Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday (CONTINUITY)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01854086
First received: May 6, 2013
Last updated: May 12, 2013
Last verified: May 2013
  Purpose

The purpose of the study is to provide information about the rate of response and persistence to drug therapies for osteoporosis. Another issue examined in this study refers to the preferences and concerns about future treatments in patients during "drug holiday".


Condition Intervention
Osteoporosis
Other: Questionnaires about compliance and persistence with bisphosphonates treatment

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday: Data From a Single Outpatient Endocrine Clinic.

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Compliance and persistence to osteoporosis drug therapy [ Time Frame: Participants will be followed for the duration of their clinic visit, an average of 5 hours ] [ Designated as safety issue: No ]
    Data collection will be done by questionnaires and from the medical record of the patient. The information collected will include: demographic information, measurements of bone density, additional information about the disease and treatment that the patient receives,prescription purchases and additional drugs the patient is taking (steroids, PPI's(Proton Pump Inhibitors) / H2 receptor antagonists and NSAIDs(Non Steroidal Anti Inflammatories)).


Estimated Enrollment: 150
Study Start Date: September 2013
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Postmenopausal women
Postmenopausal women treated with bisphosphonates
Other: Questionnaires about compliance and persistence with bisphosphonates treatment

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with osteoporosis,who been treated in Endocrinology Clinic of Medical Center

Criteria

Inclusion Criteria:

  • Postmenopausal women
  • Diagnosis of osteoporosis in the medical record
  • At least one prescription drug to treat osteoporosis in the last 5 years
  • Insured by "Clalit" Health Services
  • Hebrew-speaking capability and readiness to answer a questionnaire

Exclusion Criteria:

  • Premenopausal women
  • No diagnosis of osteoporosis in the medical record
  • No treatment for osteoporosis in the last 5 years
  • Women who do not speak Hebrew or are unable to answer a questionnaire
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854086

Contacts
Contact: Pnina Rotman, M.D 972-57-7482609 Pnina.Rotman@clalit.org.il

Locations
Israel
Meir medical center the clalit health care services group Not yet recruiting
Kfar Saba, Israel, 44281
Contact: Pnina Rotman, M.D    972-57-7482609    Pnina.Rotman@clalit.org.il   
Principal Investigator: Pnina Rotman, M.D         
Sponsors and Collaborators
Meir Medical Center
  More Information

Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01854086     History of Changes
Other Study ID Numbers: MMC130009-13CTIL
Study First Received: May 6, 2013
Last Updated: May 12, 2013
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
osteoporosis
postmenopausal
patient compliance
compliance
diphosphonates
bisphosphonates

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014