Adherence to Osteoporosis Treatment and Physicians' Perception Regarding Osteoporosis Medication

NCT02472782 | Completed

• 1 other identifier: 076/AD7592/S1684/6-5-2015
• Study Type: observational
• Target: 851
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Osteoporosis, Postmenopausal; Osteoporosis, Steroid Induced

Keywords

osteoporosis; quality of life; adherence; treatment

Outcome Measures

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

  2 years

Secondary Outcomes (1)

• Quality of life assessed by EQ5D questionnaire

  2 years

Interventions

Teriparatide DRUG

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

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• 251 Hellenic Air Force & VA General Hospital: lead
• Hellenic Osteoporosis Foundation (www.http://heliost.gr/en/): collaborator

Study Sites (1)

251 Hellenic Air Force & VA General Hospital

Athens, Attica, 11525, Greece

Location

Related Publications (7)

• 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.

  PMID: 18661089 BACKGROUND

• 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.

  PMID: 23064370 BACKGROUND

• 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.

  PMID: 18237359 BACKGROUND

• 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.

  PMID: 16330270 BACKGROUND

• 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.

  PMID: 21308365 BACKGROUND

• 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.

  PMID: 20838773 BACKGROUND

• 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.

  PMID: 16823543 BACKGROUND

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• George Lyritis, Professor

  Hellenic Osteoporosis Foundation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Dpt of Endocrinology & Diabetes

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 16, 2015
• Study Start: May 1, 2015
• Primary Completion: June 30, 2018
• Study Completion: December 15, 2018
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

GR (1)