N/A
Completed N=1,170
Adherence to PTH(1-84) Treatment (FP-002-IM)
Clinical Use of PTH(1-84)
Source: ClinicalTrials.gov NCT00478569 ↗
Enrolled (actual)
1,170
Serious AEs
0.9%
Results posted
May 2014
Primary outcomePrimary: Number of Participants Who Discontinued Before 6 Months of Treatment — 181 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Discontinued Before 6 Months of Treatment |
181 | — |
| SECONDARY Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment |
75; 198; 284; 525; 6; 8 | — |
| SECONDARY Duration of Treatment |
17.7 | — |
| SECONDARY Treatment Compliance by Visit |
875; 845; 800; 721; 558; 105 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00478569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.