CClinicalTrials.gg
CompletedNCT02472782IASISUpdated Jan 10, 2019

Adherence to Osteoporosis Treatment and Physicians' Perception Regarding Osteoporosis Medication

An observational study in Osteoporosis, Postmenopausal and Osteoporosis, Steroid Induced, sponsored by 251 Hellenic Air Force & VA General Hospital. Completed at 1 site in Greece. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2019-01-10.

Sponsored by 251 Hellenic Air Force & VA General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
851
Ages
35 Years and older
Sex
All
01

Study summary

This is a study aiming to investigate a possible correlation between the parameters affecting the physicians' therapeutic choice with the patients' overall adherence to osteoporosis treatment. Secondary end-points include correlation between the parameters affecting the physicians' therapeutic choice and the patients' quality of life as well as the evaluation of the whole osteoporosis treatment approach of orthopedic surgeons in Greece (diagnostic means, use of diagnostic and treatment guidelines, methodology of follow - up).

Read the detailed description

The study will include 100 orthopedic surgeons from the private sector working in private offices. The selection of this group of physicians resides on the fact that orthopedic surgeons working in private offices hold more than 60% of osteoporosis prescriptions in Greece.

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

02

Conditions studied

  • Osteoporosis, Postmenopausal
  • Osteoporosis, Steroid Induced

Keywords

  • osteoporosis
  • quality of life
  • adherence
  • treatment
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 851 is above the median of 174 across 446 observational studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

251 Hellenic Air Force & VA General Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Female patients with postmenopausal osteoporosis

Male patients ≥ 50 years old with idiopathic osteoporosis

Male and female patients with steroid-induced osteoporosis

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
851 participants (actual)
Target follow-up
2 Years
Patient registry
Yes

Interventions

  • DrugTeriparatide

    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

    Also known as: osteo-anabolic treatment

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What researchers measure

Primary outcomes

  1. Adherence to osteoporosis treatment assessed by medication possession ratio (MPR)

    Adherence to osteoporosis treatment assessed by medication possession ratio Adherence to osteoporosis treatment assessed by medication possession ratio (MPR) and correlation with the parameters affecting the physicians' therapeutic choices

    Time frame: 2 years

Secondary outcomes

  1. Quality of life assessed by EQ5D questionnaire

    Quality of life assessed by EQ5D questionnaire and correlation with the parameters affecting the physicians' therapeutic choice

    Time frame: 2 years

07

Study locations

1 site
  • 251 Hellenic Air Force & VA General Hospital
    Athens, Attiki 11525, Greece
08

References and documents

Publications

  • 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. PubMed 18661089 ↗
  • 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. PubMed 23064370 ↗
  • 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. PubMed 18237359 ↗
  • 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. PubMed 16330270 ↗
  • 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. PubMed 21308365 ↗
  • 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. PubMed 20838773 ↗
  • 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. PubMed 16823543 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02472782
Lead sponsor
251 Hellenic Air Force & VA General Hospital
Collaborators
Hellenic Osteoporosis Foundation (www.http://heliost.gr/en/)
Responsible party
Dr Polyzois Makras (Deputy Director, Dpt of Endocrinology & Diabetes, 251 Hellenic Air Force & VA General Hospital) — Principal investigator
First posted
Jun 16, 2015
Start date
May 2015
Primary completion
Jun 30, 2018
Completion
Dec 15, 2018
Last update
Jan 10, 2019

Study contacts

George Lyritis, Professor
study chair · Hellenic Osteoporosis Foundation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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