non-compliant | 93 participants |
| 24 Months | Treatment Compliance by Visit | Compliant | 558 participants |
| 24 Months | Treatment Compliance by Visit | Missing | 519 participants |