Adherence to Osteoporosis Treatment and Physicians' Perception Regarding Osteoporosis Medication
NCT ID: NCT02472782
Last Updated: 2019-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
851 participants
OBSERVATIONAL
2015-05-31
2018-12-15
Brief Summary
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Detailed Description
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Each physician will fill once a questionnaire regarding the parameters affecting his/her choice of osteoporosis treatment before entering any patient in the study. Following the completion of the questionnaire every physician will recruit up to 10 patients in the study who are eligible for osteoanabolic treatment (teriparatide) according to standard medical practice and the Greek osteoporosis treatment guidelines.
Each patient will receive teriparatide up to 24 months while he/she will fill the Greek EQ5D questionnaire on months: 0,12,24 or at early discontinuation. Adherence to treatment will be evaluated at the same time points as well as on monthly telephone interviews.
Both the adherence to treatment and the possible alteration of patients' quality of life (evaluated through the EQ5D questionnaire) during the study will be correlated with the parameters affecting the initial therapeutic decision of the physician
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Teriparatide
The study will include patients from pre-defined groups of individuals (postmenopausal, male, and steroid-induced osteoporosis) who would any way receive teriparatide for their condition according to standard medical practice and Greek treatment guidelines
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
ALL
No
Sponsors
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Hellenic Osteoporosis Foundation (www.http://heliost.gr/en/)
UNKNOWN
251 Hellenic Air Force & VA General Hospital
OTHER
Responsible Party
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Dr Polyzois Makras
Deputy Director, Dpt of Endocrinology & Diabetes
Principal Investigators
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George Lyritis, Professor
Role: STUDY_CHAIR
Hellenic Osteoporosis Foundation
Locations
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251 Hellenic Air Force & VA General Hospital
Athens, Attica, Greece
Countries
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References
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Briot K, Ravaud P, Dargent-Molina P, Zylberman M, Liu-Leage S, Roux C. Persistence with teriparatide in postmenopausal osteoporosis; impact of a patient education and follow-up program: the French experience. Osteoporos Int. 2009 Apr;20(4):625-30. doi: 10.1007/s00198-008-0698-8. Epub 2008 Jul 26.
Lyritis GP, Rizou S, Galanos A, Makras P. Incidence of hip fractures in Greece during a 30-year period: 1977-2007. Osteoporos Int. 2013 May;24(5):1579-85. doi: 10.1007/s00198-012-2154-z. Epub 2012 Oct 13.
Cramer JA, Roy A, Burrell A, Fairchild CJ, Fuldeore MJ, Ollendorf DA, Wong PK. Medication compliance and persistence: terminology and definitions. Value Health. 2008 Jan-Feb;11(1):44-7. doi: 10.1111/j.1524-4733.2007.00213.x.
Huybrechts KF, Ishak KJ, Caro JJ. Assessment of compliance with osteoporosis treatment and its consequences in a managed care population. Bone. 2006 Jun;38(6):922-8. doi: 10.1016/j.bone.2005.10.022. Epub 2005 Dec 5.
Hadji P, Claus V, Ziller V, Intorcia M, Kostev K, Steinle T. GRAND: the German retrospective cohort analysis on compliance and persistence and the associated risk of fractures in osteoporotic women treated with oral bisphosphonates. Osteoporos Int. 2012 Jan;23(1):223-31. doi: 10.1007/s00198-011-1535-z. Epub 2011 Feb 10.
Netelenbos JC, Geusens PP, Ypma G, Buijs SJ. Adherence and profile of non-persistence in patients treated for osteoporosis--a large-scale, long-term retrospective study in The Netherlands. Osteoporos Int. 2011 May;22(5):1537-46. doi: 10.1007/s00198-010-1372-5. Epub 2010 Sep 14.
Arden NK, Earl S, Fisher DJ, Cooper C, Carruthers S, Goater M. Persistence with teriparatide in patients with osteoporosis: the UK experience. Osteoporos Int. 2006;17(11):1626-9. doi: 10.1007/s00198-006-0171-5. Epub 2006 Jul 6.
Other Identifiers
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076/AD7592/S1684/6-5-2015
Identifier Type: -
Identifier Source: org_study_id
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