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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02472782 |
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Date of registration:
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10/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Adherence to Osteoporosis Treatment and Physicians' Perception Regarding Osteoporosis Medication
IASIS |
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Scientific title:
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Prospective,Non-interventional Study Investigating Possible Correlation Between Adherence to Postmenopausal and Steroid Induced Osteoporosis Treatment and Physicians' Perception Regarding Osteoporosis Medication |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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851 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02472782 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Greece
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Contacts
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Name:
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George Lyritis, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hellenic Osteoporosis Foundation |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female patients with postmenopausal osteoporosis (T-score =-2,5 SD at any skeletal
site) under osteoporosis treatment (except teriparatide) for at least one year with a
history of = low-energy fracture during the last 10 years prior the study.
- Male patients = 50 years old with idiopathic osteoporosis (T-score =-2,5 SD at any
skeletal site) under osteoporosis treatment (except teriparatide) for at least one
year with a history of = low-energy fracture during the last 10 years prior the study.
- Male and female patients with steroid-induced osteoporosis (T-score =-2,5 SD at any
skeletal site) under osteoporosis treatment (except teriparatide) for at least one
year with a history of = low-energy fracture during the last 10 years prior the study.
Exclusion Criteria:
- Prior use of teriparatide or PTH(1-84)
- Hypersensitivity to teriparatide regimen.
- Pregnancy and lactation.
- Hypercalcamia.
- Renal deficiency (eGFR < 30 ml/min).
- Other bone metabolic diseases (including hyperparathyroidism and Paget's disease)
except primary osteoporosis or steroid induced osteoporosis .
- Uninterpretable increases of alkaline phosphatase (ALP)
- Prior skeletal radiotherapy.
- Skeletal malignancies or bone metastases
Age minimum:
35 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoporosis, Postmenopausal
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Osteoporosis, Steroid Induced
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Intervention(s)
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Drug: Teriparatide
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Primary Outcome(s)
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Adherence to osteoporosis treatment assessed by medication possession ratio (MPR)
[Time Frame: 2 years]
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Secondary Outcome(s)
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Quality of life assessed by EQ5D questionnaire
[Time Frame: 2 years]
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Secondary ID(s)
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076/AD7592/S1684/6-5-2015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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